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1
Department of Radiology, University Hospital Ghent, De Pintelaan 185, 9000
Ghent, Belgium.
2
Department of Radiology, Brigham and Women's Hospital, Harvard Medical School,
75 Francis St., Boston, MA 02115.
3
Department of Surgery, University Hospital Ghent, 9000 Ghent, Belgium.
Received September 28, 2000;
accepted after revision December 28, 2000.
Address correspondence to K. J.
Mortelé.
Abstract
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MATERIALS AND METHODS. We reviewed the radiologic findings in 218 consecutive morbidly obese patients after laparoscopic placement of the Swedish gastric banding system. Radiographic studies of the stomach (obtained with liquid barium sulfate suspension) were performed before surgery and 1 month after band placement in every patient. Additional studies in symptomatic patients were performed when needed.
RESULTS. Surgical complications found included misplacement of the band (five patients, 2.3%), slippage of the band (17 patients, 7.8%), and pouch enlargement (eight patients, 3.7%). Technical problems encountered were inversion of the access port (three patients, 1.4%), leakage of the device (two patients, 0.9%), and spontaneous decrease of the stoma size caused by gastritis (seven patients, 3.2%) or the hyperosmolar properties of the IV contrast material (12 patients, 5.5%). Intrinsic abnormalities of gastroesophageal tract seen included trapping of food in the stoma (four patients, 1.8%) and esophagitis (11 patients, 5%).
CONCLUSION. Although, according to the available data, the gastric banding operation with the Swedish band meets the criteria of a low-risk laparoscopic alternative treatment of morbid obesity, the radiologic appearances of various complications may be seen on the images of patients who have undergone the procedure. The radiologist plays a key role in the early detection of those complications and treatment of specific abnormalities.
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Two different gastric banding devices are currently being used in clinical practice. The radiologic appearance of the oldest and still most commonly used device, the laparoscopic adjustable silicone gastric banding (LAP-BAND Adjustable Gastric Banding System; BioEnterics, Carpinteria, CA), has been recently described [1,2,3,4,5]. The initial clinical experiences and possible complications with a newer device, the Swedish adjustable gastric banding (SAG-BAND; Obtech Medical, Baar, Switzerland), have also been reported [6, 7]. Nevertheless, we do not know of any report published on the spectrum of radiologic findings and the optimal technique for use of contrast material to evaluate this type of gastric banding device.
Therefore, the purpose of this report is to describe and illustrate the radiologic appearances of properly functioning Swedish gastric banding devices and the possible complications in a large group of patients and to delineate the role of the radiologist in adjusting the device, detecting postoperative complications, and conducting the follow-up of those patients.
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Before surgery, examinations were performed in all 218 consecutive patients, including laboratory tests such as hematologic profiles and endocrinologic tests, nutritional evaluations, and double-contrast upper gastrointestinal series. Psychiatric testing and gastroesophagoscopy were performed when indicated. All patients selected for surgery had a history of repeated failure with dietary regimens.
Surgical Procedure and Device
The surgical procedure of Swedish adjustable gastric banding consists of
laparoscopic looping of a nonradiopaque silicone band around the fundus of the
stomach, thereby creating a small proximal gastric pouch with a stoma to the
remainder of the stomach [8].
Additional seroserosal stitching of the stomach is performed anteriorly to
attach the band to the gastric wall (Fig.
1). The stoma size between the small upper pouch and the lower
portion of the stomach is adjustable because the inner surface of the band is
inflatable and connected by a thin silicone tube to a radiopaque access port
with a self-sealing membrane. During the same surgical session, the access
port is sutured in the anterior rectus sheath, typically below the caudal part
of the left rib cage (Fig.
2).
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Adjustment Technique
The device contains an inflatable inner surface that allows adjustment of
the stoma size by puncturing the access port percutaneously and injecting or
withdrawing fluid solution. Up to 8 mL of fluid solution can be injected
before a complete closure of the Swedish band is obtained. Because stomal
edema in the early postoperative period may temporarily decrease stoma size,
the band is left empty at surgery.
We performed the earliest initial band adjustment at 3-4 weeks after surgery. After this first adjustment, additional sessions were scheduled depending on the patient's ability to eat, weight loss curve, or manifestation of complications. The diagnosis of complications was based on clinical parameters, such as persistent vomiting, gastroesophageal reflux, dysphagia, or odynophagia.
In our experience, optimal stoma size adjustment was best performed under fluoroscopic guidance in seven steps: (1) fluoroscopic examination of the whole gastric banding system to evaluate adequate positioning of the band and access port and to detect possible technical complications; (2) limited single-contrast upper gastrointestinal study with liquid barium sulfate suspension to judge the actual stoma size, volume of the upper gastric pouch, and passage rate of the barium suspension and to detect intrinsic abnormalities of the gastrointestinal tract (Fig. 3A); (3) fluoroscopic localization of the access port followed by aseptic cleaning of the skin; (4) puncture of the access port during fluoroscopic guidance using a special noncoring deflected tip (Huber tip) needle; (5) fluoroscopically guided injection or withdrawal of nonionic, isoosmolar contrast material (Visipaque 270 mg/dL; Nycomed-Amersham, Oslo, Norway) depending on the stoma size; and (6) evaluation of stoma size after adjustment with barium suspension (with the needle still in the access port, Fig. 3B). At this point, additional injection or withdrawal of contrast material might be indicated to adjust the stoma to the optimal size for the individual patient. In our study, the parameters used to determine optimal stoma size were the rate of passage of barium through the stoma, grade of retrograde filling of the upper gastric pouch, and presence or absence of gastroesophageal reflux. The seventh and final step was the removal of the needle.
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All adjustments were performed with the patient in the anteroposterior position when technically possible. If the gastric fundus, filled with barium, was obscuring the stoma after the initial upper gastrointestinal series, the patient was moved to a slightly right posterior oblique position. All adjustments were made in 5-10 min.
Optimal adjustment of the stoma was generally achieved in two to three sessions. During the first adjustment, 4-5 mL of contrast material was injected, which caused a significant decrease in stoma size. Thereafter, if no complications occurred, only one to two additional sessions with the injection of 1-2 mL of contrast medium were necessary to achieve optimal adjustment of the band. The time interval between these sessions and the amount of added fluid in each session were extremely variable and determined individually for each patient.
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Surgical Complications
Misplacement of the band.—Of 218 patients, 213 (97.7%) were
found to have correctly positioned bands without complications at the 1-month
postoperative upper gastrointestinal series. However, in two asymptomatic
patients, the band had not enclosed the stomach but only perigastric fat
(Fig. 4). Confirmation of this
complication was obtained at surgery. In three other patients, the band had
been initially misplaced around the lower part of the stomach, causing severe
gastric outlet obstruction (Fig.
5). These three patients presented with extensive vomiting during
the early postoperative period (
3 days after surgery). This complication,
unfortunately, was caused by lack of experience of one of the surgeons. All
five patients (2.3%) underwent a second operation to reposition the band.
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Slippage of the band.—We defined slippage as the herniation of stomach from below the band upward, resulting in pouch enlargement. Patients with this complication presented with clinical findings such as stabilization of weight loss, which was caused by the enlarged upper gastric pouch; severe gastroesophageal reflux, especially when in the supine position, because of delayed emptying of the pouch; and, in patients with severe cases of band slippage, stoma obstruction caused by dependent migration or rotation of the upper gastric pouch.
The characteristic radiographic image was that of an enlarged upper pouch (predominantly left sided and posterior), horizontal orientation of the band, presence of an air-fluid level in the pouch caused by the delayed emptying, and, in patients with severe band slippage, stoma obstruction.
In our series, slippage was detected in 17 patients (7.8%). Twelve of them (5.5%) presented with severe slippage complicated by acute stoma obstruction (Fig. 6). We obtained initial relief of symptoms by removing all contrast material from the band; an operation was required to reposition the device. In two of those patients, the withdrawal of contrast material did not improve stoma patency, and a second surgery was mandatory to relieve symptoms. In three patients, the slippage was moderate—without obstruction—and in two other patients, it was mild—without horizontal orientation of the band or presence of an air-fluid level) (Fig. 7A,7B).
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Both of the latter groups were treated conservatively. In those patients with mild to moderate slippage, the band was emptied, and fluoroscopic reevaluation was performed 4 weeks later. If the slippage had disappeared, a conservative approach was initiated with repetitive reinjection of contrast material at a slow rate. If the slippage was still present, no adjustment was performed until the herniation spontaneously resolved. In the three patients with moderate slippage, although the herniation recurred after the repetitive reinjection, the conservative approach—repeated emptying and reinflation—stabilized the weight curve sufficiently.
Pouch dilatation—We defined pouch dilatation as a significant enlargement of the upper gastric pouch (Fig. 8A). The main clinical manifestations of pouch dilatation are stabilization in the weight loss curve and gastroesophageal reflux disease. Pouch dilatation was present either in combination with band slippage or as a solitary finding. In our study, pouch dilatation as an only finding was detected in eight patients (3.7%). Its radiographic image is of an enlarged pouch with a correctly positioned band and normal stoma size. Pouch dilatation without slippage was treated conservatively in all patients by removing all the contrast material from the band and performing fluoroscopic reevaluation 4-6 weeks later. If the pouch appeared to be normal size, the band was reinflated slowly over the course of several sessions (Fig. 8B).
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Technical Complications
Rotation and inversion of the injection port.—In patients
whose ports had rotated in an upright position, derotation was frequently
achievable by positioning the patient in supine and oblique positions (Fig.
9A,9B).
Slightly rotated ports were best accessed by supportive manual compression,
most easily achieved with the patient in the supine position. In our study
population, three (1.4%) of 218 patients presented with a complete inversion
of the port, which could not be accessed for adjustment in any position. These
completely inverted ports had to be repositioned surgically with the patients
under local anesthesia.
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Leakage of the banding system.—In our series, leakage of contrast material during adjustment was detected radiographically in two patients (0.9%). One patient had leakage from the connecting tube (Fig. 10), and another had leakage from the band itself (Fig. 11). In both patients, the leakage was clinically suspected because neither patient noticed any change in the ability to eat after the initial inflation. Both patients had surgery so that the leaking part of the device could be exchanged for a functioning part.
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Spontaneous decrease of stoma size.— Spontaneous decrease of stoma size was caused by either gastric inflammation with mucosal thickening (seven patients) or spontaneous diffusion of fluid into the gastric band due to the presence of hyperosmolar contrast material in the band (12 patients). Patients whose decreased stoma size had been caused by gastric inflammation with mucosal thickening typically presented with moderate dysphagia and epigastric pain. A combined approach of partially emptying of the band (for 4 weeks) and orally administrating H2-receptor blockers ([800 mg of cimetidine daily], Tagamet; SmithKline Beecham Pharmaceuticals, Crawley, UK) was preferred.
In our study population, spontaneous decrease of stoma size due to diffusion of fluid into the gastric band was caused the hyperosmolar contrast medium (Urografine 60%; Schering, Berlin, Germany) used to make initial adjustments. In those patients, various clinical manifestations were found. Seven patients presented with mild dysphagia or increased weight loss due to the decreased stoma size, although their banding systems were morphologically normal. In these patients, the hyperosmolar contrast medium was completely removed and replaced with an appropriate amount of an isoosmolar contrast agent. However, in five of the patients, the diffusion of fluid into the band had resulted in complete closure of the stoma and complications such as pouch dilatation or slippage. In these patients, the band was deflated, and the patient was reexamined after 4 weeks. In two of those five patients presenting with severe slippage, another operation was required to relieve symptoms. We discontinued use of the hyperosmolar contrast medium in March 1999.
Intrinsic Abnormalities
Food trapping in the band.—Acute obstruction caused by food
being trapped in the stoma was seen in four patients (1.8%)
(Fig. 12). All of them
presented with acute dysphagia and odynophagia immediately after a meal. Acute
obstruction caused by food entrapped in the stoma was easily and rapidly
relieved by completely emptying the inner cuff and reinflating the band after
passage of the obstructing food elements.
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Esophagitis.—Radiologic signs of esophagitis, including fuzzy delineation of the esophageal wall and small erosions, were judged to be present in 11 patients (5%). When the radiologic diagnosis was confirmed at endoscopy, patients who were experiencing dysphagia or odynophagia and whose systems had been optimally adjusted were treated by oral administration of H2-receptor blockers (800 mg of cimetidine daily). In patients with both esophagitis and a severe gastroesophageal reflux or decreased stoma size, a combined approach of partially emptying the band for 4 weeks and orally administrating H2-receptor blockers was preferred.
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When comparing the LAP-BAND Adjustable Gastric Banding System with the Swedish gastric banding device, major differences are observed that have an impact on the radiologic appearance and incidence of complications: The volume of the inflatable cuff within the band is approximately twice as great in the Swedish device as in the LAP-BAND (8 mL versus 4 mL); the height of the Swedish band is greater than the LAP-BAND (2 cm versus 1 cm); and the Swedish band is not visible fluoroscopically and, therefore, requires the use of contrast material to evaluate positioning of the band. Because the volume of the inflatable cuff of the Swedish band is much greater, minimal adjustments can be performed more precisely, and the injection of small amounts of contrast medium does not cause the major change in the diameter of the stoma that is described with the LAP-BAND [1, 2]. Furthermore, because of its larger volume and height, the Swedish band should behave as a lower pressure system and therefore be less likely to cause erosion or migration.
Indeed, unlike reported problems with the LAP-BAND, no erosion of the Swedish band was detected in our patients. Moreover, the most common complication in our series, slippage of the band, was present in 17 patients (7.8%). In only 5.5% of patients, however, did the slippage require a second operation. By contrast, in reporting the findings with the LAP-BAND in 23 patients, Szucs et al. [2] described an incidence of slippage resulting in additional surgery in 8.6% of patients. In the study by Hainaux et al. [1] involving 180 patients, there were 15 patients (8.3%) who had band slippage with stoma obstruction that required surgery. With the exception of the high- versus low-pressure system hypothesis, causative mechanisms by which this complication occurs are still unclear. Other suggested causes, such as insufficient seroserosal stitching, overeating, extensive vomiting, or overfilling of the band, need to be examined to determine their specific roles.
Enlargement of the upper gastric pouch without slippage, which was detected in 3.6% of our patients, is believed to result directly from an inappropriate surgical technique [5]. To avoid the development of this complication, it is important for the surgeon to realize that the volume of the pouch created before surgery may increase as much as sevenfold during the first 2-3 years after the operation [13]. Deflation of the band for 4-6 weeks followed by repetitive injection of contrast medium at a slow rate resolved the dilatation in all patients and, therefore, in our experience, solitary pouch enlargement can be treated conservatively.
The use of isoosmolar contrast material for opacification and evaluation of the Swedish band system revealed several advantages over the use of the saline used in other series [1, 2]. First, incorrect placement of the band, found in five of our patients, was diagnosed accurately and quickly. Second, osmotic-based leakage of the gastric banding system, expected with saline injection because of the semipermeability of the inflatable cuff, was completely eliminated. Third, direct leakage of the banding system, believed to result from either the silicone tube being punctured close to the port, poor handling of the inflatable balloon during surgery, or damage to the self-sealing membrane of the port caused by the use of inappropriate needles, was accurately depicted on fluoroscopy because of the contrast medium spillage.
One temporary disadvantage of the use of contrast medium in our series was the spontaneous decrease in the diameter of the stoma caused by the hyperosmolar material within the inflatable cuff. However, since March 1999, when we began using an isoosmolar contrast medium for band adjustments, no new cases of spontaneous decrease of stoma size were detected. Therefore, to prevent diffusion of fluid in or out of the band, we highly recommend the use of nonionic isoosmolar contrast material.
In comparing the incidence of technical complications in our series with those in previous reports on the LAP-BAND [1, 2], we find that our results are comparable or more promising. Direct leakage of the banding system, present in only 0.9% of our patients, was reported by Hainaux et al. [1] in 2.7% of patients. Furthermore, they mentioned the presence of leakage caused by the disconnection of the connection port in four (2.2%) additional patients, a complication not seen in our series. The number of our patients (1.4%) presenting with a completely inverted port is comparable with those previously reported with the LAP-BAND. In the series of Hainaux et al., three ports of 180 patients (1.6%) were impossible to access.
In conclusion, this study suggests that, according to the available data, the SAG-BAND procedure meets the criteria of a low-risk laparoscopic alternative in the treatment of morbid obesity. Nevertheless, various complications may be detected on follow-up imaging studies. Because early detection and therapeutic intervention may be crucial, the radiologist should be aware of these possible complications and their radiologic appearances. The radiologist also plays an important role in the treatment and follow-up of these patients. Therefore, for the patient to obtain optimal benefit from the procedure, the radiologist should be familiar with the adequate adjustment methods and should know the techniques for coping with the potential technical difficulties.
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