- Email: [email protected]
Peroral endoscopic anastomotic reduction improves intractable dumping syndrome in Roux-en-Y gastric bypass patients
Surgery for Obesity and Related Diseases 6 (2010) 36 – 40
Original article
Peroral endoscopic anastomotic reduction improves intractable dumping syndrome in Roux-en-Y gastric bypass patients Gloria Fernández-Esparrach, M.D., Ph.D.a, David B. Lautz, M.D.b, Christopher C. Thompson, M.D., M.Sc., F.A.C.G., F.A.S.G.E.a,* a Department of Medicine, Division of Gastroenterology, Brigham and Women’s Hospital, Boston, Massachusetts Department of Surgery, Division of General and Gastrointestinal Surgery, Brigham and Women’s Hospital, Boston, Massachusetts Received September 27, 2008; revised April 6, 2009; accepted April 8, 2009
b
Abstract
Background: Dumping syndrome is a well-described consequence of Roux-en-Y gastric bypass. Although the condition can benefit some patients with morbid obesity, a subset will develop intractable dumping syndrome characterized by symptomatic episodes with most meals. We describe the first series of patients successfully treated endoscopically for intractable dumping syndrome. Methods: Endoscopic gastrojejunal anastomotic reduction was performed in patients with intractable dumping syndrome after Roux-en-Y gastric bypass using a combination of argon plasma coagulation, endoscopic suturing, and fibrin glue. The technical feasibility of endoscopic anastomotic reduction and the clinical improvement in dumping symptoms were assessed by clinical follow-up. Results: Endoscopic anastomotic reduction was technically successful in 6 consecutive patients with a dilated gastrojejunal anastomosis and intractable dumping syndrome. One patient reported hematemesis 2 days after the procedure that was treated endoscopically. No other significant complications occurred. Complete and persistent resolution of the dumping symptoms was achieved in all patients, with a median follow-up of 636 days. Conclusion: Endoscopic anastomotic reduction appears technically feasible and safe and might be a minimally invasive treatment option for patients who experience intractable dumping symptoms after Roux-en-Y gastric bypass. Additional studies are needed to determine the long-term efficacy of this procedure. (Surg Obes Relat Dis 2010;6:36 – 40.) © 2010 American Society for Metabolic and Bariatric Surgery. All rights reserved.
Keywords:
Dumping syndrome; Endoscopic anastomotic reduction; Gastric bypass; Morbid obesity
Roux-en-Y gastric bypass (RYGB) is the most common bariatric surgical procedure performed in the United States, with ⬎80,000 procedures performed in 2003 [1]. Dumping syndrome is an extremely common consequence of the G. Fernández-Esparrach is currently at Hospital Clínic, University of Barcelona, Institut d’Investigacions Biomèdiques August Pi i Sunyer (IDIPAPS), Centro de Investigación Biomédica en Red en el Área temática de Enfermedades Hepáticas y Digestivas (CIBEREHD), Barcelona, Spain. *Reprint requests: Christopher C. Thompson, MD, MSc, FACG, FASGE, Division of Developmental Endoscopy, Brigham and Women’s Hospital, 75 Francis Street, Boston, MA 02115. E-mail: [email protected]
procedure, and its reported incidence has varied widely (15–50%) [2]. In patients who have dumping syndrome, high-osmolarity foods pass rapidly through the small-volume gastric pouch and cause an osmotic overload on entering the small intestine. This osmotic overload brings fluid into the lumen of the small intestine, resulting in a vagal reaction. Patients with dumping syndrome will often complain of diarrhea, lightheadedness, sweating, and fatigue after eating a high-glucose meal or drinking fluid with a meal. Despite frequent diarrhea, nutritional problems are rare because sufficient distal bowel is usually present for nutrient absorption [3], and the episodes are typically self-
1550-7289/10/$ – see front matter © 2010 American Society for Metabolic and Bariatric Surgery. All rights reserved. doi:10.1016/j.soard.2009.04.002
G. Fernández-Esparrach et al. / Surgery for Obesity and Related Diseases 6 (2010) 36 – 40
37
symptoms were recorded. Patients then underwent routine screening endoscopy. At endoscopy, the gastric pouch and the area of the gastrojejunostomy were evaluated for signs of post-RYGB complications. In addition, the size of the gastrojejunostomy and the length of the gastric pouch were recorded. Those patients with symptoms of intractable dumping syndrome and gastrojejunostomies ⬎18 mm in diameter were offered endoscopic anastomotic reduction. All the patients provided written informed consent. We included consecutive patients, and the institutional review board approved the study protocol. Endoscopic anastomotic reduction
Fig. 1. Gastrojejunal anastomosis measurement before procedure. Each mark represents 2 mm of length.
limited. Most often, the dumping syndrome is temporary and can be avoided with dietary manipulation. However, a small subset of patients develop intractable dumping syndrome characterized by symptomatic episodes with most meals that can significantly affect their quality of life. In these cases, subcutaneous injections of the somatostatin analogue octreotide will effectively reduce the symptoms [4]. Accelerated gastric emptying of liquids is a characteristic feature and a critical step in the pathogenesis of the dumping syndrome [5]. In the normal stomach, gastric emptying is modulated by a complex system involving fundic tone, antropyloric mechanisms, and duodenal feedback. RYGB substantially impairs or eliminates these mechanisms. The fundic reservoir is eliminated, thereby reducing the stomach’s receptiveness to a meal. In addition, duodenal feedback inhibition of gastric emptying is lost after gastrojejunostomy. Although intractable dumping syndrome after RYGB represents a relatively rare problem, the patients who develop it suffer significantly, with few clinical treatment options. We theorized that endoscopic tightening of the gastrojejunostomy in patients with intractable dumping syndrome would lead to delayed emptying of the gastric pouch and result in symptomatic improvement. This series highlights our experience using this novel endoscopic tightening procedure to treat intractable dumping syndrome after RYGB.
All anastomotic reductions were performed in the endoscopy unit by a single endoscopist with the patient under general endotracheal anesthesia administered by a staff anesthesiologist. Measurement of the gastrojejunostomy aperture was performed using an endoscopic ruler (Fig. 1). The pouch size was estimated by measuring pouch length using endoscope markings. Endoscopic reduction was conducted using a modification of a previously described technique [6,7]. Endoscopic suturing was preceded by gastrojejunal anastomosis mucosal ablation using argon plasma coagulation (Fig. 2). Endoscopic sutures were then placed at the rim of the anastomosis using the EndoCinch suturing system (CR Bard, Murray Hill, NJ; Fig. 3A). The device was removed and reloaded as necessary. Each interrupted stitch was created by placed suture at the anterior and posterior margins of the anastomosis. The stitches were placed starting on the left end of the anastomosis and moving to the right for subsequent stitches. After all the stitches were placed, the sutures were tightened and secured to form tissue plications, reducing the size of the anastomosis, with the goal a final diameter of ⬍1 cm (Fig. 3B). Fibrin glue
Methods Inclusion criteria The patients who were referred to our center for evaluation and/or treatment of symptoms thought to be related to intractable dumping syndrome after RYGB were evaluated for possible endoscopic management. All dumping-related
Fig. 2. Aspect of gastrojejunal anastomosis denuded with argon plasma coagulation before suturing.
38
G. Fernández-Esparrach et al. / Surgery for Obesity and Related Diseases 6 (2010) 36 – 40
Statistical analysis Statistical analysis was performed using the Statistical Package for Social Sciences software (SPSS, Chicago, IL). Continuous variables are expressed as the mean ⫾ SD. Continuous variables were compared using the paired Wilcoxon test. Results
Fig. 3. Endoscopic suturing. (A) Placement of sutures. (B) Sutures tightened and secured to form tissue placations.
From July 2005 to July 2007, a total of 20 patients with RYGB presented with dumping symptoms. However, only 6 (30%) had intractable dumping syndrome and presented with a dilated gastrojejunal anastomosis. All patients were women, with a mean age of 45 ⫾ 11 years (range 33– 63) and an average preprocedure body mass index (BMI) of 34.5 ⫾ 7.1 (Table 1). The intractable dumping symptoms reported before the endoscopic procedure are listed in Table 1 and included immediate postprandial nausea and severe diarrhea in all patients. Diaphoresis, hypoglycemia, shaking, and palpitations were also reported by some patients. Five patients reported symptoms severe enough to significantly limit their daily activity. The technical characteristics of the procedure are detailed in Table 2. Before the procedure, the mean pouch length and mean anastomotic diameter was 5 ⫾ 1 cm and 23 ⫾ 4.5 mm, respectively. At least 2 interrupted stitches were placed in the rim of the anastomosis in all cases. After reduction, the average gastrojejunal anastomosis diameter was 8 ⫾ 0.4 mm (P ⫽ .027). All procedures were performed without immediate complications. However, 1 patient reported hematemesis 2 days after the procedure and was found to have a nonbleeding ulcer with clotting. She was treated with placement of a hemostatic clip. No other complications were reported. In all 6 cases, the intractable dumping symptoms resolved completely and immediately after the procedure. All
was then applied to the sutured areas (Fig. 4). The final anastomotic apertures were measured using the endoscopic ruler, and the pouch was carefully inspected for complications. All patients were discharged home the same day with instructions regarding diet, volume intake, proton pump inhibitor therapy, symptoms, and follow-up visits. Patients were instructed to consume a full liquid diet for 2 weeks, followed by soft solids for 1 month. Outcomes All patients were followed up in the outpatient clinic and were weighed on the same digital scale. They were asked about postprocedure symptoms, diet, eating habits, activity, and satiety levels. Changes in their previous dumping-related symptoms were measured using a 0 – 4 visual analog scale. Outcome questions were asked by telephone interview for 2 patients who were not able to return for a particular clinic visit.
Fig. 4. Gastrojejunal anastomosis after reduction.
G. Fernández-Esparrach et al. / Surgery for Obesity and Related Diseases 6 (2010) 36 – 40
39
Table 1 Patient characteristics Pt. No.
Age (y)
Gender
Original surgery (type/date)
Endoscopy date
BMI (kg/m2)
GJ anastomosis (mm)
Symptoms
1
37
Female
—/March 2000
June 2006
32.7
18
2 3 4 5 6
42 55 41 33 63
Female Female Female Female Female
Laparoscopic/Feb 2005 Laparoscopic/May 2004 Laparoscopic/May 2003 Open/June 2002 Open/Sep 2003
Oct 2006 July 2005 Aug 2005 April 2006 Jan 2006
31.3 30.5 26.3 41.5 44.9
20 25 20 25 30
Severe diarrhea, diaphoresis Severe diarrhea, Severe diarrhea, Severe diarrhea, Severe diarrhea, Severe diarrhea,
nausea, hypoglycemia, nausea, shaking, palpitations nausea nausea nausea nausea
Pt. No. ⫽ patient number; BMI ⫽ body mass index; GJ ⫽ gastrojejunal.
patients remained free of symptoms at a median follow-up of 636 days. Of the 6 patients, 5 reported initial weight loss after the procedure, although the final mean BMI at the last follow-up visit was not significantly different from the BMI before the procedure (33 ⫾ 6 versus 34.5 ⫾ 7.1; P ⫽ .35). Discussion RYGB remains the most common bariatric surgical procedure in the United States, and its effectiveness in inducing significant weight loss has been well-documented [8 –10]. Although dumping syndrome is a common effect after gastric bypass that might help patients adjust their dietary habits and attain their weight loss goals, intractable dumping syndrome that significantly affect their quality of life is relatively rare. A general agreement has been reached that accelerated gastric emptying of liquids is a characteristic feature and a critical step in the pathogenesis of the dumping syndrome [5,11]. In the case of RYGB for morbidly obese patients, the restrictive purpose of the surgery leads to the construction of a small pouch and somewhat intentional dumping symptoms. However, when these symptoms are severe and no improvement occurs with dietary adjustments, surgical reduction of the gastrojejunal anastomosis has been shown to induce a delay in pouch emptying and resolution of the symptoms [12]. The technical feasibility of an endoscopic suturing method for the reduction of the gastrojejunal anastomotic Table 2 Technical characteristics Pt. No.
Pouch (cm)
GJ anastomosis before procedure (mm)
Interrupted stitches (n)
Fibrin glue (cm3)
GJ anastomosis after procedure (mm)
1 2 3 4 5 6 Mean
4 — 3 6 5 5 5⫾1
18 20 25 20 25 30 23 ⫾ 4.5*
3 3 3 3 2 3 3 ⫾ 0.4
2 5 3 10 2 3 4⫾3
8 8 8 7 8 8 8 ⫾ 0.4*
Abbreviations as in Table 1. * P ⬍.05.
aperture was first described by Thompson and Carl-Locke [13] in patients with significant weight regain after RYGB. This procedure was performed in an attempt to enhance the restrictive properties of the dilated gastric pouch and restore postprandial satiety. The technical feasibility was confirmed by publication of a 4-patient series using a similar technique by Schweitzer [14]. No weight data were reported in that early study. Subsequently, a pilot study using the Bard EndoCinch was reported [7]. In that pilot study, the investigators achieved an average reduction in diameter of 68%, without significant complications. After the first reduction, 6 of 8 patients had weight loss (mean 10 kg) at 4 months. At the end of the follow-up period, the average postreduction BMI was 37.7 kg/m2, and the percentage of excess weight loss was 23.4%. The EndoCinch suturing system was initially developed for the endoscopic treatment of gastroesophageal reflux disease [15,16]. The device allows the placement of sutures in the gastric cardia that are intended to produce tightening of the gastroesophageal junction and resolution of gastroesophageal reflux disease. The EndoCinch system has also been used in postgastric bypass patients to place sutures around staple line defects to close gastrogastric fistulas [6,17]. Although gastric pouch emptying before and after the procedure was not measured, the improvement of symptoms can be explained by the delay in gastric pouch emptying secondary to effective endoscopic anastomotic reduction, as described in surgical series [12]. However, the patients were advised to consume a liquid diet for 2 weeks and a soft diet for an additional 4 weeks after the procedure, and these changes in the dietary pattern could have contributed to the initial weight loss. In the present pilot work, endoscopy was not performed after the procedure; thus, we could not correlate the improvement in symptoms with persistent changes in the anatomy. However, that the patients were free of symptoms at a median follow-up of 636 days has demonstrated the treatment’s durability. An additional weakness of the present study was that we did not have a group control and thus could not exclude a possible placebo effect. Also, although all the patients were instructed to follow a heart-healthy, low-fat diet, we did not have the exact dietary changes the patients actually followed after the procedure.
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G. Fernández-Esparrach et al. / Surgery for Obesity and Related Diseases 6 (2010) 36 – 40
Immediate transient abdominal discomfort was experienced by all patients; however, only 1 major complication developed. Hemorrhage occurred in 1 patient 2 days after the procedure, and endoscopy showed a nonbleeding ulcer with a clot. This was successfully treated endoscopically by clot removal and placement of 1 endoclip, without further incidence. The technique used in the present report was modified from that initially described [6,7]. First, in all cases, the mucosa at the rim of the anastomosis was ablated using argon plasma coagulation with the intention of allowing fusion of the apposed tissue and inducing a more severe inflammatory and fibrotic response. Additionally, a tissue sealant was used as a barrier to protect the sutured area in the immediate postprocedure period in an attempt to facilitate tissue healing. Recently, other endoscopic suturing devices that have the potential to reduce the anastomosis and pouch have been developed and marketed. The transoral endoscopic anchor placement system (EndoSurgical Operating System, USGI Medical, San Clemente, CA), which demonstrated a 53% stoma diameter reduction in an in vivo animal study [18], has already been used in humans [18,19]. In that preliminary study of 20 patients, tissue plications could be placed in 17 (85%) of the 20 patients, with a mean of 5 (range 0 –11) plications placed. The gastrojejunal anastomotic diameter and gastric pouch length was reduced by an average of 16 mm and 2.5 cm, respectively, without significant complications. After the reduction, the average weight loss was 5.8 kg at 1 month. In contrast, the patients in whom placations could not be placed gained an average of 5 kg within the same period [19]. Additionally, the StomaphyX (EndoGastric Solutions, Redmond, WA) is a transoral device that creates tissue plications and has been successfully used for the management of gastric leaks in 2 patients after RYGB [20]. However, the published experience with these 2 devices is scarce, and more studies are needed.
Conclusion According to this initial series, the gastrojejunal aperture appears to have an effect on the symptoms of patients with intractable dumping syndrome. Additionally, endoscopic anastomotic reduction appears to be safe and could offer a minimally invasive treatment option for patients who experience intractable dumping symptoms after RYGB. Additional prospective studies with larger numbers of patients and more substantial follow-up are needed to confirm these early findings.
Disclosures G. Fernández-Esparrach was supported by a grant from Generalitat de Catalunya (AGAUR, BE-100022). The au-
thors claim no commercial associations that might be a conflict of interest in relation to this article. References [1] Santry HP, Gillen DL, Lauderdale DS. Trends in bariatric surgical procedures. JAMA 2005;294:1909 –17. [2] Buhl K, Schlag P, Herfath C. Quality of life and functional results following different types of resection for gastric carcinoma. Eur J Surg Oncol 1990;16:404 –9. [3] Fujioka K. Follow-up of nutritional and metabolic problems after bariatric surgery. Diabetes Care 2005;28:481– 4. [4] Hopman WP, Wolberink RG, Lamers CB, Van Tongeren JH. Treatment of the dumping syndrome with the somatostatin analogue SMS 201-995. Ann Surg 1988;207:155–9. [5] Hobsley M. Dumping and diarrhea. Br J Surg 1981;68:681– 4. [6] Thompson C, Carr-Locke D, Saltzman J, Lautz D, Robinson M. Peroral endoscopic repair of staple-line dehiscences in Roux-en-Y gastric bypass: a less invasive approach (abstract). Gastrointest Endosc 2004;126(Suppl 2):A810. [7] Thompson CC, Slattery J, Bundga ME, Lautz DB. Peroral endoscopic reduction of dilated gastrojejunal anastomosis after Roux-en-Y gastric bypass: a possible new option for patients with weight regain. Surg Endosc 2006;20:1744 – 8. [8] Brolin RE. Update: NIH consensus conference. Gastrointestinal surgery for severe obesity. Nutrition 1996;12:403– 4. [9] Schauer PR, Ikramuddin S, Gourash W, et al. Outcomes after laparoscopic gastric Roux-en-Y gastric bypass for morbid obesity. Ann Surg 2000;232:515–29. [10] Mun EC, Blackburn GL, Matthews JB. Current status of medical and surgical therapy for obesity. Gastroenterology 2001;120:669 – 81. [11] Ralphs DNL, Thompson JPS, Haynes S, Lawson-Smith C, Hobsley M, Le Quesne LP. The relationship between the rate of gastric emptying and the dumping syndrome. Br J Surg 1978;65:637– 41. [12] Carvajal SH, Mulvihill SJ. Postgastrectomy syndromes: dumping and diarrhea. Gastroenterol Clin North Am 1994;23:261–79. [13] Thompson C, Carr-Locke D. Novel endoscopic approaches to common bariatric postoperative complications. Presented at: Digestive Disease Week, ASGE Video Forum; May 15–20, 2004; New Orleans, La. [14] Schweitzer M. Endoscopic intraluminal suture plication of the gastric pouch and stoma in postoperative Roux-en-Y gastric bypass patients. J Laparoendosc Adv Surg Tech A 2004;14:223– 6. [15] Filipi CJ, Lehman GA, Rothstein RI, et al. Transoral, flexible endoscopic suturing for treatment of GERD: a multicenter trial. Gastrointest Endosc 2001;53:416 –22. [16] Mahmood Z, McMahon BP, Arfin Q, et al. EndoCinch therapy for gastroesophageal reflux disease: a one-year prospective follow-up. Gut 2003;52:34 –9. [17] Pai RD, Doktor V, Lautz DB, Thompson CC. Peroral endoscopic repair of fistulae in Roux-en-Y gastric bypass patients: a clinical experience in 25 patients. Gastroenterology 2007;132:A79. [18] Herron DM, Birkett DH, Thompson CC, Bessler M, Swanstrom LL. Gastric bypass pouch and stoma reduction using a transoral endoscopic anchor placement system: a feasibility study. Surg Endosc 2008;22:1093–9. [19] Mullady DK, Lautz DB, Thompson CC. Treatment of weight regain following gastric bypass surgery using a novel endoscopic device: technical feasibility and early outcomes in twenty patients. Presented at: Digestive Disease Week, ASGE Video Forum; May 17–22, 2008; San Diego, Ca. [20] Overcash WT. Natural orifice surgery (NOS) using StomaphyX™ for repair of gastric leaks after bariatric revisions. Obes Surg 2008;18:882–5.
Original article
Peroral endoscopic anastomotic reduction improves intractable dumping syndrome in Roux-en-Y gastric bypass patients Gloria Fernández-Esparrach, M.D., Ph.D.a, David B. Lautz, M.D.b, Christopher C. Thompson, M.D., M.Sc., F.A.C.G., F.A.S.G.E.a,* a Department of Medicine, Division of Gastroenterology, Brigham and Women’s Hospital, Boston, Massachusetts Department of Surgery, Division of General and Gastrointestinal Surgery, Brigham and Women’s Hospital, Boston, Massachusetts Received September 27, 2008; revised April 6, 2009; accepted April 8, 2009
b
Abstract
Background: Dumping syndrome is a well-described consequence of Roux-en-Y gastric bypass. Although the condition can benefit some patients with morbid obesity, a subset will develop intractable dumping syndrome characterized by symptomatic episodes with most meals. We describe the first series of patients successfully treated endoscopically for intractable dumping syndrome. Methods: Endoscopic gastrojejunal anastomotic reduction was performed in patients with intractable dumping syndrome after Roux-en-Y gastric bypass using a combination of argon plasma coagulation, endoscopic suturing, and fibrin glue. The technical feasibility of endoscopic anastomotic reduction and the clinical improvement in dumping symptoms were assessed by clinical follow-up. Results: Endoscopic anastomotic reduction was technically successful in 6 consecutive patients with a dilated gastrojejunal anastomosis and intractable dumping syndrome. One patient reported hematemesis 2 days after the procedure that was treated endoscopically. No other significant complications occurred. Complete and persistent resolution of the dumping symptoms was achieved in all patients, with a median follow-up of 636 days. Conclusion: Endoscopic anastomotic reduction appears technically feasible and safe and might be a minimally invasive treatment option for patients who experience intractable dumping symptoms after Roux-en-Y gastric bypass. Additional studies are needed to determine the long-term efficacy of this procedure. (Surg Obes Relat Dis 2010;6:36 – 40.) © 2010 American Society for Metabolic and Bariatric Surgery. All rights reserved.
Keywords:
Dumping syndrome; Endoscopic anastomotic reduction; Gastric bypass; Morbid obesity
Roux-en-Y gastric bypass (RYGB) is the most common bariatric surgical procedure performed in the United States, with ⬎80,000 procedures performed in 2003 [1]. Dumping syndrome is an extremely common consequence of the G. Fernández-Esparrach is currently at Hospital Clínic, University of Barcelona, Institut d’Investigacions Biomèdiques August Pi i Sunyer (IDIPAPS), Centro de Investigación Biomédica en Red en el Área temática de Enfermedades Hepáticas y Digestivas (CIBEREHD), Barcelona, Spain. *Reprint requests: Christopher C. Thompson, MD, MSc, FACG, FASGE, Division of Developmental Endoscopy, Brigham and Women’s Hospital, 75 Francis Street, Boston, MA 02115. E-mail: [email protected]
procedure, and its reported incidence has varied widely (15–50%) [2]. In patients who have dumping syndrome, high-osmolarity foods pass rapidly through the small-volume gastric pouch and cause an osmotic overload on entering the small intestine. This osmotic overload brings fluid into the lumen of the small intestine, resulting in a vagal reaction. Patients with dumping syndrome will often complain of diarrhea, lightheadedness, sweating, and fatigue after eating a high-glucose meal or drinking fluid with a meal. Despite frequent diarrhea, nutritional problems are rare because sufficient distal bowel is usually present for nutrient absorption [3], and the episodes are typically self-
1550-7289/10/$ – see front matter © 2010 American Society for Metabolic and Bariatric Surgery. All rights reserved. doi:10.1016/j.soard.2009.04.002
G. Fernández-Esparrach et al. / Surgery for Obesity and Related Diseases 6 (2010) 36 – 40
37
symptoms were recorded. Patients then underwent routine screening endoscopy. At endoscopy, the gastric pouch and the area of the gastrojejunostomy were evaluated for signs of post-RYGB complications. In addition, the size of the gastrojejunostomy and the length of the gastric pouch were recorded. Those patients with symptoms of intractable dumping syndrome and gastrojejunostomies ⬎18 mm in diameter were offered endoscopic anastomotic reduction. All the patients provided written informed consent. We included consecutive patients, and the institutional review board approved the study protocol. Endoscopic anastomotic reduction
Fig. 1. Gastrojejunal anastomosis measurement before procedure. Each mark represents 2 mm of length.
limited. Most often, the dumping syndrome is temporary and can be avoided with dietary manipulation. However, a small subset of patients develop intractable dumping syndrome characterized by symptomatic episodes with most meals that can significantly affect their quality of life. In these cases, subcutaneous injections of the somatostatin analogue octreotide will effectively reduce the symptoms [4]. Accelerated gastric emptying of liquids is a characteristic feature and a critical step in the pathogenesis of the dumping syndrome [5]. In the normal stomach, gastric emptying is modulated by a complex system involving fundic tone, antropyloric mechanisms, and duodenal feedback. RYGB substantially impairs or eliminates these mechanisms. The fundic reservoir is eliminated, thereby reducing the stomach’s receptiveness to a meal. In addition, duodenal feedback inhibition of gastric emptying is lost after gastrojejunostomy. Although intractable dumping syndrome after RYGB represents a relatively rare problem, the patients who develop it suffer significantly, with few clinical treatment options. We theorized that endoscopic tightening of the gastrojejunostomy in patients with intractable dumping syndrome would lead to delayed emptying of the gastric pouch and result in symptomatic improvement. This series highlights our experience using this novel endoscopic tightening procedure to treat intractable dumping syndrome after RYGB.
All anastomotic reductions were performed in the endoscopy unit by a single endoscopist with the patient under general endotracheal anesthesia administered by a staff anesthesiologist. Measurement of the gastrojejunostomy aperture was performed using an endoscopic ruler (Fig. 1). The pouch size was estimated by measuring pouch length using endoscope markings. Endoscopic reduction was conducted using a modification of a previously described technique [6,7]. Endoscopic suturing was preceded by gastrojejunal anastomosis mucosal ablation using argon plasma coagulation (Fig. 2). Endoscopic sutures were then placed at the rim of the anastomosis using the EndoCinch suturing system (CR Bard, Murray Hill, NJ; Fig. 3A). The device was removed and reloaded as necessary. Each interrupted stitch was created by placed suture at the anterior and posterior margins of the anastomosis. The stitches were placed starting on the left end of the anastomosis and moving to the right for subsequent stitches. After all the stitches were placed, the sutures were tightened and secured to form tissue plications, reducing the size of the anastomosis, with the goal a final diameter of ⬍1 cm (Fig. 3B). Fibrin glue
Methods Inclusion criteria The patients who were referred to our center for evaluation and/or treatment of symptoms thought to be related to intractable dumping syndrome after RYGB were evaluated for possible endoscopic management. All dumping-related
Fig. 2. Aspect of gastrojejunal anastomosis denuded with argon plasma coagulation before suturing.
38
G. Fernández-Esparrach et al. / Surgery for Obesity and Related Diseases 6 (2010) 36 – 40
Statistical analysis Statistical analysis was performed using the Statistical Package for Social Sciences software (SPSS, Chicago, IL). Continuous variables are expressed as the mean ⫾ SD. Continuous variables were compared using the paired Wilcoxon test. Results
Fig. 3. Endoscopic suturing. (A) Placement of sutures. (B) Sutures tightened and secured to form tissue placations.
From July 2005 to July 2007, a total of 20 patients with RYGB presented with dumping symptoms. However, only 6 (30%) had intractable dumping syndrome and presented with a dilated gastrojejunal anastomosis. All patients were women, with a mean age of 45 ⫾ 11 years (range 33– 63) and an average preprocedure body mass index (BMI) of 34.5 ⫾ 7.1 (Table 1). The intractable dumping symptoms reported before the endoscopic procedure are listed in Table 1 and included immediate postprandial nausea and severe diarrhea in all patients. Diaphoresis, hypoglycemia, shaking, and palpitations were also reported by some patients. Five patients reported symptoms severe enough to significantly limit their daily activity. The technical characteristics of the procedure are detailed in Table 2. Before the procedure, the mean pouch length and mean anastomotic diameter was 5 ⫾ 1 cm and 23 ⫾ 4.5 mm, respectively. At least 2 interrupted stitches were placed in the rim of the anastomosis in all cases. After reduction, the average gastrojejunal anastomosis diameter was 8 ⫾ 0.4 mm (P ⫽ .027). All procedures were performed without immediate complications. However, 1 patient reported hematemesis 2 days after the procedure and was found to have a nonbleeding ulcer with clotting. She was treated with placement of a hemostatic clip. No other complications were reported. In all 6 cases, the intractable dumping symptoms resolved completely and immediately after the procedure. All
was then applied to the sutured areas (Fig. 4). The final anastomotic apertures were measured using the endoscopic ruler, and the pouch was carefully inspected for complications. All patients were discharged home the same day with instructions regarding diet, volume intake, proton pump inhibitor therapy, symptoms, and follow-up visits. Patients were instructed to consume a full liquid diet for 2 weeks, followed by soft solids for 1 month. Outcomes All patients were followed up in the outpatient clinic and were weighed on the same digital scale. They were asked about postprocedure symptoms, diet, eating habits, activity, and satiety levels. Changes in their previous dumping-related symptoms were measured using a 0 – 4 visual analog scale. Outcome questions were asked by telephone interview for 2 patients who were not able to return for a particular clinic visit.
Fig. 4. Gastrojejunal anastomosis after reduction.
G. Fernández-Esparrach et al. / Surgery for Obesity and Related Diseases 6 (2010) 36 – 40
39
Table 1 Patient characteristics Pt. No.
Age (y)
Gender
Original surgery (type/date)
Endoscopy date
BMI (kg/m2)
GJ anastomosis (mm)
Symptoms
1
37
Female
—/March 2000
June 2006
32.7
18
2 3 4 5 6
42 55 41 33 63
Female Female Female Female Female
Laparoscopic/Feb 2005 Laparoscopic/May 2004 Laparoscopic/May 2003 Open/June 2002 Open/Sep 2003
Oct 2006 July 2005 Aug 2005 April 2006 Jan 2006
31.3 30.5 26.3 41.5 44.9
20 25 20 25 30
Severe diarrhea, diaphoresis Severe diarrhea, Severe diarrhea, Severe diarrhea, Severe diarrhea, Severe diarrhea,
nausea, hypoglycemia, nausea, shaking, palpitations nausea nausea nausea nausea
Pt. No. ⫽ patient number; BMI ⫽ body mass index; GJ ⫽ gastrojejunal.
patients remained free of symptoms at a median follow-up of 636 days. Of the 6 patients, 5 reported initial weight loss after the procedure, although the final mean BMI at the last follow-up visit was not significantly different from the BMI before the procedure (33 ⫾ 6 versus 34.5 ⫾ 7.1; P ⫽ .35). Discussion RYGB remains the most common bariatric surgical procedure in the United States, and its effectiveness in inducing significant weight loss has been well-documented [8 –10]. Although dumping syndrome is a common effect after gastric bypass that might help patients adjust their dietary habits and attain their weight loss goals, intractable dumping syndrome that significantly affect their quality of life is relatively rare. A general agreement has been reached that accelerated gastric emptying of liquids is a characteristic feature and a critical step in the pathogenesis of the dumping syndrome [5,11]. In the case of RYGB for morbidly obese patients, the restrictive purpose of the surgery leads to the construction of a small pouch and somewhat intentional dumping symptoms. However, when these symptoms are severe and no improvement occurs with dietary adjustments, surgical reduction of the gastrojejunal anastomosis has been shown to induce a delay in pouch emptying and resolution of the symptoms [12]. The technical feasibility of an endoscopic suturing method for the reduction of the gastrojejunal anastomotic Table 2 Technical characteristics Pt. No.
Pouch (cm)
GJ anastomosis before procedure (mm)
Interrupted stitches (n)
Fibrin glue (cm3)
GJ anastomosis after procedure (mm)
1 2 3 4 5 6 Mean
4 — 3 6 5 5 5⫾1
18 20 25 20 25 30 23 ⫾ 4.5*
3 3 3 3 2 3 3 ⫾ 0.4
2 5 3 10 2 3 4⫾3
8 8 8 7 8 8 8 ⫾ 0.4*
Abbreviations as in Table 1. * P ⬍.05.
aperture was first described by Thompson and Carl-Locke [13] in patients with significant weight regain after RYGB. This procedure was performed in an attempt to enhance the restrictive properties of the dilated gastric pouch and restore postprandial satiety. The technical feasibility was confirmed by publication of a 4-patient series using a similar technique by Schweitzer [14]. No weight data were reported in that early study. Subsequently, a pilot study using the Bard EndoCinch was reported [7]. In that pilot study, the investigators achieved an average reduction in diameter of 68%, without significant complications. After the first reduction, 6 of 8 patients had weight loss (mean 10 kg) at 4 months. At the end of the follow-up period, the average postreduction BMI was 37.7 kg/m2, and the percentage of excess weight loss was 23.4%. The EndoCinch suturing system was initially developed for the endoscopic treatment of gastroesophageal reflux disease [15,16]. The device allows the placement of sutures in the gastric cardia that are intended to produce tightening of the gastroesophageal junction and resolution of gastroesophageal reflux disease. The EndoCinch system has also been used in postgastric bypass patients to place sutures around staple line defects to close gastrogastric fistulas [6,17]. Although gastric pouch emptying before and after the procedure was not measured, the improvement of symptoms can be explained by the delay in gastric pouch emptying secondary to effective endoscopic anastomotic reduction, as described in surgical series [12]. However, the patients were advised to consume a liquid diet for 2 weeks and a soft diet for an additional 4 weeks after the procedure, and these changes in the dietary pattern could have contributed to the initial weight loss. In the present pilot work, endoscopy was not performed after the procedure; thus, we could not correlate the improvement in symptoms with persistent changes in the anatomy. However, that the patients were free of symptoms at a median follow-up of 636 days has demonstrated the treatment’s durability. An additional weakness of the present study was that we did not have a group control and thus could not exclude a possible placebo effect. Also, although all the patients were instructed to follow a heart-healthy, low-fat diet, we did not have the exact dietary changes the patients actually followed after the procedure.
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Immediate transient abdominal discomfort was experienced by all patients; however, only 1 major complication developed. Hemorrhage occurred in 1 patient 2 days after the procedure, and endoscopy showed a nonbleeding ulcer with a clot. This was successfully treated endoscopically by clot removal and placement of 1 endoclip, without further incidence. The technique used in the present report was modified from that initially described [6,7]. First, in all cases, the mucosa at the rim of the anastomosis was ablated using argon plasma coagulation with the intention of allowing fusion of the apposed tissue and inducing a more severe inflammatory and fibrotic response. Additionally, a tissue sealant was used as a barrier to protect the sutured area in the immediate postprocedure period in an attempt to facilitate tissue healing. Recently, other endoscopic suturing devices that have the potential to reduce the anastomosis and pouch have been developed and marketed. The transoral endoscopic anchor placement system (EndoSurgical Operating System, USGI Medical, San Clemente, CA), which demonstrated a 53% stoma diameter reduction in an in vivo animal study [18], has already been used in humans [18,19]. In that preliminary study of 20 patients, tissue plications could be placed in 17 (85%) of the 20 patients, with a mean of 5 (range 0 –11) plications placed. The gastrojejunal anastomotic diameter and gastric pouch length was reduced by an average of 16 mm and 2.5 cm, respectively, without significant complications. After the reduction, the average weight loss was 5.8 kg at 1 month. In contrast, the patients in whom placations could not be placed gained an average of 5 kg within the same period [19]. Additionally, the StomaphyX (EndoGastric Solutions, Redmond, WA) is a transoral device that creates tissue plications and has been successfully used for the management of gastric leaks in 2 patients after RYGB [20]. However, the published experience with these 2 devices is scarce, and more studies are needed.
Conclusion According to this initial series, the gastrojejunal aperture appears to have an effect on the symptoms of patients with intractable dumping syndrome. Additionally, endoscopic anastomotic reduction appears to be safe and could offer a minimally invasive treatment option for patients who experience intractable dumping symptoms after RYGB. Additional prospective studies with larger numbers of patients and more substantial follow-up are needed to confirm these early findings.
Disclosures G. Fernández-Esparrach was supported by a grant from Generalitat de Catalunya (AGAUR, BE-100022). The au-
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