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Clinical Observations |
1 All authors: Department of Radiology, University of Ulsan College of Medicine, Asan Medical Center, 388-1, Poongnap-dong, Songpa-gu, Seoul, South Korea.
Received July 26, 2005;
accepted after revision September 18, 2005.
Address correspondence to J. H. Shin
(jhshin{at}amc.seoul.kr).
Abstract
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CONCLUSION. Fluoroscopically guided balloon dilation is effective and safe and has encouraging long-term results in the management of benign anastomotic strictures after total gastrectomy.
Keywords: fluoroscopy • gastrectomy • interventional radiology • stomach
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Data from follow-up for more than 1 year after balloon dilation, or after the first session in the cases of two or more sessions, were obtained for 23 of the 29 patients. Six patients were lost to follow-up or had died of recurrence of gastric cancer within 1 year of dilation and were therefore excluded. The mean follow-up period was 27.5 months (range, 12.1-102.2 months) for the 23 patients included in this study. The 14 men and nine women had an average age of 59.3 years (range, 44-76 years) and had undergone total gastrectomy with classic esophagojejunostomy (n = 20) or Roux-en-Y esophagojejunostomy (n =3) for advanced gastric cancer.
Anastomotic strictures were detected 14-388 days (mean, 100.8 days) after surgery. Stricture was diagnosed as benign postoperative stricture at endoscopy and on CT before balloon dilation. All the patients had normal CT findings before balloon dilation. The sites of anastomotic stricture were classic esophagojejunostomy (n = 20) and an anastomotic site (n = 2) and the proximal efferent jejunal loop (n = 1) in cases of Roux-en-Y esophagojejunostomy. The main symptoms were vomiting and dysphagia. Esophagography and endoscopy were performed within 2 weeks before balloon dilation to confirm the degree and location of the stricture. None of the 23 patients had a history of other management of anastomotic stricture, such as endoscopic dilation or bougienage. At our institution, endoscopic dilation and bougienage are not performed for anastomotic stricture.
Balloon Dilation Technique
Informed consent was obtained from all patients at the time of the
procedure. Balloon dilation was performed by two interventional radiologists
who had more than 7 years of experience using this technique. Before the
procedure, topical anesthesia of the pharynx was routinely achieved with an
aerosol spray of lidocaine hydrochloride (Litaine Inj, Dai Han). Neither a
sedative nor general anesthesia was used.
Under fluoroscopic guidance, a 0.035-inch exchange guidewire (Radiofocus Guide Wire M, Terumo) was inserted through the patient's mouth and passed through the anastomosis. When negotiation of the guidewire through the stricture was difficult because of nearly complete or complete obstruction due to the anastomotic stricture, a conventional vascular catheter or multifunctional coil catheter (Song-Lim, S & G Biotec) [3] was used to negotiate the guidewire across the stricture. Water-soluble contrast medium (iopromide, Ultravist 300, Schering Korea) was then injected through the graduated sizing angiographic catheter (Royal Flush II, Cook) or multifunctional coil catheter for opacification of the anastomosis itself and the proximal and distal parts of the anastomosis and for evaluation of the severity and length of the stricture. Between May 1996 and August 2000, we used a conventional vascular catheter with a curved tip and graduated sizing (n =3). After September 2000, we used a multifunctional coil catheter (n = 20).
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The diameter of balloon catheter chosen was based on the severity of the stricture. In most instances, a 15- to 20-mm balloon was initially used because of the severity of the stricture on esophagography within 2 weeks before balloon dilation. If assessment of the severity of the stricture was un-available or insufficient on preprocedural esophagography, as occurred in four cases, the severity of the stricture was determined with a graduated sizing catheter or multifunctional coil catheter during balloon dilation. If dilation with the first balloon catheter was easily accomplished and the patient tolerated the procedure well, the caliber of the balloon catheter was gradually increased up to 25 mm on the same day. Immediately after balloon dilation, the patients swallowed a small amount of water-soluble contrast medium for evaluation of the presence of esophageal rupture. If there was no evidence of stricture, esophagography was performed while the patient had a mouthful of barium.
Follow-Up and Study End Point
All patients underwent esophagography 1 month after balloon dilation for
verification of the status of the stricture and the presence of passage
disturbance. Additional follow-up esophagography was performed only on
patients with recurrent symptoms. If a patient had no difficulty swallowing
solid food, further dilation was not performed. If a patient experienced
dysphagia or if no improvement was found on follow-up esophagography, balloon
dilation was repeated. Final clinical information was later obtained by means
of telephone interviews with 13 patients and by the patient's physician in all
23 cases to determine the long-term clinical results.
Technical success was defined as a more than twofold increase in the diameter of the narrowed lumen without major complications such as esophageal perforation. Clinical success was defined as relief of dysphagia and good contrast passage on 1-month follow-up esophagography. Relief of dysphagia was defined as a decrease of more than one grade in dysphagia score 1 month after balloon dilation. To evaluate the degree of relief of dysphagia before and after balloon dilation, we used a dysphagia score similar to that used for patients with malignant dysphagia [4]. A score of 1 denoted ability to eat solid food; 2, ability to eat soft food; 3, ability to swallow liquids only; 4, no oral intake, no vomiting; 5, no oral intake, vomiting. Dysphagia scores before and 1 month after the first or only session of balloon dilation were compared by use of Wilcoxon's signed rank test with SPSS software (version 10.1, SPSS); p < 0.05 was considered statistically significant.
If two or more sessions of balloon dilation were needed, overall clinical success was determined from the final session of balloon dilation. In these patients with overall clinical success, a dysphagia-progression-free period was defined as the time from final balloon dilation to recurrence of dysphagia and was calculated according to the Kaplan-Meier method with SPSS. Death without recurrence of dysphagia and loss to follow-up were considered censored data (data in which the period of observation ended before the event of interest occurred). Recurrence of dysphagia was defined as reappearance of symptoms of dysphagia.
According to the Society of Interventional Radiology reporting standards, we defined major complications as those necessitating further treatment or hospitalization and minor complications as those that resolved spontaneously or with conservative treatment [5]. If there were esophageal ruptures, we classified them into three types: type 1, intramural; type 2, transmural without mediastinal leakage; type 3, transmural with mediastinal leakage [6].
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Clinical success was achieved in 18 (78%) of the 23 patients after one session of balloon dilation. As of the end of the follow-up period (range, 12.1-102.2 months; mean, 27.5 months) these patients had not experienced symptomatic recurrence. The other five patients experienced recurrent dysphagia during the follow-up period, and recurrent stricture was found on follow-up esophagography in all of them. These patients underwent further balloon dilation, stent placement, or both. The time interval between the first and second balloon dilations ranged from 5 to 293 days (mean, 95.8 days).
Three of the five patients with recurrent dysphagia (patients 19-21) reported the recurrence within 6 weeks after the first balloon dilation. These patients underwent successful second dilation, in which a 20-mm balloon catheter was used, 5-54 days after the first procedure and did not experience additional dysphagia by the end of the follow-up period. Two patients (patients 22 and 23) underwent a third balloon dilation, in which a 20- or 25-mm diameter balloon catheter was used, because of recurrent dysphagia even after a second session of dilation, in which a 20-mm balloon had been used. One of these two patients (patient 22) underwent placement of a polyurethane-covered retrievable expandable nitinol stent at the anastomotic site of Roux-en-Y esophagojejunostomy 9 days after the third balloon dilation because dysphagia had recurred, even after the third dilation, which had been performed with a 25-mm diameter balloon catheter. However, the stent migrated distally 1 week after placement and was immediately removed with a retrievable hook. This patient had progressive dysphagia due to recurrent narrowing of the anastomosis. Patient 23 had aggravated dysphagia and little improvement of the stricture on 1-month follow-up esophagography even after a third dilation, in which a 25-mm diameter balloon catheter was used. This patient reported intermittent dysphagia for 1 year after the final balloon dilation but did not undergo further treatment.
One month after balloon dilation, dysphagia scores were 1 in 16, 2 in four, and 3 in three patients (Table 1). Initial dysphagia scores were 1 in five, 2 in three, 3 in 11, and 5 in four patients. The five patients with an initial dysphagia score of 1 underwent balloon dilation because it was taking them more than 1 hour to eat solid food. When the dysphagia scores before and after dilation were compared, the median dysphagia score improved from 3 to 1, and statistically significant improvement in overall scores was seen (Wilcoxon's signed rank test, p <0.01). Overall clinical success was achieved in 21 patients (91%, 21/23) after one (n = 18) or two (n = 3) balloon dilations. In the 21 patients in whom overall clinical success was achieved, the mean dysphagia-progression-free period was 92.3 weeks (95% CI, 79.3-105.2).
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No treatment-related deaths or major complications occurred in this series. Type 1 esophageal rupture occurred in one (4%) of the patients (patient 8) during the first session of balloon dilation, in which a 20-mm-diameter balloon catheter was used (Fig. 2A, 2B). This complication was managed conservatively with fasting and antibiotics. Follow-up esophagography showed a healed intramural tear with improved luminal diameter.
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Although development of a stricture after total gastrectomy is disruptive to the patient's quality of life, treatment is relatively straight-forward. Fluoroscopically guided balloon dilation is safe and successful management of benign anastomotic stricture after total gastrectomy. This study shows the long-term follow-up results of benign anastomotic strictures after total gastrectomy managed with fluoroscopically guided balloon dilation in what is to our knowledge the largest population to date. Overall clinical success was achieved without major complications in 91% of the patients after a mean of 1.3 sessions. Furthermore, most of the patients with overall clinical success needed only a single dilation, and no patients needed surgical correction.
Endoscopically or fluoroscopically guided balloon dilation has been shown effective for benign gastrointestinal strictures of various causes. The success rate reported in the literature ranges from 83% to 100% [1, 2, 9, 10]. Our overall clinical success rate with fluoroscopic balloon dilation was 91%, which is comparable with the literature reports, although the definition of success rate is not consistent throughout the literature and populations are not identical.
Fluoroscopically guided balloon dilation has several advantages over endoscopically guided balloon dilation. First, we believe that fluoroscopic guidance facilitates negotiation of the guidewire and balloon catheter into irregular, long, tight strictures. Not only identification of the proximal and distal ends of the stricture but also visual control of the entire balloon catheter during placement is particularly important because the longitudinal axis of the anastomosis sometimes changes abruptly at the suture line, especially when an end-to-side anastomosis or a blind-ending pouch has been surgically created. Second, during balloon inflation, fluoroscopy enables immediate detection and correction of possible misplacement or incomplete dilation of the balloon catheter, which can be missed with endoscopy. Although the proximal end of a stricture can be directly visualized with endoscopy and the diagnosis can be confirmed with biopsy, the distal end of a stricture cannot be visualized with endoscopy. Interventional devices therefore are passed distally without visual control, and perforation by the tip of the balloon catheter can occur [7, 11].
Balloon dilation and bougienage are reported to necessitate repeated dilations. The median number of bougie dilations has been reported to range from three to 9.5 [12, 13], and the mean number of balloon dilations ranges from 2.8 to 6.6 [1, 2, 14]. In our study, a mean of only 1.3 dilation sessions were needed. Moreover, favorable long-term results were achieved. There are several explanations for the need for fewer sessions and for the encouraging long-term results. First, all study patients had strictures less than 1 cm long, and short strictures such as these respond better to balloon dilation than do long strictures [2]. Second, in most patients we used a balloon with a 20-mm diameter, which might have reduced the possibility of stricture recurrence. Our results suggest 20 mm is a desirable balloon size for achieving successful dilation of the anastomosis, providing the patient can tolerate such a large balloon. In previous studies, the maximal diameter of bougies ranged from 14 to 18 mm [13, 15, 16] and that of balloons from 15 to 20 mm [1, 2]. Third, under fluoroscopic guidance, we were able to fully inflate the catheter when the center of the balloon was in the center of the stricture, excluding the possibility of incomplete balloon dilation and balloon misplacement during dilation.
As an alternative to surgery, temporary placement of a retrievable expandable metallic stent can be effective for patients who show resistance to balloon dilation. Bae et al. [17] attempted temporary placement of a polytetrafluoroethylene-covered retrievable expandable nitinol stent for 2 months to manage a benign anastomotic duodenojejunal stricture refractory to repeated balloon dilations. They achieved favorable outcome without complications for 6 months after stent removal. The stent should be placed temporarily because rates of late complications caused by stent migration or formation of new strictures are considerably high [18, 19]. One patient in our study had a tight stricture refractory to repeated balloon dilations. We placed a covered retrievable expandable nitinol stent, but the stent migrated within 1 week after placement. Although early stent migration in this patient made it difficult to evaluate the efficacy of stent placement, we believe use of a covered retrievable expandable metallic stent should be considered in the care of selected patients with benign anastomotic stricture refractory to balloon dilation.
No major complications, such as massive bleeding or perforation, occurred in this study. Perforation has been reported in two of 114 patients treated with bougie dilation [13] and in one of 80 patients treated with endoscopy-guided balloon dilation [14]. Other studies in which no perforations were reported [1, 2, 12] included fewer than 40 patients. Wichern [20] emphasized that the single most important requirement for diagnosis of esophageal perforation is the physician's awareness of the patient's pain. As a minor complication, type 1 esophageal rupture, that is, intramural tear, occurred in only one patient and was treated conservatively.
In conclusion, fluoroscopically guided balloon dilation is effective and safe in the management of benign anastomotic stricture after total gastrectomy and has encouraging long-term results. A luminal diameter of 20 mm seems to be optimal for prevention of recurrent symptoms with the fewest complications.
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