Endoscopic management for gastrointestinal leaks, perforations, and fistulae: Technical tips and outcomes

Table 1 Characteristics of available through the scope clips

Clip	Manufacturer	Opening diameter (mm)	Jaw length (mm)	Stem length (mm)	Material	Rotation
Resolution 360	Boston Scientific; United States	11 and 17	9	7	Stainless steel, Cobalt	360°
Instinct1	Cook Medical; United States	11 and 16	9	6	Stainless steel, Nitinol	Scope position dependent
Quick clip pro1,2	Olympus Medical; Japan	11	10	5	Elgiloy	Scope position dependent
Dura clip	ConMed; United States	11 and 16	7	3	Stainless steel	360°
Sure clip	Micro-Tech Endoscopy; United States	8, 11 and 16	11	3	Stainless steel	360°
Medorah	Medorah Meditek; India	11, 13 and 16	9	3	Stainless steel	360°

¹Highest compression strength.

²Highest lateral tissue manipulation strength.

Table 2 Techniques of the clip and line/Loop strategy for closure

Technique	Auxiliary instruments	Procedure details	Pros	Cons
Loop-clip closure	Loop–clip: Consists of a loop of nylon string attached to a metallic clip	Loop-clip device is fixed to the edge of the defect at the mid of distal side. Then, another TTSC is passed to hook and pull the loop to fix on the proximal defect margin. Afterwards, the complete closure is achieved by the use of regular TTSC	Suitable for large defects. Applicable for all GI segments. No need for a double-channel scope. No need for scope withdrawal and reinsertion	Need for a special device
Clip-band closure	Clip-band device: 3 interconnected elastic silicon bands (two 3.3 mm rings and one 15 mm ring) preloaded on the clip	The clip-band device is fixed to the edge of the defect at the distal side. Then, another TTSC is passed to hook and pull the band to fix on the proximal defect margin. Afterwards, the same clip-band sequence or standard TTSC can be applied to achieve complete closure
Endoscopic sliding closure	Ring-shaped surgical thread (8, 10 and 12 mm diameter)	The ring thread is clipped at two points across the maximum diameter of the defect margins. A third clip then grasps one side of the ring thread and then draws across the opposite end to bring the clips and defect margins closure. The process can be repeated at 2-3 sites, depending on size. Subsequently, complete closure can be achieved by the standard TTSC
Clip-line closure	Long nylon line tied on the arm of the endoclip	Endoclip (with attached nylon line on one arm) is fixed to healthy mucosa 5 mm from the defect margin on one side. The other side of the defect margin, along with the line, is then anchored by another endoclip. Both the defect margins, along with clips, are approximated by gentle pulling of the line. Further, additional clips with/without lines are placed to achieve complete closure
Ring/king closure	Detachable endoloop	The apex of the detachable endoloop is fixed to one edge of the defect using an endoclip. With the help of multiple clips, the loop is garlanded to the defect margins. The loop is tightened to close the defect in a purse-string manner
ROLM	Muscle layer grasping clips, a reopenable clip, and nylon line	Reopenable clip with a nylon line fixed on it clips the normal mucosa and muscle layer of the distal side of the defect margin. The end of the line exiting through the accessory channel of the endoscope is passed through the hole in one tooth of the second reopenable clip. This second clip with the line (ROLM) is placed on the opposite side of the defect, and the muscle layer is being grasped by the tooth through which the line has been passed. Repeating ROLM gradually closes the defect from the distal to the proximal side	Suitable for thick-walled sections of GI tract defects like gastric and rectal defects (risk of dead space with conventional closure methods). Teeth of the reopenable clips through which nylon line passes are continuously fixed by the line, preventing the clips from being buried into the muscle layer side	Need for muscle layer grasping clips, reopenable clips, and a nylon line

GI: Gastrointestinal; OTSC: Over the scope clips; ROLM: Re-openable clip on the line method; TTSC: Through the scope clips.

Table 3 Outcomes of through the scope clips and over the scope clips in the management of gastrointestinal tract defects

Ref.	Study design	Population characteristics	Outcomes in the clip cohort	Outcomes in control cohort	Additional information
Kirschniak et al[29], 2011	Retrospective	n = 50, GI Bleed: n = 27. Perforation: n = 11. Fistulae: n = 8. Pre-op marking: n = 4	Primary success: 100%. Recurrence of GI bleed: 2 (7.4%). Recurrence of fistulae: 5 (62.5%). No recurrence of perforation	NA	High recurrence of fistulae despite initial success
Hagel et al[34], 2012	Prospective	n = 17 (Iatrogenic perforations: n = 6. AL: n = 3. Complication of PEG: n = 5. Duodenal ulcer perforation: n = 3). Median age: 71 ± 7 years	Successful closure: 11 (64.7%)	NA	Six unsuccessful cases had larger perforation defects and had necrotic or soft inflammatory margins
Voermans et al[33], 2012	Prospective, multicenter	n = 36. Acute iatrogenic perforations. Location: Esophageal: n = 5. Gastric: n = 6. Duodenal: n = 12. Colonic: n = 13. M: 15; F: 21	Successful closure: 33 (92%). Clinical success: 32 (89%). Surgery: n = 4. Death: n = 1	NA	Death occurred in one patient with colonic perforation (even after surgery)
Lee et al[13], 2013	Retrospective	35 patients with AL after surgery for gastric cancer. M: n = 27, F: n = 8. Median age: 64 Y	n = 20. Technical clinical success: 19 (95%). Surgery due to failed endoscopic t/t: n = 1. Death: n = 0	n = 15. Death: n = 5. Cause of death: Sepsis, bleeding, HAP	Endoscopic modality: Hemoclips: n = 17. Detachable snare: n = 2. Additional fibrin glue: n = 14
Haito-Chavez et al[35], 2014	Multicenter, retrospective	n = 188. Fistulae: n = 108. Perforations: n = 48. AL: n = 32	Overall success: 60.2%. Success rate for perforations: 90%. Success rate for AL: 73.3%. Success rate for fistulae: 42.9%	NA	Success rate is significantly higher for acute defects (like perforations/AL) than for chronic defects (fistulae). Success rate is significantly higher if OTSC is applied for primary therapy (69.1%) than for rescue therapy (46.9%; P = 0.004)
Law et al[37], 2015	Retrospective	n = 47. Mean age: 57 ± 14. M: 24; F: 23. Fistula location: Esophagus: n = 3. Stomach: n = 16. Small bowel: n = 18. Colo-rectum: n = 10	Initial technical success: 42 (89%). Fistula recurrence: 25 (53%) at median f/u of 178 days	NA	Poor long-term outcomes of OTSC: Fistula recurrence around 50% despite OTSC retention
Verlaan et al[14], 2015	SRMA	24 studies; 21 retrospective, 3 prospective, no RCT. n = 466 Hemoclips: n = 398. OTSC: n = 66. Stents: n = 2	Successful outcome: 419 (89.9%). Success rate of hemoclips: 359 (90.2%). Success rate of OTSC: 58 (87.8%). Success rate of stents: 2 (100%)	NA	Limited by the low methodological quality of included studies
Kobara et al[39], 2019	SRMA	30 studies. n = 1517	Clinical success rate: For perforation: 85% (n = 351). For AL: 66% (n = 97). For fistulae: 52% (n = 388)	NA	Overall complications: 1.7% (n = 23). Severe complications: 0.59% (n = 9)

AL: Anastomotic leak; HAP: Hospital-acquired pneumonia; F: Female gender; F/u: Follow-up; M: Male gender; NA: Not available; OTSC: Over the scope clips; PEG: Percutaneous endoscopic gastrostomy; Pre-op: Pre-operative; RCT: Randomised control trial; SRMA: Systematic review and meta-analysis; t/t: Treatment.