Clinical Study on Continuous Suture of Endoscopic Mucosal Defects

Affiliated Hospital to Academy of Military Medical Sciences

Status: Completed

Conditions: Colonic Polyp; Gastrointestinal Neoplasms

Treatments: Device: Cotinuous suture; Device: Clips

Study type: Interventional

Funder types: Other

Identifiers

NCT05190042

307-GIE-Suture

Details and patient eligibility

About

The use of clips to completely clip mucosal defects after ESD/EMR can reduce postoperative adverse events, but the rate of incomplete mucosal defects closure is high. The continuous suture technique can completely close the mucosal defects by using surgical sutures and clips to suture the mucosal defects after ESD/EMR. In this study, a clinical randomized controlled study was conducted in our hospital. A total of 62 enrolled patients were divided into two groups, 31 patients were set as a treatment group using continuous suture technique to close post-EMR/ESD mucosal/submucosal defects, the rest patients were set as a control group using clips. The safety and effectiveness of continuous sutures and clips to clamp the post-EMR/ESD mucosal/submucosal defect were compared in the two groups. The complete mucosal/submucosa defects closure rates were the primary outcome.

Full description

Endoscopic submucosal resection (EMR) or submucosal dissection (ESD) for gastrointestinal lesions were used to treat early gastrointestinal cancer or large benign polyps, and their complete resection rates were high, which greatly reduce unnecessary surgical operations. However, after endoscopic resection of mucosal/submucosal lesions, large mucosal/submucosal defects may be created. These defects may cause more delayed postoperative adverse events (bleeding, perforation). The use of clips to completely seal the mucosal defect after gastrointestinal mucosal/submucosal lesion resection can significantly reduce postoperative adverse events, but the rate of incomplete mucosal defects closure is high. The surgical sutures combined with clips to close the mucosal defect after surgery significantly increased the complete closure rates of the post-EMR/ESD mucosal/submucosal defect. This study intends to further determine its safety and effectiveness through a clinical randomized controlled study, and standardize indications and contraindications. A total of 62 enrolled patients were allocated into two groups, 31 patients were set as a treatment group using continuous suture technique to close post-EMR/ESD mucosal/submucosal defects, the rest patients were set as a control group using clips. The safety and effectiveness of continuous sutures and clips to clamp the post-EMR/ESD mucosal/submucosal defect were compared in the two groups. The primary outcome was complete mucosal/submucosa defects closure rates. The secondary outcomes were the closure time, closure speed, and immediate bleeding during the operation as well as delayed bleeding, delayed perforation, and polyps syndrome after resection.

Enrollment: 62 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. The indications for endoscopic resection were large (≥20mm in diameter), nonpedunculated, benign, and early malignant mucosal or submucosal gastric or colorectal lesions.
2. Written informed consent

Exclusion criteria

1. The tumor has spread to the muscularis layer, lymph nodes, or distal metastases;
2. Multiple lesions (≥20mm in diameter) ;
3. Underlying bleeding disorder;
4. The platelet count less than 50×10^9/L;
5. Serious cardio-pulmonary, hepatic or renal disease;
6. Intolerance to endoscopy;
7. Other high-risk conditions or disease (such as massive ascites, etc.);
8. Pregnancy.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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62 participants in 2 patient groups

Continuous suture group

Experimental group

Description:

Surgical sutures were used to completely close the post-EMR/ESD mucosal/submucosal defects. This group was set as a experimental group.

Treatment:

Device: Cotinuous suture

Clips group

Active Comparator group

Description:

Clips were used to completely close the post-EMR/ESD mucosal/submucosal defects. This group was set as a control group.

Treatment:

Device: Clips