Over-the-scope clip for endoscopic closure of gastrogastric fistulae

Surgery for Obesity and Related Diseases ] (2016) 00–00

Original article

Over-the-scope clip for endoscopic closure of gastrogastric fistulae Benjamin Niland, M.D.a,*, Andrew Brock, M.D.b b

a Department of Medicine, Medical University of South Carolina, Charleston, South Carolina Division of Gastroenterology and Hepatology, Medical University of South Carolina, Charleston, South Carolina Received March 5, 2016; received in revised form June 2, 2016; accepted August 2, 2016

Abstract

Background: Gastrogastric fistulae (GGF) are a well-known complication of Roux-en-Y gastric bypass (RYGB). Endoscopic approaches for closure of GGF have gained popularity, but with limited data and efficacy. Objectives: The primary arm of the study was to evaluate the safety and efficacy of the endoscopic closure of GGF using the over-the-scope clip (OTSC) device. Setting: University hospital, United States Methods: This is a retrospective review of consecutive patients at a single academic center from September 2013 to December 2014 who underwent upper endoscopy with attempted OTSC placement for closure of GGF related to RYGB. Preprocedural, procedural, and postprocedural data were collected. Outcome measures included technical success, primary success, and long-term success. Results: A total of 14 patients underwent attempted GGF closure using OTSC. Twelve of the 14 patients (85.7%) had technical success. Four patients were lost to follow-up. Primary success was achieved in 5 of the 10 patients (50%) in which it was assessed, either by upper gastrointestinal series or endoscopy. One of the 5 patients who had primary success was then lost to follow-up. Of the 4 patients in whom primary success was achieved and had long-term follow up, 75% (n ¼ 3) achieved long-term success at a mean follow-up of 6.6 months from initial OTSC placement (range, 3–9), making for a long-term success rate of 33% (3/9). There were no reported complications. Conclusion: OTSC closure of small GGF is feasible, safe, and offers a reasonable alternative to surgical revision. Large GGF may undergo attempted endoscopic closure, acknowledging a high failure rate. (Surg Obes Relat Dis 2016;]:00–00.) r 2016 American Society for Metabolic and Bariatric Surgery. All rights reserved.

Keywords:

Ovesco; over-the-scope clip; GGF; gastrogastric fistula; gastrogastric fistulae

Gastrogastric fistulae (GGF) are a well-known complication of Roux-en-Y gastric bypass (RYGB), occurring in 1.2 to 6% of cases [1,2]. When symptomatic, they can lead to weight regain, abdominal pain, gastroesophageal reflux disease, and ulcer formation at the gastrojejunal (GJ) anastomosis. GGF can sometimes be managed conservatively, but often require more invasive therapy [2,3]. Though no optimal management strategy *

Correspondence: Benjamin Niland, M.D., 96 Jonathan Lucas Street, Suite 803, MSC 623, Charleston, SC 29425. E-mail: [email protected]

exists, surgical revision remains the standard of care, yet it is technically difficult and has a higher morbidity than primary bariatric surgery [4,5]. Endoscopic approaches have gained popularity in the treatment of GGF owing to their safety, but most approaches, such as through-the-scope clips, have limited long-term efficacy, particularly with fistulae 41 cm in size [6]. In recent years, a novel over-the-scope-clip (OTSC; Ovesco, Tübingen, Germany) has shown promise in the treatment of a variety of gastrointestinal defects including fistulae [7,8]. However, there is a paucity of literature on its

http://dx.doi.org/10.1016/j.soard.2016.08.005 1550-7289/r 2016 American Society for Metabolic and Bariatric Surgery. All rights reserved.

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B. Niland & A. Brock / Surgery for Obesity and Related Diseases ] (2016) 00–00

use in the management of GGF. The aim of this study was to evaluate the safety and efficacy of the endoscopic closure of GGF using the Ovesco clip. Methods This is a retrospective review of consecutive patients at a single academic center from September 2013 to December 2014 who underwent upper endoscopy with attempted OTSC placement for closure of GGF related to RYGB. This study was approved by the Institutional Review Board of the institution. Study patients All patients undergoing esophagogastroduodenoscopy (EGD) for attempted closure of GGF by OTSC were included in the study. Cases were identified by retrospective review of the electronic medical record and endoscopy database. Data collected included patient demographic characteristics, date of RYGB, presenting complaint that prompted suspicion for the presence of a GGF, time elapsed between clinical diagnosis of GGF and attempted OTSC placement, and any previous attempts at repair. Procedural data included fistula size, number of OTSC’s applied, other therapies rendered, technical success, procedure time, and adverse events. Postprocedural data consisted of type and duration of follow-up, primary success, long-term success, and need for further intervention. Outcome measures Technical success was defined as successful closure of the fistula at the time of endoscopy, based on visual inspection. Primary success was defined as absence of oral contrast passage into the excluded stomach on upper gastrointestinal series (UGIS) or absence of fistula seen on subsequent endoscopy. Long-term success was defined as status of the fistula as seen on most recent imaging (endoscopic or radiographic). Endoscopic technique All procedures were performed with the Olympus GIF-1 TQ160 gastroscope (Olympus Medical, Center Valley, PA). The 12/6 gc OTSC (Ovesco, Tübingen, Germany) was used in all cases. The OTSC Twin Grasper (Ovesco, Tübingen, Germany) was used to aid in tissue approximation at the discretion of the endoscopist. Tissue apposition was deemed adequate without this device in all but one patient. All procedures were performed under monitored anesthesia care (MAC) or general anesthesia.

Results Fourteen patients underwent upper endoscopy for consideration of OTSC placement for GGF closure after RYGB and OTSC closure was attempted in all 14 (Table 1). Mean age was 54 years (range, 46–67) and 78% were female (Table 2). The most common presenting complaints were abdominal pain (n ¼ 7) and nausea/vomiting (n ¼ 6). GGF was diagnosed by UGIS, computed tomography (CT) imaging, and or EGD. Mean time elapsed from initial bypass surgery to clinical diagnosis of fistula was 9.4 years (range, 0–38 years). Mean time elapsed from clinical diagnosis of fistula to OTSC placement was 16 months (range, 0–68 months). Mean procedure time was 24 minutes (range, 11–56). Mean fistula size was 7.2 mm (range, 3–15). Twelve of the 14 patients had technical success (85.7%). Four of the 14 patients were lost to follow-up after endoscopy, preventing assessment of primary and longterm success. Of the 10 patients who followed-up after OTSC placement, primary success was achieved in 50% (n ¼ 5). Eight of the 10 patients had primary success determined by UGIS and 2 by EGD. All 5 patients who achieved primary success were verified by UGIS. Mean time to primary success follow-up was 28.5 days (range, 1–120). One of the 5 patients who had primary success was then lost to follow-up. Of the 4 patients in whom primary success was achieved and had long-term follow up, 75% (n ¼ 3) achieved long-term success at a mean follow-up of 6.6 months from initial OTSC placement (range, 3–9), making for a long-term success rate in the 9 patients for whom we had follow-up data 33% (3/9). Only 1 patient underwent additional therapies at the time of OTSC placement; patient 11 underwent argon plasma coagulation (APC) before OTSC placement. Of the 14 patients who underwent attempted GGF closure via OTSC, 3 had undergone prior bariatric revision surgery, 2 of which were for GGF. One patient underwent 2 surgical revisions for GGF before OTSC placement. Another patient underwent sclerotherapy with sodium morrhuate before surgical revision. Of the 3 patients who underwent surgical revision before attempted OTSC placement, 2 had both primary success and long-term success with OTSC use. The other patient had primary and long term success with OTSC use in only 1 of 2 GGF. Three patients underwent multiple endoscopic attempts for fistula repair with OTSC placement. There were no reported complications of OTSC placement for any patient.

Discussion Statistical analysis Technical success, primary success, and long-term success were calculated.

Gastrogastric fistulae remain a challenge, regardless of therapeutic modality utilized. Recent endoscopic developments have offered an attractive alternative to surgery given

Patient Presenting Symptoms

Time between surgery and fistula diagnosis (yr)

Prior therapies

Time between diagnosis and GGF size Procedure Primary OTSC placement (mos) (mm) time (mins) success

Recurrence

Length of long-term follow up (mos)

1

Yes (although closure ultimately obtained) Yes (multiple attempts) No Yes

8

7 2

No Yes

None 1.5

No

9

.67

None

3

10

13

Yes

2

Nausea, vomiting, abdominal pain Abdominal pain

10

None

6

12

20

No

3 4

Abdominal pain Abdominal pain

0 3

None Two surgical revisions

1 3

10 3;3

18 56

5 6

Abdominal pain Nausea, vomiting, abdominal pain, weight loss Nausea, vomiting, abdominal pain Nausea, vomiting

7 8

None None

60 3

3 15

11 38

Yes No; 1 small leak Yes No

1

Surgical revision

24

4

22

Yes

12

GJ stricture dilation; no prior 1 intervention on fistula None 36

3

26

Unknown Unknown

None

11

16

Unknown Unknown

None

None None None Sclerotherapy with sodium morrhuate; surgical revision None

24 3 3 4

8 4 5 Unknown

24 15 33; 45; 12 25

Unknown Unknown No Yes

Unknown None Unknown None Yes (multiple fistulas) 10 No 3

o1

10

21; 14; 24

No

Yes (multiple attempts)

7 8 9 10 11 12 13 14

Nausea, vomiting, abdominal pain Weight gain Weight gain Heartburn Nausea, vomiting Abdominal pain, heartburn

13 38 7 11 5 10

GGF ¼ gastrogastric fistula(e); GJ ¼ gastrojejunal; mm ¼ millimeters; mins ¼ minutes; mos ¼ months; OTSC ¼ over-the-scope clip; yr ¼ years.

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Over-the-Scope Clip for Gastrogastric Fistulae / Surgery for Obesity and Related Diseases ] (2016) 00–00

Table 1 Study results

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B. Niland & A. Brock / Surgery for Obesity and Related Diseases ] (2016) 00–00

4 Table 2 Patient demographic characteristics Characteristic Age, yr (range) Mean Gender, n (%) Female Male Ethnicity, n (%) black Caucasian

Value 54 (46–67) 11 (78.6) 3 (21.4) 5 (35.7) 9 (64.3)

n ¼ number; yr ¼ year.

their safety profile, though all have limitations, particularly with fistulae 41 cm in size. Initial attempts at endoscopic therapy for GGF involved the use of tissue anchors, fibrin sealant, early endosuturing devices, and through-the-scope (TTS) clips [6,9–13]. All had limited success, likely due to a lack of full tissue closure; thus, even with small fistulae primary closure may fail or recurrences may occur [6,9]. The OTSC was developed for the treatment of gastrointestinal defects, including fistulae, leaks, and acute perforations [14]. The major advantage over TTS clips is the large diameter and grasping force [15]. One study found full-thickness closure of defects of as large as 27 mm in porcine models [16]. A recent multinational, multicenter retrospective study reported 42.9% success rate for OTSC closure of fistulae. Of the 108 patients in the study with fistulae, an unspecified amount were gastrogastric in nature [7]. There have been reports of closure of gastric staple line leaks and fistulae after sleeve gastrectomy with OTSC use [17,18]. Other literature involving closure of GGF with OTSCs are limited to case reports [8,19]. In this study, we found a 33% (3 of 9) long-term closure rate for GGF using the OTSC, with no complications. This is similar to other small studies evaluating GGF closure with TTS placement with long-term closure rates of 24%– 50% [6,9]. This is much lower than long-term closure rates documented for surgical revision of GGF, which is 100% [20,21]. Fistula size appears to be a major determinant of endoscopic closure success. In our study, 4 of the 5 unsuccessful fistula closures were Z10 mm, and the fifth was measured only radiographically with an estimated size of 5 mm. Several other factors may have contributed to a lower than anticipated long-term success rate in this study. All patients in this study who underwent endoscopy for potential closure of GGF did undergo an attempt at GGF closure with OTSC. Other proceduralists may choose to be more selective of fistulae that they attempt to close with the OTSC device. Alternative methods of closure in selected larger and or more difficult fistulae would likely increase the long-term closure success rate. One approach for larger

fistulae is to use an endoscopic suturing system such as the OverStitch Endoscopic Suturing System (Apollo Endosurgery, Inc. Austin, Texas, USA). This device was not available at our institution at the time of this study. Another major point of consideration is the relative lack of use of adjunctive modalities used during endoscopy for OSTC placement in this study. Only 1 of the 14 patients underwent adjuvant endoscopic treatment modalities at the time of OTSC placement—1 patient underwent argon plasma coagulation (APC) as well as the use of the Twin Grasper before over-the-scope clip placement. Certain adjunctive devices to OTSC such as the OTSC Twin Grasper or OTSC Anchor (Ovesco Endoscopy AG) were invented to aid in tissue approximation. These devices may help to better grasp fibrotic tissue and bring the entire defect opening into the cap before firing. Some authors also advocate for the use of APC to ablate the fistula tract whenever it is safe to do so. This strategy may allow for a more complete and deeper tissue approximation, thereby increasing long-term success rates [22]. This was not done in our patients over concern of further degrading the fistulous tract, though it should be noted that we may have had higher success rates if this strategy was employed. Fluoroscopy during endoscopy to evaluate for peri-clip leaks is another measure that could be employed to potentially increase success rates. This may allow for immediately identifying a technical failure that may be amenable to additional OTSC placement attempts during the same endoscopy. Fluoroscopy was not used during endoscopy in the patients included in this study. Endoscopic closure of GGF using the over-the-scope clip device appears to be a viable alternative to surgical revision. Even if endoscopic closure fails, one can proceed with surgery thereafter. Prior attempts at endotherapy have been shown to not affect surgical outcomes [23]. However, it should be stated that OTSC have a long and unpredictable dwell time. Before revision surgery, one must ensure that the clip is no longer present in the operative space as a stapler will not fire through it. In addition to surgery being a safe and viable option after OTSC placement, the opposite may be true as well. In our study 2 of the patients with long-term success had prior revision surgery performed. This suggests that endoscopic repair of GGF may be a viable option even after surgical revision procedures. Of the 3 patients who underwent multiple attempts at endoscopic repair, 1 had long-term success after 2 attempts with OTSC placement and a third attempt with TTS clip placement. This suggests that multiple attempts at endoscopic repair of GGF may be reasonable before proceeding to surgical revision, and that multiple attempts at endoscopic closure may be necessary for long-term success. Some authors have advocated for this approach in the literature to avoid open surgery in this patient population

Over-the-Scope Clip for Gastrogastric Fistulae / Surgery for Obesity and Related Diseases ] (2016) 00–00

[22]. In one of the other patients who underwent multiple attempts at endoscopic repair, 1 GGF was closed with OTSC placement; however, an additional GGF was unable to be closed. Of the 3 patients with multiple GGF, 1 of the 3 had successful closure of all fistulas at last follow-up. Both of the other patients had successful closure of at least one of their fistulas on last follow-up. It is unclear if the presence of 4 1 GGF is indicative of worse endoscopic outcomes. Two of the 14 patients in this series had a concomitant GJ stricture. Of the 2 patients, 1 had failure of GGF repair. The other patient underwent GJ dilation before GGF repair. The patient was then lost to follow-up. One would suspect that the presence of a GJ stricture would make closure of a GGF more difficult and that treatment of the stricture before GGF repair would increase long-term GGF closure success. This study has several limitations, including the retrospective design and small number of patients. Additionally, there was no uniform documentation of the size, location, and appearance of fistulae. There was also no uniform follow-up protocol and 5 of the 14 patients had no longterm follow-up data. Increasing both the length and amount of follow-up (clinical, radiographic, and endoscopic) may have identified a higher number of recurrent GGF. Another potential limitation is that we used the Ovesco 12/6 gc in all circumstances. This version of the OTSC is useful for gastric fistulae due to the long, thin teeth, which is why we used it in all of our patients [24]. As noted previously, the lack of use of adjuvant therapies during OSTC placement and fluoroscopy at the time of OSTC placement are limitations of this study; when used routinely, they may improve success rates and better identify technical failures that could be immediately intervened upon respectively. Overall, larger trials are needed to help answer these questions and further evaluate the safety and effectiveness of over-the-scope clip use as endoscopic treatment of gastrogastric fistulae. Conclusion OTSC closure of small GGF is feasible, safe, and offers a reasonable alternative to surgical revision. If it fails, surgery remains an option. Large GGF (41 cm) may undergo attempted endoscopic closure, acknowledging a high failure rate. Disclosures The authors have no commercial associations that might be a conflict of interest in relation to this article. References [1] Cucchi S, Pories W, MacDonald K, Morgan E. Gastrogastric fistulas. A complication of divided gastric bypass surgery. Ann Surg 1995;221 (4):387–91.

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