The efficacy of two kinds of scissor-type knives for colorectal endoscopic submucosal dissection: A retrospective comparative study

doi:10.21203/rs.3.rs-4332186/v1

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Research Article

The efficacy of two kinds of scissor-type knives for colorectal endoscopic submucosal dissection: A retrospective comparative study

https://doi.org/10.21203/rs.3.rs-4332186/v1

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Introduction:

Scissor-type knives are spreading as safe devises in endoscopic submucosal dissection (ESD). We evaluated the efficacy of two kinds of scissor-type knives (Clutch Cutter: CC, Fujifilm and SB knife Jr2: SB, SB-Kawasumi) in colorectal ESD.

Methods

This single-center retrospective study analyzed 178 ESD cases treated with CC from January 2020 to August 2021 and 91 cases with SB from September 2021 to December 2023. The two groups were compared through propensity score matching. Therapeutic results, such as ESD procedure time, en bloc resection rate, perioperative bleeding frequency, and complications, were analyzed in each group. Risk factors for long ESD procedure time (≥ 90 min) were also examined.

Results

After matching, 87 cases in each group were analyzed. There was no significant difference in the ESD procedure time (min, median [interquartile range]) between the CC and SB groups (54 [36–72] vs. 53 [39–72], p = 0.99). Additionally, there were no differences in the en bloc resection (100% vs. 100%, p = 1.00), perioperative perforation (1.1% vs. 1.1%, p = 1.00), or delayed bleeding (1.1% vs. 0.0%, p = 1.00). There was a significant difference in perioperative bleeding frequency (mean ± standard deviation: 1.8 ± 2.6 vs. 3.0 ± 3.5, p < 0.01). The significant risk factors (odds ratio [95% confidence interval]) for long ESD procedure time in patients treated with CC or SB were antiplatelet (7.51 [1.82-31.00]), large lesion size (1.08 [1.05–1.12]), severe fibrosis (24.30 [7.60–77.90]), and perioperative bleeding frequency (1.34 [1.14–1.56]).

Conclusions

CC and SB in colorectal ESD enabled high en bloc resection and low complication rates. CC showed significantly less perioperative bleeding than SB.

Colorectal tumors

Scissor-type knife

Clutch cutter

SB knife

Endoscopic submucosal dissection

Colorectal cancer ranks third in incidence and second in mortality worldwide [1]. Because of its high incidence and mortality rates, colorectal cancer poses a public health concern. Due to improvements in colonoscopy and the widespread use of colonoscopy, the number of endoscopic treatments for early colorectal lesions is increasing. Currently, endoscopic submucosal dissection (ESD) is a treatment for resecting large colorectal lesions en bloc and is becoming a common treatment for early large colorectal lesions worldwide [2, 3]. However, colorectal ESD is more difficult to perform than gastric ESD due to the winding nature, thin wall, and poor operability of the colon. A previous multicenter study in Japan (1965 patients from 2013 to 2015) reported rates of perioperative perforation, delayed perforation, massive perioperative hemorrhage, and delayed bleeding of 2.6%, 0.6%, 0.7%, and 2.2%, respectively [4]. Therefore, many techniques and devices, such as traction devices and pocket-creation method, have been reported to facilitate the colorectal ESD in a safe and effective manner [5, 6].

Various ESD knives have been developed for the treatment of early colorectal lesions [7–10]. These include needle-type knives such as the Dual Knife (Olympus Co., Tokyo, Japan) and the Flush Knife BT-S (Fujifilm Medical Co., Tokyo, Japan) and blade-type knives such as the IT Knife (Olympus Co., Tokyo, Japan). More recently, ProKnife (Boston Scientific, MA, USA), which has a strong injection function as a needle-type knife, was released [8]. In addition, there are two scissor-type knives, SB Knife Jr2 (SB; SB-Kawasumi Inc., Kanagawa, Japan) and Clutch Cutter (CC; Fujifilm, Tokyo, Japan), in the world [10]. The scissor-type knives can perform all steps of the ESD procedure, including mucosal incision, submucosal dissection, and hemostasis. Compared with other types of knives, scissor-type knives are much less likely to perforate due to unintentional movement [10, 11]. Recently, the use of scissor-type knives has been implemented not only for colorectal ESD but also for esophageal and duodenal ESD due to its safety [12, 13]. However, no studies have compared the efficacy and safety of the two scissor-type knives for colorectal ESD. In the present study, we conducted a retrospective analysis to evaluate the efficacy and safety of colorectal ESD with CC compared to those of colorectal ESD with SB.

This was a single-center retrospective comparative study. We reviewed 269 patients who underwent colorectal ESD at our center between January 2020 and December 2023. Among them, 178 patients treated with CC from January 2020 to August 2021 and 91 patients treated with SB from September 2021 to December 2023 were compared. In accordance with the Japanese Society of Gastroenterological Endoscopy Guidelines for ESD/endoscopic mucosal resection (EMR), the indication for colorectal ESD was lesions ≥ 20 mm in size that were difficult to manage with en bloc resection via EMR [14]. Among patients < 20 mm in size, those with severe fibrosis due to biopsy, recurrence after endoscopic treatment, and neuroendocrine tumors were included. Endoscopic diagnosis of the lesion was performed by narrow band imaging (NBI), blue laser imaging (BLI), and pit pattern observation in all patients. The primary outcome of this study was the median number of ESD procedures performed in the CC and SB groups. To minimize the bias of patients and lesion characteristics in the CC and SB groups, we performed propensity score matching for age, sex, and factors with p values < 0.2, such as tumor location, fibrosis state and PCM, as background factors (Fig. 1). The secondary outcomes were other therapeutic results, such as en bloc resection, complete resection, perioperative bleeding frequency, complications, and histopathological diagnosis and in each group. Complications included perioperative perforation, massive perioperative bleeding, delayed perforation, and delayed bleeding. We also analyzed the median number of ESD procedures performed in each group under various conditions, such as lesion locations, morphologies, tumor sizes, fibrosis states and endoscopist experience. In addition, we examined the risk factors associated with a long ESD procedure time (≥ 90 min) in all patients in the CC and SB groups, using univariate and multivariate analyses. Multivariate analysis was performed for only significant factors in univariate analysis with p values < 0.05.

The tumor location was classified as right-sided (from the cecum to the transverse colon) or left-sided (from the descending colon to the rectum). The tumor morphology was classified as polypoid or nonpolypoid according to the Paris classification [15]. Fibrosis was classified as the presence or absence of severe fibrosis. The total number of endoscopists was 20, and experts were defined as those who had performed more than 5000 colonoscopies and 200 colorectal ESDs, resulting in the inclusion of 2 experts and 18 nonexperts. Perioperative perforation was defined as a hole in the muscle layer detected by endoscopy during the ESD procedure and free air detected by abdominal computed tomography after ESD. Massive perioperative bleeding was defined as bleeding during ESD which was not stopped with CC or SB and stopped with hemostatic forceps. Delayed perforation was defined as the detection of free air by abdominal computed tomography after ESD which was not related with perioperative perforation. Delayed bleeding was defined as the development of bleeding with either endoscopic hemostasis or > 2 g/dL decrease in the hemoglobin level.

Histopathological diagnosis was based on the World Health Organization (WHO) classification [16]. Complete resection was defined as both horizontal and vertical negative margins. High-grade adenoma and intramucosal carcinoma were treated as high-grade dysplasia. This research was conducted with the approval of the Ethics Committee of Kyoto Prefectural University of Medicine (ERB-C-1600) and in accordance with the World Medical Association Declaration of Helsinki.

Structure of CC and SB

The CC and SB were scissor-type knives (Fig. 1). The lengths of the CC and SB were both 3.5 mm (Fig. 2). The width of the CC was 0.4 mm. The height of the SB was 0.3 mm at the front and 0.2 mm at the back. The shapes of the SB and CC were different. The CC had serrated shapes, and the SB had prongs at the tip and in the middle. Thus, the cross-sectional area of CC was greater than that of SB.

Pretreatment and equipment for ESD

The patients were given a low-residue diet the day before ESD and 10 mL of sodium picosulfate hydrate at 9 PM. On the morning of the ESD day, the patients were administered 1.0 L of high-density polyethylene glycol solution containing ascorbic acid (MoviPrep; Ajinomoto Pharmaceutical Co., Tokyo, Japan) or 0.5 L of oral sulfate solution (SULPREP; Fuji Pharma Co., Ltd., Tokyo, Japan) [17, 18]. In all colorectal ESD cases, either EC-L600ZP (Fujifilm Medical Co., Tokyo, Japan) or EC-L600ZP7 (Fujifilm, Tokyo, Japan) with a water supply system and carbon dioxide insufflation (GW-100: Fujifilm, Tokyo, Japan) were used. Two kinds of transparent hoods (Elastic Touch, F-25: Top Co., Tokyo, Japan or short ST hood, DH-29CR: Fujifilm Medical Co., Tokyo, Japan) were attached to the end of the endoscope according to the degree of fibrosis. A lens cleaner (Cleash: Fujifilm, Tokyo, Japan) was used for the lens and water/air device to prevent fogging and dirt of the endoscopic lens. During ESD, sedation was administered using midazolam (Dormicum; Astellas Pharmaceuticals Co., Tokyo, Japan) or propofol (Propofol Nichi-Iko Pharmaceutical Co., Ltd., Toyama, Japan), and analgesia was provided with pentazocine (Pentazin; Sankyo Pharmaceuticals Co., Tokyo, Japan). A local injection solution in which a small amount of 0.2% indigo carmine (final concentration: 0.06% indigo carmine) was added to a solution of 0.2% or 0.4% sodium hyaluronate (MucoUp; Boston Scientific Japan Co., Tokyo, Japan). The injection was performed using a 25-G high-flow-type puncture needle for the endoscope (ImpactFlow; TOP Corporation, Tokyo, Japan). The high-frequency electronic devices used were a VIO300D and VIO3 (Erbe Elektromedizin Co., Tubingen, Germany). Regarding the setting of it, CC and SB were used for marking (forced coagulation, 6.0), mucosal incision (Endocut I, Effect 1, Duration 4, Interval 1), submucosal dissection (Swift coagulation, 3.8 and Endocut I), and hemostasis (Major: Soft coagulation, 3.0; Minor: Swift coagulation, 3.8) in all patients. For tumors ≥ 50 mm in size, a Flush Knife BT-S 2.0 mm (Fujifilm, Tokyo, Japan) or Proknife (Boston Scientific, MA, USA) was used only for the mucosal incision. The traction devices used were S-O clips (Zeon Medical, Tokyo, Japan) or SureClip Traction Bands (MicroTech, Nanjing, China). For clip closure of ESD ulcer, SureClip and Mantis Closure device (Boston Sci. MA, USA) were used.

ESD procedure with CC and SB (Fig. 3)

ESD was performed according to previous methods [9]. After injecting hyaluronic acid (MucoUp, Boston Scientific Japan, Tokyo, Japan) into the submucosal area of the lesion, a full-circumference mucosal incision was made using CC or SB with Endocut I mode and SB, followed by trimming of the incision line with SWIFT coagulation mode. After that, we regularly deployed the traction device to the anal side of the lesion to achieve good traction. Then, we dissected the submucosal layer of the lesion using CC or SB (SWIFT coagulation and Endocut I mode). In cases of perioperative bleeding, we primarily used CC or SB (Soft coagulation) to manage bleeding. Finally, en bloc resection of the lesion was achieved. Suturing with endoscopic clips was performed for patients at risk of delayed bleeding and perforation according to each endoscopist’s decision.

Statistical analyses

T tests and chi-square tests were used. We performed propensity score matching using a logistic regression model with the following covariates: age, sex, tumor size, severe fibrosis, and endoscopist experience level. Furthermore, the absolute standardized difference (ASD) value was examined to assess the validity of the matching, and an ASD value of ≤ 0.2 was considered appropriate. P values < 0.05 were considered to indicate statistical significance. Multivariate logistic regression analysis was performed to determine the risk factors for a procedure time ≥ 90 min in all patients and in the CC and SB groups. Specifically, only factors showing p < 0.1 in the univariate analysis were examined. The statistical analyses were performed using the SPSS software program (version 24.0 for Windows; IBM Japan, Ltd., Tokyo, Japan).

After propensity score matching, 87 patients in the CC and SB groups were analyzed (Fig. 1). There were no significant differences in tumor location (right side) (51.7% vs. 52.9%, p = 0.88), tumor morphology type (polypoid type) (20.7% vs. 12.6%, p = 0.15), tumor size (28.6 ± 22.1 vs. 28.3 ± 15.8 mm, p = 0.92), severe fibrosis (5.7% vs. 5.7%, p = 1.00), endoscopist experience (expert) (32.2% vs. 36.8%, p = 0.52), or use of PCM (37.9% vs. 39.1%, p = 0.88) between the CC and SB groups (Table 1).

Table 1

Comparison of the background characteristics of the CC and SB groups before and after propensity score matching
	Before matching		ASD	p value	After matching		ASD	p value
	CC (n = 178)	SB (n = 91)			CC (n = 87)	SB (n = 87)
Age, mean ± SD	69.7 ± 11.0	68.8 ± 10.6	0.08	0.54	69.1 ± 11.4	69.4 ± 10.3	0.03	0.85
Sex, male/female, n (%)	82/96 (46.1/53.9)	47/44 (51.6/48.4)	0.11	0.39	41/46 (47.1/52.9)	45/42 (51.7/48.3)	0.09	0.54
Antiplatelet, n (%)	22 (12.4)	6 (6.6)	0.20	0.14	10 (11.5)	6 (6.9)	0.15	0.29
Anticoagulant, n (%)	15 (8.4)	6 (6.6)	0.08	0.59	5 (5.7)	6 (6.9)	0.03	1.00
Tumor location, Right-side/Left-side, n (%)	109/69 (61.2/38.8)	46/45 (50.5/49.5)	0.21	0.09	45/42 (51.7/48.3)	46/41 (52.9/47.1)	0.02	0.88
Morphology, polypoid/nonpolypoid, n (%)	34/144 (19.1/80.9)	13/78 (14.3/85.7)	0.13	0.33	18/69 (20.7/79.3)	11/76 (12.6/87.4)	0.22	0.15
Tumor size, mm, mean ± SD (range)	28.9 ± 18.7 (3-200)	28.7 ± 17.4 (3-100)	0.01	0.94	28.6 ± 22.1 (3-200)	28.3 ± 15.8 (3–86)	0.02	0.92
Tumor size < 40 mm, n (%)	148 (83.1)	75 (82.4)	0.17	0.21	69 (79.3)	72 (82.8)	0.03	0.86
Tumor size ≥ 40 mm, n (%)	30 (16.9)	16 (17.6)	0.16	0.64	18 (20.7)	15 (17.2)	0.11	0.76
Severe fibrosis, n (%)	33 (18.5)	5 (5.5)	0.41	< 0.01	5 (5.7)	5 (5.7)	0.00	1.00
Endoscopist, expert/nonexpert, n (%)	62/116 (34.8/65.2)	34/57 (37.4/62.6)	0.05	0.68	28/59 (32.2/67.8)	32/55 (36.8/63.2)	0.10	0.52
PCM, n (%)	82 (46.1)	34 (37.4)	0.18	0.17	33 (37.9)	34 (39.1)	0.02	0.88
Use of traction device, n (%)	140 (78.7)	73 (80.2)	0.04	0.76	68 (78.2)	69 (79.3)	0.03	0.85
CC: clutch cutter, SB: SB knife, PCM: pocket-creation method, ASD: absolute standardized difference, SD: standard deviation, Right-side: cecum to transverse colon, Left-side: descending colon to rectum.

In terms of the therapeutic outcomes of the CC and SB groups, there were also no significant differences in the rates of en bloc resection (100.0% vs. 100.0%, p = 1.00) or complete resection (92.0% vs. 95.4%, p = 0.35). There was a significant difference in perioperative bleeding frequency (mean ± standard deviation (SD)) (1.8 ± 2.6 vs. 3.0 ± 3.5, p < 0.01). There were no significant differences in the incidence of perioperative perforation (1.1% vs. 1.1%, p = 1.00), delayed perforation (0.0% vs. 1.1%, p = 1.00), or delayed bleeding (1.1% vs. 0.0%, p = 1.00) between the CC and SB groups (Table 2).

Table 2

Comparison of the therapeutic outcomes of the CC and SB groups in colorectal ESD
	CC (n = 87)	SB (n = 87)	P value
ESD procedure time, min, median (IQR)	54.0 (36.0–72.0)	53.0 (39.0–72.0)	0.99
En bloc resection, n (%)	87 (100.0)	87 (100.0)	1.00
Complete resection, n (%)	80 (92.0)	83 (95.4)	0.35
Perioperative bleeding frequency, mean ± SD	1.8 ± 2.6	3.0 ± 3.5	< 0.01
Complications
Perioperative perforation, n (%)	1 (1.1)	1 (1.1)	1.00
Massive perioperative bleeding n (%)	0 (0.0)	1 (1.1)	1.00
Delayed perforation, n (%)	0 (0.0)	1 (1.1)	1.00
Delayed bleeding, n (%)	1 (1.1)	0 (0.0)	1.00
Histopathological diagnosis			0.90
SSL, n (%)	6 (6.9)	9 (10.3)
LGA, HGD, n (%)	45 (51.7)	45 (51.7)
T1, n (%)	29 (33.3)	27 (31.0)
NET, n (%)	6 (6.9)	4 (4.6)
Others, n (%)	1 (1.1)	2 (2.3)
ESD: endoscopic submucosal dissection, CC: clutch cutter, SB: SB knife, SSL: sessile serrated lesion, LGA: low-grade adenoma, HGD: high-grade dysplasia, T1: T1 cancer, NET: neuroendocrine tumor, SD: standard deviation, IQR: interquartile range.

In terms of the ESD procedure duration (min, median [interquartile range]) for all patients, there was no significant difference between the CC and SB groups (54 [36–72] vs. 53 [39–72], p = 0.99) (Table 3). In addition, there were no significant differences in the ESD procedure time between the two groups based on tumor size (tumor size < 40 mm: 46 [32–61] vs. 48 [35.3–63], p = 0.34; tumor size ≥ 40 mm: 93 [67.8-121.8] vs. 83 [63–122], p = 0.89); fibrosis (severe fibrosis: 72 [43-105.5] vs. 99 [80–130], p = 0.17; nonsevere fibrosis: 53.3 [35.8–68.3] vs. 50.5 [38.5–70], p = 0.79).

Table 3

Colorectal endoscopic submucosal dissection procedure time under various conditions in the CC and SB groups
ESD procedure time, min, median (IQR)	CC	SB	P value
All cases	54.0 (36.0–72.0)	53.0 (39.0–72.0)	0.99
Right-side	53.0 (37.0-68.5)	49.5 (33.0-72.8)	0.57
Left-side	54.5 (34.5–76.5)	54.0 (42.0–73.0)	0.44
Polypoid	44.5 (27.0-66.8)	46.0 (25.0–71.0)	0.95
Nonpolypoid	54.0 (37.8–73.0)	54.0 (41.5–73.5)	0.85
Tumor size < 40 mm	46.0 (32.0–61.0)	48.0 (35.3–63.0)	0.34
Tumor size ≥ 40 mm	93.0 (67.8-121.8)	83.0 (63.0-122.0)	0.89
Severe fibrosis	72.0 (43.0-105.5)	99.0 (80.0-130.0)	0.17
No severe fibrosis	53.3 (35.8–68.3)	50.5 (38.5–70.0)	0.79
Expert	44.0 (26.5–89.5)	36.0 (26.5–81.0)	0.48
Nonexpert	54.0 (42.0–65.0)	55.0 (48.0–70.0)	0.16
CC: clutch cutter, SB: SB knife, Right-side: cecum to transverse colon, Left-side: descending colon to rectum, IQR: interquartile range.

Multivariate analysis revealed significant risk factors for an ESD procedure time ≥ 90 min (odds ratio, 95% confidence interval) in all patients in the CC and SB groups before propensity score matching: antiplatelet therapy (7.51 [1.82-31.00], p < 0.01), large lesion size (1.08 [1.05–1.12], p < 0.01), severe fibrosis (24.30 [7.60–77.90], p < 0.01), and perioperative bleeding frequency (1.34 [1.14–1.56], p < 0.01) (Table 4).

Table 4

A comparison of all patients with an ESD procedure time ≥ 90 and < 90 min before propensity score matching
	All 269 cases before matching		p value	Multivariate analysis		p value
	Procedure time < 90 min (n = 232)	Procedure time ≥ 90 min (n = 37)		OR	95% CI
Age, mean ± SD	68.9 ± 10.7	72.1 ± 12.0	0.11
Sex, male/female, n (%)	116/116 (50.0/50.0)	13/24 (35.1/64.9)	0.09
Antiplatelet, n (%)	20 (8.6)	8 (21.6)	0.01	7.51	1.82-31.00	< 0.01
Anticoagulant, n (%)	16 (6.9)	5 (13.5)	0.16
Tumor location, Right-side/Left-side, n (%)	130/102 (56.0/44.0)	25/12 (67.6/32.4)	0.19
Morphology, polypoid/nonpolypoid, n (%)	40/192 (17.2/82.8)	7/30 (18.9/81.1)	0.80
Tumor size, mm, mean ± SD	25.5 ± 11.2	49.2 ± 34.4	< 0.01	1.08	1.05–1.12	< 0.01
Tumor size, < 40 mm/≥40 mm, n (%)	208/24 (89.7/10.3)	15/22 (40.5/59.5)	< 0.01
Severe fibrosis, n (%)	18 (7.8)	20 (54.1)	< 0.01	24.30	7.60–77.90	< 0.01
Endoscopist, expert/nonexpert, n (%)	71/161 (30.6/69.4)	25/12 (67.6/32.4)	< 0.01	2.09	0.72–6.02	0.17
Types of knives, CC/SB, n (%)	151/81 (65.1/34.9)	27/10 (73.0/27.0)	0.35
ESD procedure time, min, median (IQR)	50.0 (37.0–63.0)	120.0 (104.5–142.0)	< 0.01	n.c.
En bloc resection, n (%)	231 (99.6)	36 (97.3)	0.26
Complete resection, n (%)	217 (93.5)	32 (86.5)	0.13
Perioperative bleeding frequency, mean ± SD	1.7 ± 2.2	5.2 ± 5.1	< 0.01	1.34	1.14–1.56	< 0.01
Complications
Perioperative perforation, n (%)	1 (0.4)	2 (5.4)	0.06
Massive perioperative bleeding, n (%)	1 (0.4)	0 (0.0)	1.0
Delayed perforation, n (%)	0 (0.0)	3 (8.1)	< 0.01	n.c.
Delayed bleeding, n (%)	2 (0.9)	0 (0.0)	1.00
Histopathological diagnosis			0.36
SSL, n (%)	23 (9.9)	2 (5.4)
LGA, HGD, n (%)	121 (52.2)	18 (48.6)
T1, n (%)	73 (31.5)	17 (45.9)
NET, n (%)	12 (5.2)	0 (0.0)
Others, n (%)	3 (1.3)	0 (0.0)
ESD: endoscopic submucosal dissection, CC: clutch cutter, SB: SB knife, SSL: sessile serrated lesion, LGA: low-grade adenoma, HGD: high-grade dysplasia, T1: T1 cancer, NET: neuroendocrine tumor, Right-side: cecum to transverse colon, Left-side: descending colon to rectum, SD: standard deviation, IQR: interquartile range, OR: odds ratio, CI: confidence interval, n.c.: not calculated.

In addition, we reviewed the data of 9 patients who experienced ESD complications due to the use of a CC or SB knife among the remaining 269 patients (Table 5). Three patients experienced perioperative perforation, one experienced massive perioperative hemorrhage, two experienced delayed bleeding, and three experienced delayed perforation.

Table 5

Patients with complications in the CC and SB groups who underwent ESD before propensity score matching
Case	Knife	Age	Sex	AP/ AC	Lo	Mo	Size (mm)	SF	End	PT (min)	En	Complications	His
1	CC	71	M	+/-	A	P	20	-	E	115	+	Perioperative perforation	HGD
2	CC	68	M	-/-	A	NP	20	+	Et	84	+	Perioperative perforation	LGA
3	CC	74	M	-/+	T	NP	30	-	NE	60	+	Delayed bleeding	HGD
4	CC	75	M	+/-	A	NP	30	+	E	60	+	Delayed bleeding	HGD
5	CC	68	F	-/-	S	P	100	+	E	197	+	Delayed perforation	T1
6	SB	73	F	-/-	T	NP	50	+	E	99	+	Perioperative perforation	SSL
7	SB	75	M	+--	C	P	50	+	E	122	+	Delayed perforation	T1
8	SB	79	M	-/-	R	NP	20	-	NE	72	+	Massive perioperative bleeding	HGD
9	SB	81	F	+/-	R	NP	80	-	E	277	+	Delayed perforation	HGD
CC: Clutch Cutter, SB: SB knife, M: male, F: female, AP: antiplatelet, AC: anticoagulant, Lo: location, C: cecum, A: ascending colon, T: transverse colon, S: sigmoid colon, R: rectum, Mo: morphology, P: polypoid, NP: nonpolypoid, SF: severe fibrosis, Endo: Endoscopists, E: expert, NE: nonexpert, PT: procedure time, En: en bloc resection, His: histopathological diagnosis, SSL: sessile serrated lesion, LGA: low-grade adenoma, HGD: high-grade dysplasia, T1 cancer

In the current study, using propensity score matching, the use of scissor-type knives with either CC or SB was associated with higher rates of en bloc resection (100%/100%), complete resection (92.0%/95.4%), and acceptable ESD procedure time (54.0/53.0 min) in colorectal ESD, while lower rates of complications such as perioperative/delayed perforation and bleeding were observed. Additionally, there were no significant differences in ESD procedure time, location, morphology, size, fibrosis status, or endoscopist experience. However, the perioperative bleeding frequency was lower in the CC group than in the SB group (mean ± SD: 1.8 ± 2.6 vs. 3.0 ± 3.5, p < 0.01). We also found that the risk factors for an ESD procedure time ≥ 90 min were tumor size, severe fibrosis, perioperative bleeding frequency and antiplatelet therapy. To the best of our knowledge, this is the first paper to show the detailed differences between two scissor-type knives.

CC was first reported as a ESD knife in 2007 [19]. Previous studies have shown its efficacy not only for esophageal, gastric, duodenal, and colorectal ESD but also for the treatment of Zenker diverticulum in Japan and Western countries [10, 12, 13, 20]. CC can effectively control perioperative bleeding, and it is associated with fewer severe bleeding events requiring hemostatic forceps [10]. We previously reported that CC with PCM and a traction device enabled a shorter ESD procedure time than CC with PCM [21]. In the present study, CC did not show any massive perioperative bleeding and did not require the use of hemostatic forceps for colorectal ESD. The rates of perioperative perforation, delayed perforation, and delayed bleeding were 1.1%, 0.0%, and 1.1%, respectively. On the other hand, initial SB knives with a long blade were first reported in 2010, after which various types of SB knives were developed [22]. In a multicenter study, colorectal ESD of 102 colorectal lesions was performed using an SB knife Jr [23]. The results showed that all tumors were resected en bloc, the mean procedure time was less than 1 hour, and the mean tumor size was greater than 40 mm. Other studies on colorectal ESD reported a lower rate of complications such as severe hemorrhage compared to that for colorectal ESD using other types of knives [24, 25]. Our study also revealed lower rates of perioperative perforation, massive perioperative bleeding, delayed perforation and bleeding. There were no significant differences in most of the therapeutic results between the CC and SB groups. However, we showed that patients treated with CC had less perioperative bleeding than did patients treated with SB in the current study. We suggest that this was probably because the CC has a thick serrated knife, whereas the SB has a straight and thin knife. Therefore, it is difficult to control severe perioperative bleeding in patients treated with SB [10]. However, SB, with its thin knife, enables a sharp mucosal incision compared to that of CC, although the data were not obtained in the present study. Additionally, the rotation function of an assistant is also different between the two knives. We must be aware of these differences between SB and CC for clinical use.

Needle-type knives are commonly used in ESD procedures worldwide [26]. To compare the efficacy and safety of the needle-type knife and SB, a total of 2330 patients (2498 lesions) who underwent colorectal ESD, including procedures using needle-type (1923 patients, 2067 lesions) and scissor-type (407 patients, 431 lesions) knives, were analyzed in a multicenter study [11]. The results showed that the median resection speed was faster in the needle-type group (18.3 mm²/min) than in the scissor-type group (13.2 mm²/min, p < 0.0001), whereas the en bloc and complete resection rates were not different between the two groups. The rates of intraoperative perforation and delayed bleeding were significantly lower with the scissor-type knife than with the needle-type knife (intraoperative perforation: 0.7% vs. 2.5%, p = 0.0431; delayed bleeding: 0.7% vs. 2.5%, p = 0.0431). In another randomized controlled trial (RCT), the self-completion rate for colorectal ESD using the Dual knife as a needle type knife was lower than that in the CC group (87% [39/45] vs. 98% [42/43]) [27]. The ESD procedure time was significantly shorter in the DualKnife group than in the CC group (mean: 62.0 vs. 81.1 mins, p = 0.0036). The intraoperative complication rate (2% vs. 0%) and en bloc resection rate (98% vs. 100%) were not significantly different between the two groups. Our previous colorectal ESD study revealed no significant differences in the en bloc resection rate, complete resection rate, procedure time, or adverse events (perioperative perforation, delayed bleeding, and delayed perforation) between CC and needily type knives [28]. However, among nonexperts, the mean ESD procedure time was shorter for CC than for needle-type knives (mean: 52 vs. 67 mins, p = 0038). Additionally, the semi-self completion rate of nonexperts was significantly greater for CC than for needle-type knives (53.8% vs. 7.4%, p < 0.001). The current study also revealed lower rates of complications for both CC and SB. The procedure times for both knives were not long but were acceptable (54.0 and 53.0 mins). In particular, those of the nonexperts were 54.0 mins and 55.0 mins, although these times were longer than those of the experts. These results suggested that the CC and SB were safe devices and seemed useful, especially for nonexpert patients, in colorectal ESD. However, further prospective studies should be performed to clarify this issue.

An RCT comparing the scissor-type knife to other types of knives, including the IT knife and CC, revealed no difference in the self-completion rate by nonexperts, the en bloc resection rate, or adverse events in gastric ESD [29]. The median procedure time (mins, median, IQR) of the IT knife group (47 [33–67], p = 0.003) was shorter than that of the CC group (66 [40–100]). However, another study of gastric ESD showed that intraoperative bleeding rates were significantly lower in the SB knife group than in the IT knife group (18% vs. 40%; p = 0.01) [30]. Our previous report on gastric ESD showed that CC had a significantly higher completion rate (61.7% vs. 24.5%, p < 0.001) by nonexperts, a shorter ESD procedure time, and fewer bleeding events than the IT knife [31]. Thus, the scissor-type knife procedure is considered safer for nonexperts due to its hemostatic efficacy and low risk of unintentional perforation.

This study had several limitations. This was a retrospective single-center study with a relatively small number of patients. The endoscopists themselves decided which knives were used in ESD. Although propensity score matching analysis was performed to balance patient characteristics, there could be selection bias; for example, the ASD of morphology had a borderline value of 0.22.

In conclusion, both patients treated with CC and those treated with SB underwent colorectal ESD with a high en bloc resection rate, acceptable procedure time, and low complication rate. There was significantly less perioperative bleeding in the CC group than in the SB group. This finding suggested that the functions of dissection of vessels and hemostasis of CC were likely greater than those of SB due to differences in their structure.

Competing Interests

Naohisa Yoshida and Osamu Dohi received the grants for research from Fujifilm Yoshida. Other authors did not have any conflict of interest. No funding was received for this study.

Author Contribution

J.S. and N.Y. organized the study and wrote the main manuscript text. J.S. prepared figures 1-3. R.K. K.I. R.H. O.D. H.K. Y.T. Y.I. arranged the study. All authors reviewed the manuscript.

Acknowledgement

We thank Prof. Zibin Tien in Qingdao University and all members of the Department of Molecular Gastroenterology and Hepatology, Kyoto Prefectural University of Medicine for their help with this study.

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Competing interest reported. Naohisa Yoshida and Osamu Dohi received the grants for research from Fujifilm Yoshida. Other authors did not have any conflict of interest. No funding was received for this study.

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The efficacy of two kinds of scissor-type knives for colorectal endoscopic submucosal dissection: A retrospective comparative study

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Introduction

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Structure of CC and SB

Pretreatment and equipment for ESD

ESD procedure with CC and SB (Fig. 3)

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