Early Symptomatic Strictures after Gastric Surgery: Palliation with Balloon Dilation and Stent Placement

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1 Early Symptomatic Strictures after Gastric Surgery: Palliation with Balloon Dilation and Stent Placement Jin Hyoung Kim, MD, Ho-Young Song, MD, Sang Woo Park, MD, Chang Jin Yoon, MD, Ji Hoon Shin, MD, Jeong Hwan Yook, MD, Byung Sik Kim, MD PURPOSE: To evaluate the clinical efficacy and safety of balloon dilation and stent placement in the treatment of earl benign anastomotic strictures after gastric surgery. MATERIALS AND METHODS: From 1997 to 2006, 63 patients with early <3 months) ( benign anastomotic strictures after gastric surgery underwent fluoroscopic balloon dilation or stent placement due to obstructive symptoms. In all patients, balloon dilation was initially performed. Stent placement was indicated in patients who showed poor response to repeat balloon dilation. RESULTS: Balloon dilations were successfully performed in all 63 patients, with only three intramural tears. Thirty-one of the 63 patients (49%) showed good response to initial balloon dilation and required no further treatmen until the end of follow-up or death. Conversely, 32 patients (51%) had poor or no response or recurrence after initi balloon dilation and required multiple balloon dilations n ( 20), stent placement n ( 7), percutaneous gastrojejunostomy (n 2), and/or surgical revision n ( 3). At multivariate analysis, the anastomotic site was the only independent factor predictive of the response to balloon therapy P < (.001). During a mean follow-up of 12 months, overall clinical success was achieved in 56 of the 63 patients (89%) after a single balloon dilation n 31), ( multiple balloon dilations (n 20), and stent placement n ( 5). CONCLUSIONS: Balloon dilation is safe and effective for the treatment of patients with early benign anastomotic strictures after gastric surgery. Stent placement can be effective in selected patients with early benign anastomotic strictures refractory to balloon dilation. J Vasc Interv Radiol 2008; 19: ANASTOMOTIC strictures occur in lead to prolonged vomiting and nutri-consists deficiencies (4). Strictures can formed this study to evaluate the clin- of surgical revision. We per- 3% 13% of patients after gastric sur-tionagery (1 3), and these strictures can occur early or late after gastric sur-icagery. Early postoperative strictures are tion and stent placement in the efficacy and safety of balloon dila- usually secondary to edema or earlytreatment of early strictures after gastric surgery. From the Departments of Radiology (J.H.K., H.Y.S., scar formation (5). Benign postoperative strictures or strictures of the gas- J.H.S.) and Surgery (J.H.Y., B.S.K.), Asan Medical Center, University of Ulsan College of Medicine, 388-1, Poongnap-2dong, Songpa-gu, Seoul , tric outlet can be treated surgically ormaterials AND METHODS Republic of Korea; the Department of Radiology, with endoscopically or fluoroscopically guided balloon dilation 5 15). ( Patient Population Konkuk University Hospital, Seoul, Korea (S.W.P.); and the Department of Radiology, Seoul National This safe and effective modality is less University Bundang Hospital, Seoul National University College of Medicine, Seoul, Korea (C.J.Y.). expensive and requires less time thanprospectively collected records and/or We retrospectively reviewed the Received July 14, 2007; final revision received November 5, 2007; accepted November 15, Ad- surgery. images of patients who underwent interventional treatment for benign post- Little is known about the efficacy of dress correspondence to H.Y.S.; hysong@ amc.seoul.kr balloon dilation for early benign anas-operativtomotic strictures ( 3 months after Patients were included in the study if strictures after gastric surgery. None of the authors have identified a conflict of gastric surgery) (5,11). Furthermore, interest. they had documented early 3 ( the treatment of patients with benignmonths) benign anastomotic strictures SIR, 2008 anastomotic or gastric outlet strictures after gastric surgery; obstruction of an DOI: /j.jvir refractory to balloon dilation usually anastomotic site verified on a contrast 565

2 566 Palliation of Strictures after Gastric Surgery April 2008 JVIR medium-enhanced study; the presence of symptoms such as nausea, vomiting, and dysphagia; and no response to conservative treatment (nasogastric tube insertion with acid-suppressive drug). Patients were excluded if they had late ( 3 months) benign anastomotic strictures and anastomotic strictures caused by malignancy or marginal ulcers. From June 1997 to August 2006, 6,137 patients underwent gastric surgeries at three centers, and 63 patients were treated for early benign anastomotic strictures after gastric surgery. A summary of patient characteristics is given in Table 1. Benign strictures at the anastomotic site were diagnosed with endoscopic biopsy. Upper gastrointestinal series and endoscopy were performed within 2 weeks of the procedure to confirm the degree and location of the stricture. The study protocol was approved by our institutional review board, and all patients provided written informed consent at enrollment. Balloon Dilation and Stent Placement The pharynx of each patient was topically anesthetized with an aerosol spray before the procedure. Drugs for conscious sedation were used. The balloon dilation technique was similar to that reported previously (7,9,11). Briefly, a inch angled exchange guide wire (Radifocus M; Terumo, Tokyo, Japan) was inserted under fluoroscopic guidance through the mouth, across the stricture, and into the stomach, duodenum, or jejunum. A mm-diameter noncompliant, low-pressure angioplasty balloon catheter (Medi-Tech/Boston Scientific, Watertown, Mass) was passed over the guide wire to a position over the stricture. The balloon was slowly inflated with hand pressure for 1 minute with diluted water-soluble contrast medium until the hourglass deformity created by the stricture disappeared from the balloon contour or the patient could not tolerate further inflation. The inflation was repeated one to two times at 1-minute intervals. A pressure gauge was not used. Stent placement was indicated in patients who showed no response to balloon dilation (n 5) or frequent symptom recurrence within 2 weeks (n 2). Fully covered retrievable stents (Taewoong, Ilsan, Korea) were Table 1 Summary of Patient Characteristics Parameter Value No. of patients 63 Mean age standard deviation (y)* (29 76) M/F ratio 41/22 Indication for surgery Tumor 57 Benign 6 Anastomotic site 18 Esophagogastrostomy Gastrojejunostomy 18 Esophagojejunostomy 20 Gastroduodenostomy 7 Mean time between surgery and symptom recurrence (d)* (5 90) * Numbers in parentheses are ranges. used for temporary purposes (up to 2 months) (16). Because of their low migration rates and high ability to conform to tortuous strictures, partially covered dual stents (S&G Biotech, Seongnam, Korea) were used in patients with high migration risks due to severely angulated strictures (17). Four patients received temporary stents (16 mm in diameter and 8 and 10 cm in length) and three received permanent stents (18 mm in diameter and 6, 8 cm in length). Stent placement techniques and measurements of stricture length have been described previously (16,17). In brief, a stiff angled, 260-cm-long, inch exchange guide wire (Radifocus M) was inserted under fluoroscopic guidance through the mouth across the obstruction and into the stomach. The stent delivery system was advanced over the guide wire, placing the former in the anastomotic site passing through the obstruction, and the stent was released. The removal of the fully covered retrievable stent was performed after temporary stent placement or in cases of stentrelated complications such as stent migration. The stents were removed under fluoroscopic guidance by using a retrieval hook (16). When the hook grasped and pulled the drawstring of the proximal end of the stent into a sheath, the proximal end collapsed and the stent could be removed. Follow-up To verify passage disturbance, all patients underwent an upper gastrointestinal series with barium 1 month after the procedure, with additional follow-up upper gastrointestinal series performed in patients with recurrent symptoms. All patients were contacted by telephone every 3 months to obtain information about food intake and dysphagia. Analysis of Data Clinical success was scored as relief of obstructive symptoms after the procedure, without additional treatment until the last follow-up or death. Complications and related interventions were evaluated. The patients were divided into two groups good responders and poor responders according to their response to balloon dilation. A good responder was defined as a patient who required only one balloon dilation to relieve obstructive symptoms, whereas a poor responder was defined as a patient who required more than one balloon dilation or stent placement, percutaneous gastrojejunostomy, or surgical revision to relieve obstructive symptoms. Statistical Analysis Continuous variables in good and poor responders were compared by using the Student t test, and categorical variables were compared with the X 2 or Fisher exact test. Variables with a P value of less than.1 at univariate analysis were entered into a multivariate logistic regression model; this lenient P value was chosen to avoid rejection of a variable that could po-

3 Volume 19 Number 4 Kim et al 567 tentially contribute to predicting outcome in multivariable analysis. A multivariate logistic regression model with forward stepwise selection was used to identify independent predictive factors while controlling for confounding factors. A two-sided P value of less than.05 was considered statistically significant. All statistical analyses were performed by using a software package (version 11.5; SPSS, Chicago, Ill). RESULTS Balloon Dilation A total of 107 balloon dilation sessions (mean, 1.7 sessions; range, 1 9 sessions) were successfully performed in 63 patients (Fig 1). In three of the 107 sessions (3%), a small intramural rupture (seen as intramural leakage of contrast media and natural drainage of leaked contrast media back into the esophageal lumen at esophagography) occurred after balloon dilation, all of which disappeared within 3 days after conservative treatments such as fasting, antibiotics (a combination of cephalosporins and amikacin), and parenteral alimentation. Ten patients showed no response to balloon dilation (Table 2). In eight patients, strictures caused by edema during balloon dilation showed mild waist formation with recoil phenomenon. In the other two patients, both of whom had fibrotic strictures, balloon dilation had no effect because the strictures were severely angulated. After stent placement, five of these 10 patients showed symptom improvement. The remaining five patients underwent surgical revision (n 3) or percutaneous gastrojejunostomy (n 2). Of the 63 patients, 31 (49%) showed a good response to the initial balloon dilation and required no further treatment until the end of follow-up or death. Conversely, 32 patients (51%) had a poor response, no response, or recurrence after initial balloon dilation and required multiple balloon dilations (n 20), stent placement (n 7), percutaneous gastrojejunostomy (n 2), or surgical revision (n 3). At univariate analysis, sex (P.027), anastomotic site (P.001), and balloon diameter (P.023) differed significantly between the groups of good and poor responders, whereas Figure 1. Images in a 57-year-old woman with an early anastomotic stricture after total gastrectomy and esophagojejunostomy for gastric cancer. (a) Fluoroscopic image obtained 3 days before balloon dilation after the oral intake of barium shows a severe stricture (arrows) at the anastomotic site. (b, c) Fluoroscopic images show dilation of the stricture with a 20-mm-diameter balloon until disappearance of the waist formation. (d) Fluoroscopic image obtained 1 month after balloon dilation and after the oral intake of barium shows marked improvement of the stricture. age, indication for surgery, and time between surgery and balloon dilation did not (Table 3). When the three significant variables (sex, anastomotic site, and balloon diameter) were entered into a multiple logistic regression model, we found that anastomotic site was the only independent factor predictive of the response to balloon therapy (odds ratio, 9.02; 95% confidence interval: 2.67, 30.40; P.001).

4 568 Palliation of Strictures after Gastric Surgery April 2008 JVIR Table 2 Characteristics of Patients Showing No Response to Balloon Dilation Patient No./Age (y)/sex Site of Strictures Cause of Strictures Related Treatment 1/61/M Gastrojejunostomy Edema Percutaneous gastrojejunostomy 2/29/F Gastroduodenostomy Edema Surgical revision 3/52/F Gastroduodenostomy Edema Surgical revision 4/65/M Gastrojejunostomy Edema Percutaneous gastrojejunostomy 5/73/M Gastrojejunostomy Edema Surgical revision 6/68/M Gastrojejunostomy Edema Stent placement 7/68/F Gastrojejunostomy Edema Stent placement 8/72/M Gastrojejunostomy Edema Stent placement 9/52/M Gastrojejunostomy Fibrotic Stent placement 10/70/M Esophagojejunostomy Fibrotic Stent placement Table 3 Comparison between Groups of Good and Poor Responders Parameter Good Responders (n 31) Poor Responders (n 32) P Value Mean age (y) NS M/F ratio 16/15 25/7.027 Indication for surgery Tumor NS Benign 3 3 NS Site Esophagogastrostomy or gastrojejunostomy Esophagojejunostomy or gastroduodenostomy Mean time between surgery and initial balloon dilation (d) NS Mean balloon diameter (mm) Note. NS not significant. Stent Placement In the seven patients who underwent stent placement, the mean number of attempted balloon dilations before stent placement was 1.6 (range, 1 3). All seven patients showed symptom improvement immediately after stent placement. Stent migration occurred in three of the four patients who received temporary stents 1, 5, and 40 days after stent placement. After removal of the migrated stents, two of these three patients underwent surgical revision to relieve the obstructive symptoms; the remaining patient, however, who had had a stent placed for 40 days, did not require further therapy until the end of follow-up (17 months) because of improved obstructive symptoms (Fig 2). The stent was removed from the fourth patient, who received a temporary stent 2 months after placement; this patient had shown symptom improvement up to the time of this article (80 months). All three patients who received permanent stents showed improvement of symptoms with no complications until the end of follow-up (3 6 months). Finally, clinical success was achieved in five of the seven patients who underwent stent placement for refractory strictures to balloon dilations. Follow-up During a mean follow-up period of 12 months (range, 1 86 months), overall clinical success was achieved in 56 patients (89%) after a single balloon dilation (n 31), multiple balloon dilations (n 20), and stent placement (n 5). The remaining seven patients with clinical failure (11%) after balloon dilation or stent placement underwent surgical revision (n 5) or percutaneous gastrojejunostomy (n 2). DISCUSSION During the past 2 decades, endoscopically or fluoroscopically guided balloon dilation has been regarded as a safe and effective treatment for patients with benign strictures of the upper gastrointestinal tract (1 15,18 20). Among the lesions ideally suited to balloon therapy are benign anastomotic strictures, which are usually short lesions resulting from single, discrete events (19,20). Indeed, the clinical efficacy of balloon therapy has been higher in patients with benign anastomotic strictures (93% 100%) than in those with peptic (67% 76%) or corrosive (21% 35%) strictures (8,10, 12,13,15,21,22). The efficacy of balloon dilation for early postoperative strictures, however, is not clear. (5,11). In a study of gastric outlet obstruction in 40 patients who had undergone vertical banded gastroplasty or gastric bypass surgery for morbid obesity, endoscopic balloon dilation was effective in 13 of 16 patients (81%) with early postoperative (.3 months) strictures, but in only 14 of 24 patients (58%) with late ( 3

5 Volume 19 Number 4 Kim et al 569 Figure 2. Images in a 72-year-old woman with an early anastomotic stricture after subtotal gastrectomy and gastrojejunostomy for gastric cancer. (a) Fluoroscopic image obtained 4 days before stent placement and after the oral intake of nonionic contrast medium shows a severe stricture (arrows) at the efferent loop, blocking the passage of contrast media through the stricture. (b) Endoscopic image shows the stricture (arrowhead) caused by edema. (c) Fluoroscopic image obtained immediately after stent placement (arrowheads) and after the oral intake of nonionic contrast medium shows good passage of the contrast medium. (d) Fluoroscopic image obtained 40 days after the placement of a temporary stent shows marked improvement of the stricture. (Available in color online at months) postoperative strictures (5). In another study, however, patients with late (mean, 18 months) postoperative strictures responded better to balloon dilation than did those with early (mean, 5 months) postoperative strictures (11). This discrepancy may have been due to differences in patient demographics. For example, angulated strictures refractory to balloon therapy were present in 33% of patients with late postoperative strictures but in none of the patients with early postoperative strictures (5). We observed overall clinical success in 56 of the 63 patients (89%) with early postoperative strictures after a single balloon dilation (n 31), multiple balloon dilations (n 20), and stent placement (n 5) after a mean follow-up of 12 months (range, 1 86 months). Because 81% of patients benefited from balloon dilation alone with minor complications, this procedure should be performed as the first-lined therapy for patients with early anastomotic strictures after gastric surgery. As in earlier reports, however, two patients with severely angulated fibrotic strictures were resistant to balloon therapy (5,12). In addition, we found that eight patients with edematous strictures showed mild waist formation with recoil phenomenon during balloon dilations, without any improvement in the strictures. We found that the time from gastric surgery to commencement of balloon dilation had no effect on outcome. A 3-week interval has been suggested as the minimum safe time between surgery and dilation of an anastomotic stricture (23). We performed dilations as early as 2 weeks after surgery, without notable complications. Conversely, the anastomotic site was a strong predictor of outcome: Patients with esophagogastrostomy or gastrojejunostomy sites showed a significantly poorer response to balloon dilation than did patients with esophagojejunostomy or gastroduodenostomy sites. The former sites may be more likely to have angulated or tortuous strictures than the latter. Early surgical revision has been recommended for patients with benign anastomotic or gastric outlet strictures refractory to initial balloon dilation because these patients are unlikely to respond better to subsequent balloon dilations (8,11). Thus, finding another effective treatment modality remains an important therapeutic challenge. We performed stent placement in seven patients who had no response or symptomatic recurrence within 2 weeks after balloon dilation, with five

6 570 Palliation of Strictures after Gastric Surgery April 2008 JVIR of these patients (71%) benefiting from temporary (n 2) or permanent (n 3) stent placement. Because a stent has a persistent dilation effect after placement, it is an attractive therapeutic modality in patients with obstinate early postoperative strictures after gastric surgery. The major drawback of stent placement in a benign anastomotic stricture may be stent migration. In general, benign anastomotic strictures are short in length and somewhat straight in course, increasing the likelihood of stent migration (24). Furthermore, a fully covered stent is insufficiently anchored to the intestinal wall (25), thus increasing the possibility of stent migration. We found that three of the four fully covered retrievable stents migrated before scheduled elective stent removal. Future fully covered stents should be designed to prevent migration (26) and to be retrievable for temporary placement. The conformability of the stent to the tortuosity of the gastrointestinal area and incorporation of the parts of the stent into the gastrointestinal wall may prevent the stent from migrating (17). In areas of high migration risks due to severely angulated strictures, dual stents are more suitable given their low migration rates and high ability to confirm to tortuous strictures (27). Our findings indicate that patients with early anastomotic strictures after gastric surgery should be treated initially by means of balloon dilation. Patients who show no response or those who have frequent recurrences after balloon dilation should receive temporary, fully covered retrievable stents. Patients at high risk of stent migration due to severely angulated strictures should receive partially covered dual stents or undergo surgery. References 1. Kretzschmar CS, Hamilton JW, Wissler DW, Yale CE, Morrissey JF. 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