Outcomes of gastrointestinal defect closure with an over-the-scope clip system in a multicenter experience: An analysis of a successful suction method

Table 1 Demographics and characteristics of patients, defects, and over-the-scope clips

Characteristics	Details	Total patients (n = 58)
Age, median (range), yr		77 (37-98)
Indications, n
Refractory bleeding		18
	Ulcer (peptic, Behçet's, anastomosis)	12
	Mallory-Weiss tear	1
	Diverticula	2
	Post-endoscopic resection	3
Leaks		28
	Peptic ulcer	3
	Boerhaave	1
	Iatrogenic (ESD)	16
	Iatrogenic (ERCP)	2
	Iatrogenic (surgery)	4
	Iatrogenic (other)	2
Fistula		12
	PEG	6
	Rectum-bladder	1
	Rectum-pelvis	2
	Gastric tube-trachea	1
	Gastric-pseudopancreatic cyst	1
	Colon-gallbladder	1
Location, n
Esophagus		3
Stomach		28
Duodenum		13
Small intestine		2
Colon		12
Maximum defect size (D) mm, n
D ≤ 10		25
10 < D ≤ 20		9
20 < D		24
Median (range), mm		15 (3-50)
Duration since onset to OTSC placement, n
Immediate ≤ 1 d		25
1 < Acute ≤ 7 d		11
Chronic > 7 d		22
Suction method into the applicator cap
Simple suction		14
Twin Grasper (TG) assist		42
Anchor assist		2
The number of OTSC deployments, n
0		21
1		39
2		12
3		5

¹Procedural inability. OTSC: Over-the-scope clip; PEG: Percutaneous endoscopic gastrostomy; ERCP: Endoscopic retrograde cholangiopancreatography; SS: Simple suction; TG: Twin Grasper.

Table 2 Results of major outcomes

Outcomes	Total patients (n = 58)
Technical success rate, % (95%CI)	89.7 (81.0-98.4)
Clinical success rate, % (95%CI)	84.5 (74.3-94.7)
Complications, n (%)	1 (1.8) in 56 cases used
The procedure time, median (range), min	8 (1-36) in 52 successful cases

Table 3 Results of the technical and clinical success rates for each parameter

Parameters	Total patients (n = 58)
	Technical success rate	Clinical success rate
Indications
Refractory bleeding	88.9 (16/18)	83.3 (15/18)
Leak	89.3 (25/28)	85.7 (24/28)
Fistula	91.7 (11/12)	83.3 (10/12)
Location
Upper GI tract	86.4(38/44)	81.8 (36/44)
Lower GI tract	100 (14/14)	92.9 (13/14)
Maximum defect size (D), mm
D ≤ 10	96 (24/25)	84 (21/25)
10 < D ≤ 20	88.9 (8/9)	88.9 (8/9)
20 < D	83.3 (20/24)	83.3 (20/24)
Duration since onset, % (n)
Immediate ≤ 1 d	96 (24/25)	96 (24/25)
1 < Acute ≤ 7 d	90.9 (10/11)	81.8 (9/11)
Chronic > 7 d	81.8 (18/22)	72.7 (16/22)
Suction method into the applicator cap
Simple suction (SS)	100 (14/14)	78.6 (11/14)
Twin Grasper (TG) Anchor assist	88.1 (37/42) 50 (1/2)	88.1 (37/42) 50 (1/2)
The number of OTSC deployments, n
1	92.3 (36/39)	84.6 (33/39)
2	100 (12/12)	100 (12/12)
3	80 (4/5)	80 (4/5)

Table 4 Outcomes of the simple suction and Twin Grasper methods n (%)

Parameters	SS-method (n = 14)	TG-method (n = 42)	P value
Technical success rate	14 (100)	37 (88.1)	0.1761
Clinical success rate	11 (78.6)	37 (88.1)	0.3781
Procedure time, median (range), min	5 (1-16)	12 (3-36) in 37 successful cases	0.00042
Complications	0 (0)	1 (2.4)	0.5871

¹Fisher's exact test (2-sided),

²Wilcoxon/Kruskal-Wallis test. SS: Simple suction; TG: Twin Grasper.

Table 5 Results of the technical and clinical success rates of the simple suction- and Twin Grasper-groups for each parameter

Parameters	Technical success rate			Clinical success rate
	SS (n = 14)	TG (n = 42)	P value1	SS (n = 14)	TG (n = 42)	P value1
Indication
Refractory bleeding	100 (7/7)	81.8 (9/11)	0.2315	85.7 (6/7)	81.8 (9/11)	0.8288
Leak	100 (2/2)	92 (23/25)	0.6776	50 (1/2)	92 (23/25)	0.0690
Fistula	100 (5/5)	83.3 (5/6)	0.3384	80 (4/5)	83.3 (5/6)	0.8865
Location
Upper GI tract	100 (8/8)	85.3 (29/34)	0.8725	75 (6/8)	85.3 (29/34)	0.8725
Lower GI tract	100 (6/6)	100 (8/8)		83.3 (5/6)	100 (8/8)	0.2308
Maximum defect size (D), mm
D ≤ 10	100 (14/14)	100 (9/9)		78.6 (11/14)	100 (9/9)	0.1364
10 < D ≤ 20	-	88.9 (8/9)	-	-	88.9 (8/9)	-
20 < D	-	83.3 (20/24)	-	-	83.3 (20/24)	-
Duration since onset, % (n)
Immediate ≤ 1 d	100 (3/3)	95.5 (21/22)	0.6994	100 (3/3)	95.5 (21/22)	0.6994
1 < Acute ≤ 7 d	100 (3/3)	87.5 (7/8)	0.1247	66.7 (2/3)	87.5 (7/8)	0.1247
Chronic > 7 d	100 (8/8)	75 (9/12)	0.1250	75 (6/8)	75 (9/12)	1.0000

¹χ² test (2-sided). SS: Simple suction; TG: Twin Grasper.

Table 6 Comparison of the clinical success rates for the combined parameters in each indication

	Clinical success rate
Indications	Refractory bleeding (n = 18)		Leak (n = 27)		Fistula (n = 11)
Combined parameters	SS (n = 7)	TG (n = 11)	SS (n = 2)	TG (n = 25)	SS (n = 5)	TG (n = 6)
D ≤ 10, Immediate	100%	100%	-	100%	-	-
D ≤ 10, Acute	100%	-	50%	100%	-	-
D ≤ 10, Chronic	66.7%	100%	-	-	80%	100%
10 < D ≤ 20, Immediate	-	100%	-	66.7%	-	-
10 < D ≤ 20, Acute	-	100%	-	100%	-	-
10 < D ≤ 20, Chronic	-	100%	-	-	-	100%
D > 20, Immediate	-	100%	-	100%	-	-
D > 20, Acute	-	-	-	75%	-	-
D > 20, Chronic	-	33.3%	-	-	-	50%

SS: Simple suction; TG: Twin Grasper.

Table 7 Details of over-the-scope clips clinical failure cases (n = 8)

Indication	Max. defect size, mm	Cause, comorbidity	Location	Prior therapy	Duration since onset	Technical success	Technical or clinical failure factor	Additional therapy	Clinical outcome
Refractory bleeding	8	Ileal ulcer bleeding due to steroid treatment for myelodysplastic syndrome	Terminal ileum	EI (hemoclips and coagulation)	Chronic	Yes	Suspicion of angiogenesis due to steroid in particular circumstances	Elective surgery	Survival
Refractory bleeding	20	Peptic ulcer, Refractory neurogenic disease	Stomach (body)	EI (coagulation)	Chronic	No	Fibrotic tissue	Retry of EI	Survival
Refractory bleeding	50	Peptic ulcer, Advanced gallbladder carcinoma	Stomach (body)	EI (coagulation)	Chronic	No	Fibrotic tissue	Retry of EI	Survival
Leak	7	Anastomotic leakage after surgery for gastric cancer	Esophageal gastric junction	None	Acute	Yes	Leakage by mucosal suture (suspected)	Elective surgery	Survival
Leak	21	Perforation during ERCP	Duodenal 2nd portion	None	Immediate	No	Inability of platform	Emergency surgery	Survival
Leak	50	Delayed perforation after ESD	Stomach (prepyrolus)	None	Acute	No	Location with narrow lumen	Elective surgery	Survival
Fistula	8	Interventional EUS	Gastric (prepyrolus)- pseudopancreatic cyst	None	Chronic	Yes	Leakage by mucosal suture (suspected)	Elective surgery	Survival
Fistula	22	Radiation for esophageal carcinoma	Gastric tube-trachea	Bronchial embolization	Chronic	No	Fibrotic tissue	Elective surgery	Survival

SS: Simple suction; TG: Twin Grasper; EI: Endoscopic intervention; ERCP: Endoscopic retrograde cholangiopancreatography; EUS: Endoscopic ultrasound.

Table 8 Current clinical outcomes of over-the-scope clips for each indication

Ref.	Year	Country	Patients (n)	Overall clinical success rate, (success/ total)					Mean defect size (mm)	Described data of suction method	Complications, n (%)
				Refractory bleeding	Leaks and/or perforations	Fistula	Others	Total
Albert et al[20]	2011	Germany	19	57.1 (4/7)	87.5 (7/8)	25 (1/4)	-	63.2	Unknown	Unknown	0
Surace et al[21]	2011	France, Monaco	19	-	-	74 (14/19)	-	73.7	Unknown	Unknown	1 (5)
Kirschniak et al[22]	2011	Germany	50	92.6 (25/27)	100 (11/11)	37.5 (3/8)	100 (4/4)	86	6	Unknown	0
Baron et al[19]	2012	United States	45	100 (7/7)	62.5 (5/8)	67.9 (19/28)	50 (1/2)	71	Unknown	TG: 8 cases AC: 17 cases	2 (4.4)
Manta et al[23]	2013	Italy	30	90 (27/30)	-	-	-	90	Unknown	Unknown	0
Haito-Chavez et al[15]	2014	International2	188	-	Leaks 73.3 (22/30), 21 Perforations 90 (36/40), 81	42.9 (39/91), 171	-	60.2	Leaks: 8 Perforations: 7 Fistula: 5	Use of TG and/or AC, 50% (70/140 cases)3	0
Law et al[24]	2014	United States	47	-	-	53 (25/47)	-	53	Unknown	Unknown	0
Sulz et al[25]	2014	Switzerland	21	100 (1/1)	66.7 (4/6)	63.6 (7/11)	100 (3/3)	71.4	8	SS:4 100% (10/10) TG:100% (1/1) AC: 87.5% (7/8) TG + AC: 0% (0/1)	0
Mercky et al[26]	2015	France, Monaco	30	-	-	53 (16/30)	-	53	7.2	SS: 17 procedures TG: 9 procedures AC: 5 procedures	4 (13.3)
Our study	2016	Japan	58	83.3 (15/18)	85.7 (24/28)	83.3 (10/12)	-	84.5	19.6	CSR SS4: 78.6% (11/14) TG: 88.1% (37/42) AC: 50% (1/2)	1 (1.8)
Total			507	87.8 (79/90)	83.2 (109/131)	53.0 (133/251)	88.9 (8/9)	68.4 (329/481)			8/481 (1.66)

¹Excluded number of patients lost to follow-up;

²United States, Netherlands, Germany, Italy, and Chile;

³Use of accessory devices was not a predictor of clinical success;

⁴Clinical success rate. SS: Simple suction; TG: Twin Grasper; AC: Anchor.