Clinical Study on Continuous Suture of Endoscopic Mucosal Defects

Study Overview
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Brief Summary
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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
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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.

Official Title
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Clinical Study on Continuous Suture of Mucosal Defects After Endoscopic Mucosal Lesion Resection

Conditions
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Colonic Polyp, Gastrointestinal Neoplasms

Intervention / Treatment
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* Device: Cotinuous suture
* Device: Clips


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The indications for endoscopic resection were large (≥20mm in diameter), nonpedunculated, benign, and early malignant mucosal or submucosal gastric or colorectal lesions. Written informed consent Exclusion Criteria: The tumor has spread to the muscularis layer, lymph nodes, or distal metastases; Multiple lesions (≥20mm in diameter) ; Underlying bleeding disorder; The platelet count less than 50×10^9/L; Serious cardio-pulmonary, hepatic or renal disease; Intolerance to endoscopy; Other high-risk conditions or disease (such as massive ascites, etc.); Pregnancy.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Continuous suture group<br>Surgical sutures were used to completely close the post-EMR/ESD mucosal/submucosal defects. This group was set as a experimental group. | Device: Cotinuous suture<br>* Cotinuous suture using surgery thread<br>|
| Active Comparator: Clips group<br>Clips were used to completely close the post-EMR/ESD mucosal/submucosal defects. This group was set as a control group. | Device: Clips<br>* Hemostatic clips<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rates of complete closure of mucosal/submucosal defects | When the clips were applied next to each other and there were no substantial submucosal areas in the closure line | 1day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The duration time of closure | The duration of closure was defined as the interval from insertion of the first clip until complete or incomplete closure | 1 day | 
| The closure speed | The closure speed was defined as the resection area divided by 10x the duration of the ligation procedure (cm2 /10 minutes). | 1day | 
| Immediate bleeding | Immediate bleeding refers to those episodes of hemorrhage that occurred during the procedure and lasted more than 30 seconds or required endoscopic treatment. | 1 day | 
| Delayed bleeding | Delayed bleeding was defined as bleeding requiring emergency endoscopic hemostasis or transfusion or the presence of hemoglobin loss≥2 g/dL after EMR/ESD | 14 days | 
| Delayed perforation | Delayed perforation was defined as the presence of free air on abdominal CT or radiography after completion of the procedure in patients without perforation during EMR/ESD and no symptoms of peritoneal irritation after EMR/ESD | 14 days | 
| Post polypectomy syndrome | Post polypectomy syndrome was defined by symptoms of pain, fever, leukocytosis, peritoneal tenderness, and guarding. | 14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endoscopic mucosal resection, Endoscopic submucosal dissection, Gastrolintestinal polyps, Continuous suture, Clips