Clinical trial NCT05190042: Clinical Study on Continuous Suture of Endoscopic Mucosal Defects
Official title: Clinical Study on Continuous Suture of Mucosal Defects After Endoscopic Mucosal Lesion Resection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colonic Polyp
Gastrointestinal Neoplasms
Keywords: Endoscopic mucosal resection
Endoscopic submucosal dissection
Gastrolintestinal polyps
Continuous suture
Clips
Lead sponsor: Affiliated Hospital to Academy of Military Medical Sciences
Sponsor class: OTHER
First posted: 2022-01-13
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: The rates of complete closure of mucosal/submucosal defects
timeFrame: 1day
Secondary outcomes:
measure: The duration time of closure
timeFrame: 1 day
measure: The closure speed
timeFrame: 1day
measure: Immediate bleeding
timeFrame: 1 day
measure: Delayed bleeding
timeFrame: 14 days
measure: Delayed perforation
timeFrame: 14 days
measure: Post polypectomy syndrome
timeFrame: 14 days
Other outcomes:
Locations:
city: Beijing
country: China
facility: The Fifth Medical Center of Chinese PLA General Hosptial
state: Beijing
Study officials:
affiliation: Beijing 302 Hospital
name: Yan Liu, MD
role: PRINCIPAL_INVESTIGATOR
References: