Original Research
Vascular and Interventional Radiology
March 16, 2018

Interventional Radiology–Operated Cholecystoscopy for the Management of Symptomatic Cholelithiasis: Approach, Technical Success, Safety, and Clinical Outcomes

Abstract

OBJECTIVE. The objective of our study was to report the technique, complications, and clinical outcomes of interventional radiology–operated cholecystoscopy with stone removal for the management of symptomatic cholelithiasis.
MATERIALS AND METHODS. Ten (77%) men and three (23%) women (mean age, 65 years) with symptomatic cholelithiasis underwent cholecystostomy followed by interventional radiology–operated cholecystoscopy with stone removal. Major comorbidities precluding cholecystectomy included prior cardiac, pulmonary, or abdominal surgery; cirrhosis; sepsis with hyponatremia; seizure disorder; developmental delay; and cholecystoduodenal fistula. Cholecystostomy access, time between cholecystostomy and cholecystoscopy, endoscopic and fragmentation devices used, technical success, procedure time, fluoroscopy time, complications, length of hospital stay, time between cholecystoscopy and cholecystostomy removal, follow-up, and acute cholecystitis recurrence were recorded.
RESULTS. Eleven (85%) patients underwent transhepatic cholecystostomy, and two (15%) patients underwent transperitoneal cholecystostomy. The mean time from cholecystostomy to cholecystoscopy was 151 days. Flexible endoscopy was used in eight (62%) patients, rigid endoscopy in three (23%), and both flexible and rigid in two (15%). Electrohydraulic lithotripsy was used in eight procedures, nitinol baskets in seven, ultrasonic lithotripsy in two, and percutaneous thrombectomy devices in one. Primary technical success was achieved in 11 (85%) patients, and secondary technical success was achieved in 13 (100%) patients. The mean procedure time was 164 minutes, and the mean number of procedures required to clear all gallstones was 1. One (8%) patient developed acute pancreatitis, and one (8%) patient died of gastrointestinal hemorrhage. The median hospital length of stay after cholecystoscopy was 1 day for postoperative monitoring. The mean time between cholecystoscopy and cholecystostomy removal was 39 days. One (8%) patient developed recurrent acute cholecystitis 1095 days after cholecystoscopy.
CONCLUSION. Interventional radiology–operated cholecystoscopy may serve as an effective method for percutaneous gallstone removal in patients with multiple comorbidities precluding cholecystectomy.
Gallstones have an annual incidence of 1 in 200 persons, with 1–4% of those cases resulting in symptomatic disease [1]. Percutaneous cholecystostomy has become the treatment of choice for acute calculous cholecystitis in high-risk patients with multiple medical comorbidities [24]. Unfortunately, many patients require long-term or life-long cholecystostomy because they are poor surgical candidates and are ineligible for cholecystectomy [5, 6]. In patients treated without cholecystectomy, recurrence of acute cholecystitis after cholecystostomy removal due to untreated cholelithiasis is seen in more than 33% of patients [6].
Early studies suggested cholecystectomy after cholecystostomy was optimal compared with cholecystostomy and medical management alone; however, many patients are ineligible for laparoscopic cholecystectomy [5, 6]. Nonsurgical treatment techniques for stone removal include medical dissolution, extracorporeal shock wave lithotripsy, mechanical lithotripsy, electrohydraulic lithotripsy, and laser lithotripsy and have technical success rates of 95% and cholelithiasis recurrence rates of less than 5% [712]. There are several dated studies reporting management of symptomatic cholelithiasis with percutaneous cholecystoscopy and stone removal [712].
The largest study examining the feasibility and efficacy of percutaneous cholecystoscopy was performed by Ohashi [13], was published in 1998, and included patients treated between 1987 and 1994. Endoscopy devices and lithotripsy techniques were just beginning to be described in the literature in the early 1990s and have undergone significant advances since then, resulting in low-profile devices and more readily available technologies [12]. The period from 1994 to 2009 saw a 576% increase in the number of percutaneous cholecystostomy drains placed for acute cholecystitis [14]. Thus, the aging population with chronic illnesses, increasing use of cholecystostomy, and improved endoscopy and lithotripsy technologies have created an environment for definitive treatment of symptomatic cholelithiasis performed entirely by interventional radiologists.
This study reports the technique, technical success, complications, and clinical outcomes of interventional radiology–operated cholecystoscopy with stone removal for the management of symptomatic cholelithiasis after percutaneous cholecystostomy placement in patients who are ineligible for cholecystectomy.

Materials and Methods

Patient Selection

This study received institutional review board approval and complied with the HIPAA. Informed consent was not required for this retrospective study. Patients were identified via retrospective review of the electronic medical record (EPIC, Epic Systems) in conjunction with a prospectively maintained cholecystoscopy registry (Microsoft Excel 2017). All patients with symptomatic acute calculous cholelithiasis who underwent cholecystostomy followed by interventional radiology–operated cholecystoscopy with stone removal between October 2010 and March 2017 (78 months) were identified.

Inclusion and Exclusion Criteria

All patients who underwent cholecystoscopy with stone removal were considered for inclusion in this study (n = 17). Inclusion criteria were adult patients older than 18 years old with imaging-proven symptomatic acute calculous cholelithiasis who were not otherwise surgical candidates for open or laparoscopic cholecystectomy because of medical comorbidities and who had favorable anatomy for cholecystostomy and cholecystoscopy. Favorable anatomy consisted of a normally positioned gall-bladder with an intercostal window, a small amount of liver parenchyma between the upper abdominal subcutaneous tissues and gallbladder without interposed bowel, a mass, or ascites. Patients were excluded if they did not meet these criteria, had uncorrectable coagulopathy, had a life expectancy of less than 6 months, or had no follow-up after cholecystoscopy (n = 4). A total of 13 patients met the inclusion criteria; four patients were excluded.

Measured Variables

Age, sex, presenting symptoms, initial imaging examination, medical comorbidities precluding cholecystectomy, cholecystostomy access, time between cholecystostomy and cholecystoscopy, endoscopic and fragmentation devices used, stone removal technical success, procedure time, fluoroscopy time, complications, length of hospital stay, time between cholecystoscopy and cholecystostomy removal, follow-up, and acute cholecystitis recurrence were recorded.

Patient Demographics

The study group (n = 13) consisted of 10 (77%) men and three (23%) women with a mean age of 65 years (range, 48–90 years). Twelve (92%) patients presented with acute calculous cholecystitis, and one (8%) patient had acute calculous cholecystitis and recurrent cholangitis. Patients had acute calculous cholecystitis diagnosed on one or more of the following: CT (n = 13 examinations), ultrasound (n = 9), or hepatobiliary iminodiacetic acid scanning (n = 2). Medical comorbidities precluding cholecystectomy included prior cardiac (n = 5), pulmonary (n = 4), multiple prior abdominal surgeries (n = 2); cirrhosis (n = 1), sepsis with developmental delay (n = 1), and cholecystoduodenal fistula (n = 1), which was deemed inoperable by the surgeon on the basis of the complexity of the fistula (n =1). One patient had both cardiac and pulmonary comorbidities.

Cholecystostomy, Cholecystoscopy, and Stone Removal Techniques

All patients were seen by an attending interventional radiologist either in clinic or during inpatient consultation before cholecystostomy or cholecystoscopy. Surgical consultation was obtained for all patients. Procedures were performed using moderate sedation with IV midazolam (Versed, Roche) and fentanyl (Sublimaze, Akorn Pharmaceuticals) or general anesthesia administered by a certified nurse anesthetist or attending anesthesiologist. Cholecystostomy placement has been described elsewhere [1, 2]. All patients were given ceftriaxone (Rocephin, Pfizer), with the dose based on weight, before the procedure. Briefly, initial cholecystostomy placement was performed under ultrasound and fluoroscopic guidance via transhepatic or transperitoneal approaches using the Seldinger technique. Cholecystostomy drainage catheters were 7- to 10-French (Dawson-Mueller or Multipurpose Drain, Cook Medical) depending on operator preference. One patient (8%) had a 20-French cholecystostomy catheter (Cope Locking Loop Drain, Cook Medical) placed surgically after cholecystectomy failed because of intraabdominal adhesions. All patients who underwent cholecystostomy placement were scheduled for 4-to 6-week cholecystostomy maintenance exchanges depending on operator preference.
Cholecystoscopy was not planned when cholecystostomy catheters were originally placed. All patients were later deemed to be ineligible for cholecystectomy by a general surgeon on the basis of comorbidities. Patients were subsequently prepared for cholecystoscopy and stone removal. Three interventional radiologists with 1, 5, and 30 years of experience performed all components of the cholecystoscopy and stone removal procedures. Special credentialing was not required for cholecystoscopy given that the endoscopes were owned wholly by the interventional radiology department.
All cholecystostomy drainage catheters were upsized to 12- to 14-French (Mulitpurpose Drain), depending on operator preference, in a single session in preparation for cholecystoscopy. All patients underwent cholecystoscopy and stone removal under general anesthesia administered by a certified nurse anesthetist or attending anesthesiologist because of the use of high-volume enteric saline, which may cause electrolyte imbalances or alter core body temperatures. Although general anesthesia was performed for cholecystoscopy despite the patients' comorbidities, all patients were precluded from surgery because the referring general surgeon thought the patients would be unable to recover from the acute postoperative period after cholecystectomy. Piperacillin and tazobactam (Zosyn, Pfizer), with doses based on weight, were administered to all patients. Orogastric and rectal tubes were placed in all patients to control fluid administration and removal. A normothermia system (Bair Hugger, 3M Company) was used in all patients to maintain body temperature.
Endoscopy was performed with a 7.95-French flexible endoscope (URF-P6, Olympus America) (used with a 14-French sheath), 16.5-French flexible endoscope (CYF-5, Olympus America) (used with a 20-French sheath), or 22.5-French rigid endoscope (WA33036A, Olympus America) (used with a 24-French sheath), depending on the access route, operator preference, and availability of a particular endoscope (Fig. 1). The access route for the rigid endoscope, for example, required direct access to the gallstones while having sufficient room for manipulation. If, for instance, initial cholecystostomy access was too close to the cystic duct, the rigid endoscope would not allow access to the gallbladder fundus.
Fig. 1A —Endoscopes used for interventional radiology–operated cholecystoscopy and stone removal.
A, Photograph of 16.5-French flexible endoscope (CYF-5, Olympus America) with 6-French working channel, which may accept most devices including baskets, electrohydraulic and laser lithotripsy devices, biopsy forceps, and percutaneous thrombectomy devices (Arrow-Trerotola, Teleflex). Pressurized saline is connected to side arm of working channel to aid with visualization.
Fig. 1B —Endoscopes used for interventional radiology–operated cholecystoscopy and stone removal.
B, Photograph of partially assembled flexible endoscope with light source connected; camera display is connected to back of endoscope for visualization on external monitor.
Fig. 1C —Endoscopes used for interventional radiology–operated cholecystoscopy and stone removal.
C, Photograph of 22.5-French rigid endoscope (WA33036A, Olympus America) with 4-mm working channel. Endoscope is placed through 24-French rigid sheath within gallbladder. Light source and video source are connected, and adapter is used to connect pressurized saline to endoscope as well as to aid with visualization. Grasping forceps are seen through working channel of endoscope (arrowhead).
Fig. 1D —Endoscopes used for interventional radiology–operated cholecystoscopy and stone removal.
D, Photograph of tray containing accessories for rigid endoscope shows grasping forceps and baskets, washers and adapters to maintain watertight connections, and 28-French rigid outer sheath for large kidney stones (not used for gallstones).
Fig. 1E —Endoscopes used for interventional radiology–operated cholecystoscopy and stone removal.
E, Photograph shows 24-French Teflon reinforced sheath (X-force, Bard) that is useful for large gallstones, which may require 22.5-French rigid endoscope and ultrasonic lithotripsy device; 16.5-French flexible endoscope is seen within sheath along with two safety guidewires (Amplatz Super Stiff, Boston Scientific).
In all patients, the existing cholecystostomy was removed over a guidewire (Amplatz Super Stiff Guidewire, Boston Scientific). A second guidewire (Amplatz Super Stiff Guidewire) was placed as a safety wire. The transhepatic or transperitoneal tract was dilated using high-pressure 24-French 8 mm × 15 cm nephrostomy balloons (X-Force, Bard). Once the tract was dilated, a sheath (X-Force) was placed and cholecystoscopy was performed (Fig. 1). Devices used for cholelithiasis fragmentation included an electrohydraulic lithotripsy device (REF E-1F and E-3F, Gyrus ACMI), mechanical nitinol stone retrieval basket (ZeroTip, Boston Scientific), sonographic lithotripsy device (ShockPlus SE SPL-T, Olympus America) and percutaneous thrombectomy device (Arrow-Trerotola, Teleflex) (Figs. 2 and 3). The procedures were deemed complete once all stones had been fragmented and removed by endoscopic evaluation (Figs. 4 and 5).
Fig. 2A —Tools for interventional radiology–operated stone removal.
A, Photograph shows generator for electrohydraulic lithotripter. There are connections for soft or hard stones and dials to adjust output and duration of shock pulse delivery. Device is activated using footswitch.
Fig. 2B —Tools for interventional radiology–operated stone removal.
B, Photographs show electrohydraulic lithotripsy probe (REF E-1F and E-3F, Gyrus ACMI). Probe is available in both 1.9- and 3-French sizes and fits through working channel of either 9- or 16.5-French flexible endoscope.
Fig. 2C —Tools for interventional radiology–operated stone removal.
C, Photographs show electrohydraulic lithotripsy probe (REF E-1F and E-3F, Gyrus ACMI). Probe is available in both 1.9- and 3-French sizes and fits through working channel of either 9- or 16.5-French flexible endoscope.
Fig. 2D —Tools for interventional radiology–operated stone removal.
D, Photograph shows stone basket (ZeroTip, Boston Scientific). Basket is also available in both 1.9- and 3-French sizes to grasp various sizes of stones coaxially through endoscope.
Fig. 2E —Tools for interventional radiology–operated stone removal.
E, Photograph shows ultrasonic lithotripsy device (ShockPlus Se SPL-T, Olympus) (arrowhead) is connected either to wall suction or preferably to closed suction system (Neptune Surgical Waste Management System, Stryker) to provide combination of ultrasonic stone fragmentation and suction to quickly remove large stones.
Fig. 2F —Tools for interventional radiology–operated stone removal.
F, Photograph shows that fragmented gallstones can be seen within suction tubing during ultrasonic lithotripsy through rigid endoscope.
Fig. 3A —Endoscopic images of 65-year-old woman with small pigment gallstones (A–C) and 73-year-old woman (D–F) with large gallstones.
A, Gallstone is fragmented using 3-French electrohydraulic lithotripsy device through 16.5-French flexible endoscope.
Fig. 3B —Endoscopic images of 65-year-old woman with small pigment gallstones (A–C) and 73-year-old woman (D–F) with large gallstones.
B, Gallstone is fragmented using 3-French electrohydraulic lithotripsy device through 16.5-French flexible endoscope.
Fig. 3C —Endoscopic images of 65-year-old woman with small pigment gallstones (A–C) and 73-year-old woman (D–F) with large gallstones.
C, Gallstone is fragmented using 3-French electrohydraulic lithotripsy device through 16.5-French flexible endoscope.
Fig. 3D —Endoscopic images of 65-year-old woman with small pigment gallstones (A–C) and 73-year-old woman (D–F) with large gallstones.
D, Large gallstone is more quickly and easily treated with ultrasonic lithotripsy device through 22.5-French rigid endoscope. Large stones are more difficult and time-consuming to fully extract using electrohydraulic lithotripsy and stone baskets.
Fig. 3E —Endoscopic images of 65-year-old woman with small pigment gallstones (A–C) and 73-year-old woman (D–F) with large gallstones.
E, Large gallstone is more quickly and easily treated with ultrasonic lithotripsy device through 22.5-French rigid endoscope. Large stones are more difficult and time-consuming to fully extract using electrohydraulic lithotripsy and stone baskets.
Fig. 3F —Endoscopic images of 65-year-old woman with small pigment gallstones (A–C) and 73-year-old woman (D–F) with large gallstones.
F, Large gallstone is more quickly and easily treated with ultrasonic lithotripsy device through 22.5-French rigid endoscope. Large stones are more difficult and time-consuming to fully extract using electrohydraulic lithotripsy and stone baskets.
Fig. 4A —65-year-old woman with history of alcoholic cirrhosis and chronic cholecystitis with gallstone that intermittently obstructed gallbladder neck. Because she was not surgical candidate, chronic cholecystitis had been managed with long-term cholecystostomy for 8 months before cholecystoscopy.
A, Cholecystogram obtained through upsized 14-French cholecystostomy drain before cholecystostomy shows single stone floating within gallbladder lumen. After contrast injection, stone was noted to be freely mobile and intermittently obstructing cystic duct. Debris within gallbladder neck also obstructed cystic duct.
Fig. 4B —65-year-old woman with history of alcoholic cirrhosis and chronic cholecystitis with gallstone that intermittently obstructed gallbladder neck. Because she was not surgical candidate, chronic cholecystitis had been managed with long-term cholecystostomy for 8 months before cholecystoscopy.
B, Cholecystoscopy was performed using 16.5-French flexible endoscope. Endoscopic image shows successful capture of gallstone using stone basket (ZeroTip, Boston Scientific).
Fig. 4C —65-year-old woman with history of alcoholic cirrhosis and chronic cholecystitis with gallstone that intermittently obstructed gallbladder neck. Because she was not surgical candidate, chronic cholecystitis had been managed with long-term cholecystostomy for 8 months before cholecystoscopy.
C, Photograph shows gallstone that was removed.
Fig. 4D —65-year-old woman with history of alcoholic cirrhosis and chronic cholecystitis with gallstone that intermittently obstructed gallbladder neck. Because she was not surgical candidate, chronic cholecystitis had been managed with long-term cholecystostomy for 8 months before cholecystoscopy.
D, Cholecystogram obtained 8 weeks after A–C after tube was downsized shows no filling defects within gallbladder, patent cystic duct, and free flow into small bowel; tube was subsequently removed and patient was well 5 months after removal.
Fig. 5A —73-year-old woman with history of small cell lung cancer who was undergoing chemotherapy. Patient underwent cholecystostomy tube placement after she developed acute cholecystitis. Cholecystitis was managed with long-term cholecystostomy tube for 8 months before cholecystoscopy because she was not deemed to be surgical candidate.
A, CT image shows three gallstones within gallbladder lumen (arrow) and gallstone within gallbladder neck (arrowhead).
Fig. 5B —73-year-old woman with history of small cell lung cancer who was undergoing chemotherapy. Patient underwent cholecystostomy tube placement after she developed acute cholecystitis. Cholecystitis was managed with long-term cholecystostomy tube for 8 months before cholecystoscopy because she was not deemed to be surgical candidate.
B, Cholecystogram shows same findings seen in A including three large gallstones (arrowheads) within gallbladder lumen and obstructed cystic duct. Partially visualized is migrated double-J stent extending from cystic duct to small bowel.
Fig. 5C —73-year-old woman with history of small cell lung cancer who was undergoing chemotherapy. Patient underwent cholecystostomy tube placement after she developed acute cholecystitis. Cholecystitis was managed with long-term cholecystostomy tube for 8 months before cholecystoscopy because she was not deemed to be surgical candidate.
C, Cholecystogram shows rigid 22.5-French endoscope through 24-French Teflon sheath with grasping forceps (arrow) used to grasp samples of stone for culture. Ultrasonic lithotripter was also used to fragment and suction out large stone fragments to achieve complete stone extraction. Original access site (sheath tip, arrowhead) entered antrum of gallbladder and was not suitable for cholecystoscopy with rigid endoscope.
Fig. 5D —73-year-old woman with history of small cell lung cancer who was undergoing chemotherapy. Patient underwent cholecystostomy tube placement after she developed acute cholecystitis. Cholecystitis was managed with long-term cholecystostomy tube for 8 months before cholecystoscopy because she was not deemed to be surgical candidate.
D, Cholecystogram obtained 8 weeks after A–C and after tube was downsized shows no filling defects in gallbladder and widely patent cystic duct and common bile duct. Tube was removed, and patient was well 3 months after removal.
Fig. 5E —73-year-old woman with history of small cell lung cancer who was undergoing chemotherapy. Patient underwent cholecystostomy tube placement after she developed acute cholecystitis. Cholecystitis was managed with long-term cholecystostomy tube for 8 months before cholecystoscopy because she was not deemed to be surgical candidate.
E, Patient underwent CT for restaging of lung cancer 10 weeks after tube removal. CT image shows gallbladder (arrow) and biliary tree to be free of abnormalities.
On completion of cholecystoscopy and stone removal, all patients received transcystic internal and external drainage catheters from the access tract through the gallbladder and into the small bowel. Transcystic drainage catheters (Biliary Drainage, Cook Medical) were 8.5–14-French depending on operator preference and were placed to help any remaining debris pass from the gallbladder into the duodenum as well as to keep the cystic duct patent in case of postoperative edema. Patients also received cholecystostomy catheters. Cholecystostomy catheters (Dawson-Mueller or Multipurpose Drain) were 7- to 20-French depending on operator preference. All patients were admitted to the hospital overnight for monitoring in a medical short stay unit and were discharged the next day with a 7- to 10-day supply of amoxicillin and clavulanate (Augmentin, GlaxoSmithKline).
Patients returned for evaluation within 2 weeks of cholecystoscopy and stone removal, at which point the transcystic drainage catheters were removed and the cholecystostomy catheters were downsized to 7-French (Dawson-Mueller Drain, Cook Medical). The cholecystostomy catheters were removed at a visit 2 weeks later, which was 4 weeks after cholecystoscopy. Patients received ursodeoxycholic acid for at least 6 months after the final procedure.

Outcomes

The time between cholecystostomy and cholecystoscopy was defined in days. Primary technical success of cholecystoscopy and stone removal was defined as fragmentation and removal of all stones after the first cholecystoscopy procedure; secondary technical success was defined as removal of all stones after repeat procedures. Technical success and removal of all stones were confirmed by endoscopic evaluation. Procedure and fluoroscopy times were recorded in minutes. The time between cholecystoscopy and cholecystostomy removal was recorded in days. Complications were categorized by the “Quality Improvement Guidelines for the Reporting and Archiving of Interventional Radiology Procedures” [15]. The follow-up period was measured in days.

Follow-Up

All patients were monitored for cholecystostomy removal, recurrent symptomatic acute calculous cholecystitis, or death during follow-up visits and via retrospective review of the electronic medical record (EPIC).

Statistical Analysis

Calculations of percentages, means, and ranges were performed on the data using spreadsheet software (Excel 2017).

Results

Eleven (85%) patients had initial transhepatic and two (15%) had initial transperitoneal cholecystostomy. Two (15%) patients required additional cholecystostomy for cholelithiasis removal. One (8%) patient required a second gallbladder access because of restricted endoscope mobility and an inability to achieve complete stone removal. One (8%) patient required additional cholecystostomy placement because of large gallstone burden. Additional cholecystostomy was performed 51 days after the original cholecystostomy in one patient after and 89 days in a second patient. The mean time from cholecystostomy to cholecystoscopy was 151 days (range, 11–321 days).
All cholecystoscopy procedures were performed by interventional radiologists. Eleven (85%) patients required a single cholecystoscopy procedure, one (8%) patient required two procedures, and one (8%) patient required three procedures. Both patients requiring more than one procedure had too many calculi to remove in a single session; removal was limited by large volumes of fluid instilled during each single procedure. The second follow-up procedures were performed at 120 and 186 days after the first; the lag between the procedures was because of difficulty scheduling secondary to management of other medical comorbidities. Follow-up procedures, however, may be performed as early as 1–2 weeks after the initial procedure.
Flexible endoscopy (URF-P6 and CYF-5) was used in eight (62%) patients, rigid endoscopy (WA33036A) in three (23%), and both flexible and rigid endoscopy in two (15%). Electrohydraulic lithotripsy (REF-1F or REF-3F) was used in eight, nitinol stone retrieval baskets (ZeroTip) in seven, ultrasonic lithotripsy (ShockPlus SE SPL-T) in two, and percutaneous thrombectomy devices (Arrow Trerotola) in one. Primary technical success was achieved in 11 (85%) patients, and secondary technical success was achieved in 13 (100%) patients. No (0%) patients were noted to have an incidental gallbladder mass or malignancy during endoscopic evaluation. The mean procedure time was 164 minutes (range, 51–272 minutes). The mean fluoroscopy time was 30 minutes (range, 6–67 minutes).
No (0%) minor and two (15%) major complications occurred according to the “Quality Improvement Guidelines for the Reporting and Archiving of Interventional Radiology Procedures” [15]. One (8%) patient developed acute pancreatitis 4 days after the procedure, which was managed medically but was complicated by an exacerbation of congestive heart failure and the patient was hospitalized for 32 days. One (8%) patient underwent three separate cholecystoscopy procedures and was admitted to the hospital 7 days after the final procedure with pneumonia and sepsis. This patient developed gastrointestinal hemorrhage secondary to venous thromboembolism prophylaxis and died 12 days after the procedure.
The mean and median hospital lengths of stay after cholecystoscopy and stone removal were 4 days (range, 1–32 days) and 1 day, respectively. Nine (69%) patients were discharged 1 day after cholecystoscopy and stone removal. One (8%) patient remained hospitalized for 2 days because of low oxygen saturation values in the setting of chronic obstructive pulmonary disease. One (8%) patient remained hospitalized for 5 days because of incidentally noted atrial fibrillation after the procedure. One (8%) patient developed acute pancreatitis and remained hospitalized for 32 days for acute pancreatitis and congestive heart failure. One (8%) patient underwent a second cholecystoscopy, remained hospitalized for 4 days, underwent a third cholecystoscopy, and was discharged from the hospital.
Cholecystostomy drains were removed in all (100%) patients. The mean time between cholecystoscopy and cholecystostomy removal was 39 days (range, 5–112 days). The follow-up period ranged from 12 to 1825 days, and follow-up was performed via a single clinic visit and then chart review for recurrent episodes of symptomatic cholelithiasis. One (8%) patient developed recurrent acute calculous cholecystitis 1095 days after cholecystoscopy and underwent cholecystectomy.

Discussion

The results of this study show that interventional radiology–operated cholecystoscopy with stone removal may serve as an effective technique to render nonsurgical candidates with symptomatic stone disease cholecystostomy-free with a low recurrence rate of acute calculous cholecystitis. The results of the current study show high primary and secondary technical success with fragmentation and ultimate removal of gallstones in all 13 (100%) patients. Moreover, cholecystostomy drains were removed in all (100%) patients. Only one (8%) patient developed recurrent acute calculous cholecystitis, which occurred 1095 days after cholecystoscopy.
Interventional radiology–guided choledochoscopy, or cholangioscopy, has been described for the treatment of symptomatic intrahepatic and extrahepatic choledocholithiasis in the setting of failed ERCP [16]. The principles and skills required for cholecystoscopy are similar to those of choledochoscopy [1618]. One major difference, however, is that choledochoscopy is performed when perioral endoscopic methods have failed. Every patient who receives cholecystostomy drainage, on the other hand, is a potential patient who may benefit from cholecystoscopy and stone removal.
The largest single-study cholecystoscopy experience to date was reported by Ohashi [13] and included 53 patients over a 7-year period. These patients were average-risk, not high-risk, patients who underwent cholecystoscopy within 1–2 weeks after initial cholecystostomy placement for acute calculous cholecystitis [13]. Ohashi reported a 96% technical success rate with a low cholelithiasis recurrence rate of 2.5%, similar to the 8% recurrence rate reported in our study. The study by Ohashi was performed at the dawn of modern lithotripsy technologies and at a time when cholecystostomy drainage had not gained significant traction for the treatment of acute cholecystitis. Two later studies focused specifically on high-risk and elderly patients with acute cholecystitis who received cholecystostomy placement [5, 19]. Both of these studies showed 100% technical success, concordant with our current study, but lacked long-term follow-up evaluation. In a study of high-risk patients, Kim et al. [20] reported a 15% complication rate, which is concordant with our complications. They also described percutaneous cholecystoscopy for the treatment of symptomatic cholelithiasis, but the operators were not interventional radiologists [20]. Gillams et al. [21] reported a median hospital length of stay of 18 days, which is significantly longer than our median of 1 day. To our knowledge, our study is the only one with entirely interventional radiology–operated cholecystoscopy to report the technical success, hospital length of stay, time between cholecystoscopy and cholecystostomy removal, and long-term recurrence of acute calculous cholecystitis in high-risk patients who were unable to undergo open or laparoscopic cholecystectomy.
There are three notable differences between prior studies and our current study. All cholecystoscopy and stone removal procedures were performed entirely by interventional radiologists in our experience. Patients in the prior studies were specifically identified to be treated with cholecystostomy and subsequent cholecystoscopy [13, 20]. Thus, these patients underwent cholecystostomy, tract dilatation, cholecystoscopy, and drain removal within 30–45 days. Our patients were treated in the acute setting with plans for surgery but were later deemed not to be surgical candidates and therefore were treated with long-term cholecystostomy. Although the mean dwell time for cholecystostomy catheters in this study was long at 151 days (range, 11–321 days), there were delays before decisions were made to perform cholecystoscopy and cholelithiasis removal for definitive management. Factors leading to a delay included delayed multidisciplinary discussions, a limited number of operators who perform cholecystoscopy, decision making regarding this understudied procedure, and lack of knowledge of cholecystoscopy and stone removal as a definitive treatment of acute calculous cholecystitis. It is likely that as interventional radiologists assume a greater role in longitudinal patient care and cholecystoscopy becomes more widely practiced, more patients will undergo cholecystoscopy and stone removal for the management of symptomatic cholecystitis. The third notable difference is that 6–11% of patients in previous studies had an incidental gallbladder carcinoma diagnosed at endoscopic evaluation [13, 19]; however, no patients in our study were found to have a gallbladder malignancy. The possibility of gallbladder malignancy highlights the importance of a thorough and complete endoscopic examination of the gallbladder mucosa including obtaining biopsy samples as necessary. Many of the prior studies were conducted 20 years or more before our study. Perhaps imaging advancements have resulted in more accurate diagnosis of gallbladder carcinoma and hence none was identified in our study.
The results of the interventional radiology–operated procedures in our study compare favorably to noninterventional radiology–guided procedures for the treatment of symptomatic stone disease. Studies of elective laparoscopic cholecystectomy in elderly patients with multiple comorbidities suggest that most patients have a length of hospital stay of 2 days [22]. When we exclude the one patient with a prolonged hospital stay of 32 days due to acute pancreatitis, the average length of hospital stay in our study was 2 days. Major complication rates in the elderly population after laparoscopic cholecystectomy range from 12% to 17% [23, 24], which is similar to the 15% complication rate found in this study. There is a reported 0.4% mortality from laparoscopic cholecystectomy [22]. The sole death in this study occurred in a patient as a result of aspiration, sepsis, and gastrointestinal hemorrhage from venous thromboembolism prophylaxis. The death of this patient was not a direct result of cholecystoscopy and stone removal.
Our results also compare favorably to medical therapy for symptomatic cholelithiasis. Treatment with ursodeoxycholic acid alone results in a 50% cholelithiasis recurrence and symptom relief may take 6–24 months [25]. Direct contact solvents are experimental and have an even greater rate of recurrence of 70% as well as low rates of duodenitis, hemolysis, and nephrotoxicity [24]. Extracorporeal shock wave lithotripsy results in 70% recurrence, requires local expertise, and may be used only in patients with a proven patent cystic duct and an otherwise functioning gallbladder because the fragments cannot otherwise be expelled [24].
This study aims to equip and inspire interventional radiologists to expand their involvement in the longitudinal clinical management of patients with symptomatic cholelithiasis. The staggering increase in numbers of cholecystostomy referrals has created a large patient population who may benefit from cholecystoscopy and stone removal [14]. Low-profile endoscopes and advancing lithotripsy technologies may easily be added to the inventories of interventional radiology departments. As interventional radiologists become more clinically focused, operators may embrace the opportunity to render their patients cholecystostomy-free by offering definitive treatment of symptomatic cholelithiasis via cholecystoscopy and stone removal.
There are limitations to this study. This study was a retrospective study without a control group; hence, comparison with long-term percutaneous cholecystostomy or cholecystectomy was not performed. Additional limitations include the small number of patients and variability of approaches and procedures. Further studies of cholecystoscopy procedures performed by interventional radiologists are needed.

Conclusion

Percutaneous cholecystostomy with interventional radiology–operated cholecystoscopy and stone removal may serve as an effective method for the management of symptomatic cholelithiasis in patients with multiple comorbidities with high technical success, few complications, short hospital length of stay, and few cholecystitis recurrences.

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Information & Authors

Information

Published In

American Journal of Roentgenology
Pages: 1164 - 1171
PubMed: 29547060

History

Submitted: June 29, 2017
Accepted: August 23, 2017
Version of record online: March 16, 2018

Keywords

  1. acute calculous cholecystitis
  2. cholecystoscopy
  3. choledochoscopy
  4. cholelithiasis
  5. endoscopy
  6. gallstones
  7. interventional radiology
  8. percutaneous stone removal

Authors

Affiliations

Nishant Patel
Department of Radiology, Division of Vascular and Interventional Radiology, University of Michigan Health System, Michigan Medicine, 1500 E Medical Center Dr, Ann Arbor, MI 48109.
Jeffrey Forris Beecham Chick
Department of Radiology, Division of Vascular and Interventional Radiology, University of Michigan Health System, Michigan Medicine, 1500 E Medical Center Dr, Ann Arbor, MI 48109.
Joseph J. Gemmete
Department of Radiology, Division of Vascular and Interventional Radiology, University of Michigan Health System, Michigan Medicine, 1500 E Medical Center Dr, Ann Arbor, MI 48109.
Jordan C. Castle
Department of Radiology, Division of Vascular and Interventional Radiology, University of Michigan Health System, Michigan Medicine, 1500 E Medical Center Dr, Ann Arbor, MI 48109.
Narasimham Dasika
Department of Radiology, Division of Vascular and Interventional Radiology, University of Michigan Health System, Michigan Medicine, 1500 E Medical Center Dr, Ann Arbor, MI 48109.
Wael E. Saad
Department of Radiology, Division of Vascular and Interventional Radiology, University of Michigan Health System, Michigan Medicine, 1500 E Medical Center Dr, Ann Arbor, MI 48109.
Ravi N. Srinivasa
Department of Radiology, Division of Vascular and Interventional Radiology, University of Michigan Health System, Michigan Medicine, 1500 E Medical Center Dr, Ann Arbor, MI 48109.

Notes

Address correspondence to J. F. B. Chick ([email protected]).

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