Case series

Endoscopic full-thickness resection for gastrointestinal lesions using the over-the-scope clip system: a case series

Authors

Martin Fähndrich, Marcel Sandmann

Institution

Interventional Endoscopy, Department of Gastroenterology, Klinikum Dortmund, Dortmund, Germany

submitted 25. May 2014 accepted after revision 4. July 2014

The over-the-scope clip (OTSC) system was developed for the closure of gastrointestinal defects but can also be used for endoscopic resection. This report describes the efficacy and safety of endoscopic full-thickness resection (eFTR) using the OTSC system. In this retrospective, observational, open-label case study, a total of 17 patients underwent eFTR using a dual clip and cap technique. The indications were: carcinoids, incom-

pletely resected colon cancers involving the mucosa or submucosa, recurrent fibrosed adenoma of the colon, and submucosal lesions. The technical success was 94 % (16 /17). The complete resection (R0) rate was 100 %. There were no complications. In summary, the described minimally invasive method to perform eFTR of complex gastrointestinal lesions appears to be effective and safe.

Introduction

Results

!

!

The over-the-scope clip (OTSC) system was developed for the closure of gastrointestinal defects such as perforations and fistulas, and for the treatment of gastrointestinal bleeding [1 – 6]. The aims of this study were to evaluate the efficacy and safety of this technique for endoscopic fullthickness resection (eFTR) of endoluminal gastrointestinal tumors.

A total of 17 patients were included (8 men, 9 women; median age 57.65 years, range 21 – 85 years). The indications for endoscopic resection were: six carcinoids (one stomach, one duodenum, four rectum); seven R1 situations after conventional endoscopic polypectomy with low risk for colorectal cancer (two ascending colon, one descending colon, four sigmoid colon); three adenoma relapses (one each in the ascending, transverse, and sigmoid colon), and one submucosal lesion of the stomach (suspected gastrointestinal " Table 1, ● " Fig. 1). stromal tumors) (● In 16 cases, a combination of the OTSC system and the Inoue Cap for eFTR was used, and in one case the new full-thickness resection device (FTRD)" Table 1, ● " Fig. 1, ● " Fig. 2). The OTSC was used (● mean size of the lesions was 22.7 mm (range 10 – 25 mm). Application of the clips was successful in 16 /17 patients (94 % technical success). In one patient, the 14 /6 t OTSC did not deploy correctly. This patient underwent surgical resection of the " Table 1). A successful resection (endolesion (● scopic success) was accomplished in the remaining patients (16/16, 100 %). On final pathology, a full-thickness resection had been achieved in 11 patients (69 %). In five cases, a deep muscle margin (DMR) was present at the vertical margin of the resected specimen. Overall, a complete resection (R0) was achieved in all patients (16/16, 100 %).

Bibliography DOI http://dx.doi.org/ 10.1055/s-0034-1377975 Published online: 15.9.2014 Endoscopy 2015; 47: 76–79 © Georg Thieme Verlag KG Stuttgart · New York ISSN 0013-726X Corresponding author Martin Fähndrich, MD Interventional Endoscopy Department of Gastroenterology Klinikum Dortmund Beurhausstraße 40 44137 Dortmund Germany Fax: +49-231-95320510 martin.faehndrich@ klinikumdo.de

Patients and methods !

This was a retrospective, observational, open-label, single-arm, consecutive case study conducted at one advanced interventional endoscopy unit from May 2010 to May 2014. Patients with gastrointestinal lesions < 30 mm were included. Exclusion criteria were: patients < 18 years of age, pregnancy, failure to provide informed consent, and coagulopathy (international normalized ratio > 1.5, thrombocytes < 50 000 /μL). All patients provided informed consent to undergo endoscopy. All cases were performed using OTSCs (12 /6gc or 14 /6t; Ovesco, Tübingen, Germany). The endoscopic technique is described in the Supplementary Material (available online).

Fähndrich Martin et al. Endoscopic full-thickness resection using over-the-scope clips … Endoscopy 2015; 47: 76–79

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76

Case series

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Patient and lesion characteristic, and outcomes following endoscopic full-thickness resection using the over-the-scope clip system.

Sex

Age,

Location

Indication

years

Size,

Type of

Tech-

Techni-

Endo-

Compli-

OTSC

mm

OTSC1

nique

cal

scopic

cation

removal –

Histology

success

success

1

M

40

Rectum

Carcinoid

25

14 /6 t

1

Yes

Yes

No

Yes

Nd YAG DMR, R0 (pt1aN0L0V0R0)

2

M

25

Rectum

Carcinoid

25

14 /6 t

1

Yes

Yes

No

Yes

FTR, R0

3

F

68

Duodenum

Carcinoid

20

12 /6gc

1

Yes

Yes

No

Yes

FTR, R0

4

F

47

Stomach

Carcinoid

20

12 /6gc

1

Yes

Yes

No

Yes

DMR, R0

5

M

21

Rectum

Carcinoid

20

14 /6 t

1

Yes

Yes

No

Yes

DMR, R0

6

F

32

Rectum

Carcinoid

25

14 /6 t

1

Yes

Yes

No

Yes

FTR, R0

7

M

74

Sigmoid

R1 situation 2

20

14 /6 t

1

Yes

Yes

No

No (fell off)

DMR, R0

8

F

56

Sigmoid

R1 situation 2

25

14 /6 t

1

Yes

Yes

No

No (removed during surgery for another indication)

FTR, R0

9

F

85

Sigmoid

R1 situation 2

20

12 /6gc

1

Yes

Yes

No

No (died from other illness)

DMR, R0

10

F

80

Descending colon

R1 situation 2

25

14 /6 t

1

Yes

Yes

No

No (fell off)

FTR, R0

11

M

74

Ascending colon

R1 situation 2

25

14 /6 t

2

Yes

Yes

No

Yes

FTR, R0

12

F

60

Sigmoid

R1 situation 2

25

14 /6 t

1

Yes

Yes

No

Planned

FTR, R0

13

M

80

Ascending colon

R1 situation 2

25

14 /6 t

1

No









14

M

76

Sigmoid

Adenoma relapse

25

14 /6 t

1

Yes

Yes

No

No (fell off)

FTR, complete resection

15

F

67

Transversing colon

Adenoma relapse

25

14 /6 t

1

Yes

Yes

No

Yes

FTR, complete resection

16

M

70

Ascending colon

Adenoma relapse

25

14 /6 t

1

Yes

Yes

No

Planned

FTR, complete resection

17

F

25

Stomach

Submucosal lesion

10

12 /6gc

1

Yes

Yes

No

Yes

FTR, scattered spleen tissue

M, male; F, female; R1, incomplete resection; OTSC, over-the-scope clip; DMR, deep muscle resection; R0, complete resection; FTR, full-thickness resection. Secondary success: was defined as complete resection (R0). 1 All patients underwent a combination of the OTSC system and the Inoue Cap for eFTR (The Dortmund eFTR method), with the exception of patient #11 who underwent the procedure using the new full-thickness resection device prototype. 2 After conventional endoscopic polypectomy with low risk for colorectal cancer.

In nine patients, the OTSC was removed using Nd-YAG-laser, in three patients the OTSC fell off spontaneously, in three patients it remained attached (two patients were scheduled for clip removal, and one patient died because of other illness), and in one patient the OTSC was resected during surgery for another indication (left-sided colectomy for diverticulitis in a location different " Fig. 2). There were no complications from that of the clip) (● associated with sedation or the endoscopic procedure.

Discussion !

This study shows that the OTSC system is safe and feasible for eFTR and eDMR of gastrointestinal lesions up to 25 mm in diameter. A full-thickness resection was achieved in 69 % of cases (11 / 16), and DMR was accomplished in the remaining 5 patients (31 %). This method also achieved complete (R0) resection in all patients in whom clip deployment was successful, thus achieving the main aim of endoscopic resection. The technique does not re-

place existing methods but may become a useful addition to the therapeutic armamentarium of the interventional endoscopist. Another study on OTSC for endoscopic resection of gastrointestinal lesions was recently reported, and supports the concept that OTSC is useful for the safe endoscopic resection of complex gastrointestinal lesions [6, 7]. However, in the current study, larger amounts of tissue were resected using the 12 – and 14-mm diameter caps. Furthermore, an essential utility of OTSC for eFTR is the prevention of perforation and protection of the bowel before cutting. Indeed, when suctioning the tissue (including the muscle and serosa) into the cap and then releasing the clip, the endoscopist is already closing a potential perforation. A recent study from Japan showed that the OTSC was useful to close large defects and perforations after endoscopic submucosal dissection (ESD). We hereby propose that before a perforation occurs, an OTSC system can be applied to high-risk areas that have not yet been resected using ESD, allowing the remaining tissue to be safely resected above the clip, as shown in the current study and the previous study from the United States [6].

Fähndrich Martin et al. Endoscopic full-thickness resection using over-the-scope clips … Endoscopy 2015; 47: 76–79

This document was downloaded for personal use only. Unauthorized distribution is strictly prohibited.

Table 1

77

Case series

Fig. 1 a Endosonography (mini probe), 1-cm, low echo, submucosal lesion in the stomach. b The lesion base with the over-the-scope clip following endoscopic full-thickness resection (eFTR). c Resected lesion after eFTR. d Histology: scattered spleen tissue.

Endoloops have been used in endoscopy to strangulate and resect large lesions such as lipomas [8]; however, this technique causes strangulation necrosis. In contrast, the OTSC, a nitinol device, is a dynamic clip with strong apposition characteristics, but its use does not induce strangulation necrosis. A unique aspect of our experience in the current study was the availability of a resected colon specimen containing an OTSC. The patient underwent left-sided colectomy for diverticulitis in a location different from that of the clip, and this enabled the careful study of the gross and microscopic process of healing after clip application. On histology, a tissue bonding reaction initiated by migration of inflammatory " Fig. 2). cells and fibroblasts was evident (● Whereas an endoscopic resection can be performed by simply aspirating the tissue into the cap and then trapping it with the clip, we believe that an additional advantage of the combined technique of OTSC and Inoue cap, as used in the current study, is that the distal web of the Inoue cap may function as an electric insulation device, thus preventing contact of the resection snare with the exposed OTSC. In the present study, the removal of the released OTSC was easy using the Nd-YAG laser [9]. Whether it is necessary to remove all clips after implantation is debatable. We and others have shown that the OTSCs may fall off spontaneously [10]. In summary, the described minimally invasive method to perform endoscopic endoluminal resection of complex gastrointestinal lesions appears to be an effective and valid alternative to surgical resection. In addition, this method expands the currently available endoscopic resection techniques. Future studies comparing this technique with existing methods are warranted.

Endoscopic technique !

In 16 cases, endoscopic full-thickness resection (eFTR) was performed using a combination of the over-the-scope clip (OTSC) system (12 /6gc or 14 /6t; Ovesco, Tübingen, Germany) and the Inoue cap EMR kit (Olympus, Hamburg, Germany) (“Dortmund eFTR method”). In one case, the prototype full-thickness resection device (FTRD)-OTSC system was used (size 14 /6t; Ovesco).

The key steps of the Dortmund eFTR are as follows. 1) The lesion is pulled using the tissue grasping forceps (Rat tooth forceps; Cook Medical, Limerick, Ireland) into the distal cap of the OTSC. An important aspect of this technique is to avoid fitting too much of the cap over the distal end of the endoscope, as it is important to ensure that there is sufficient cap volume for the entrapment of tissue. 2) The OTSC is then released at the base of the pseudopolyp, thus tightly grasping the base and securing the bowel wall. 3) The scope is removed, the used OTSC cap is disconnected and the Inoue EMR resection cap is then loaded onto the scope. 4) The Inoue cap containing the snare is then directed onto the pseudopolyp. The cap should be placed exactly on top of the lesion. The snare is then used to trap the base of the pseudopolyp above the clip, and resection is then performed. The new FTRD prototype with a 14 /6 OTSC system is a combined system of cap, clip, and snare, which in theory permits an eFTR to be performed in a similar fashion to the Dortmund method. The snare is already in the open position and firmly linked to the cap and fixed outside of the endoscope. After deployment of the OTSC, the snare is tightened above the OTSC, and a smooth resection of the pseudopolyp is accomplished. All upper gastrointestinal procedures were performed with a double-channel gastroscope (Fujfilm, Tokyo, Japan). All lower gastrointestinal tract procedures were performed with a colonoscope (Fujfilm, Tokyo, Japan).

Definitions Technical success was defined as appropriate deployment of the OTSC. FTR was defined as the presence of all gastrointestinal wall components in the resected specimen. R0 was defined as free lesion margins. R1 was defined as incomplete resection of the target lesion. The procedures were performed by two dedicated therapeutic endoscopists (M.F., M.S.), who had previous experience with the OTSC system (10 cases of OTSC per endoscopist). All patients received a single dose of prophylactic antibiotic on the intervention day. For all eFTRs in the upper gastrointestinal tract, acid suppressive medication was administered for 14 days (pantozol 2 × 40 mg per os). All patients were kept fasting for 4 hours after the procedure, followed by a liquid diet for 1 day. A

Fähndrich Martin et al. Endoscopic full-thickness resection using over-the-scope clips … Endoscopy 2015; 47: 76–79

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regular diet was started on the following day. Every patient underwent ultrasound the day after the procedure and was clinically examined. Complications were divided into those related to sedation and those related to the endoscopic procedure.

5 6

Competing interests: None 7

References 1 Pohl J, Borgulya M, Lorenz D et al. Endoscopic closure of postoperative esophageal leaks with a novel over-the-scope clip system. Endoscopy 2010; 42: 757 – 759 2 Manta R, Manno M, Bertani H et al. Endoscopic treatment of gastrointestinal fistulas using an over-the-scope clip (OTSC) device: case series from a tertiary referral center. Endoscopy 2011; 43: 545 – 548 3 Sandmann M, Heike M, Fähndrich M. Application of the OTSC system for the closure of fistulas, anastomosal leakages and perforations within the gastrointestinal tract. Z Gastroenterol 2011; 49: 981 – 985 4 Mönkemüller K, Toshniwal J, Zabielski M et al. Utility of the “bear claw”, or over-the-scope clip (OTSC) system, to provide endoscopic hemosta-

8 9 10

sis for bleeding posterior duodenal ulcers. Endoscopy 2012; 44: E412 – E413 von Renteln D, Rösch T, Kratt T et al. Endoscopic full-thickness resection of submucosal gastric tumors. Dig Dis Sci 2012; 57: 1298 – 1303 Sarker S, Gutierrez JP, Council L et al. Over-the-scope clip-assisted method for resection of full-thickness submucosal lesions of the gastrointestinal tract. Endoscopy 2014: (in press) DOI 10.1055/s-00341365513 Nishiyama N, Mori H, Kobara H et al. Efficacy and safety of over-thescope clip: including complications after endoscopic submucosal dissection. World J Gastroenterol 2013; 19: 2752 – 2760 Raju GS, Gomez G. Endoloop ligation of a large colonic lipoma: a novel technique. Gastrointest Endosc 2005; 62: 988 – 990 Fähndrich M, Sandmann M, Heike M. Removal of over the scope clips (OTSC) with an Nd:YAG Laser. Z Gastroenterol 2011; 49: 579 – 583 Gutierrez JP, Sarker S, Wilcox M et al. “Clip and let go” for resection of duodenal carcinoid: a new technique using the over-the-scope-clip. Endoscopy 2014; 46: E61

Fähndrich Martin et al. Endoscopic full-thickness resection using over-the-scope clips … Endoscopy 2015; 47: 76–79

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Fig. 2 a Resection of the sigmoid with the overthe-scope clip in situ following full-thickness resection. b The lesion after fixation in formalin. c Cutting through the remaining base. d Invagination of fatty tissue. e Histology of the invaginated fatty tissue. f Migration of neutrophilic granulocytes.

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Endoscopic full-thickness resection for gastrointestinal lesions using the over-the-scope clip system: a case series.

The over-the-scope clip (OTSC) system was developed for the closure of gastrointestinal defects but can also be used for endoscopic resection. This re...
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