Clinical Study on Continuous Suture of Endoscopic Mucosal Defects

NCT ID: NCT05190042

Last Updated: 2024-04-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-18
• Study Completion Date: 2022-07-30

Brief Summary

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.

Detailed 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.

Conditions

Colonic Polyp; Gastrointestinal Neoplasms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Continuous suture group

Surgical sutures were used to completely close the post-EMR/ESD mucosal/submucosal defects.

This group was set as a experimental group.

Group Type: EXPERIMENTAL

Cotinuous suture

Intervention Type: DEVICE

Cotinuous suture using surgery thread

Clips group

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

Group Type: ACTIVE_COMPARATOR

Clips

Intervention Type: DEVICE

Hemostatic clips

Interventions

Cotinuous suture

Cotinuous suture using surgery thread

Intervention Type: DEVICE

Clips

Hemostatic clips

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Affiliated Hospital to Academy of Military Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yan Liu, MD

Role: PRINCIPAL_INVESTIGATOR

Beijing 302 Hospital

Locations

The Fifth Medical Center of Chinese PLA General Hosptial

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

307-GIE-Suture

Identifier Type: -

Identifier Source: org_study_id