Clinical Study on Continuous Suture of Endoscopic Mucosal Defects

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

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.

Study Overview

• Status: Completed
• Conditions: Gastrointestinal Neoplasms; Colonic Polyp
• Intervention / Treatment: Device: Cotinuous suture; Device: Clips

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.

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100039
      • The Fifth Medical Center of Chinese PLA General Hosptial

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Affiliated Hospital to Academy of Military Medical Sciences
• Investigators: Principal Investigator: Yan Liu, MD, Beijing 302 Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 18, 2022
• Primary Completion (Actual): June 30, 2022
• Study Completion (Actual): July 30, 2022

Study Registration Dates

• First Submitted: November 23, 2021
• First Submitted That Met QC Criteria: December 28, 2021
• First Posted (Actual): January 13, 2022

Study Record Updates

• Last Update Posted (Actual): April 2, 2024
• Last Update Submitted That Met QC Criteria: March 30, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Endoscopic submucosal dissection; Endoscopic mucosal resection; Continuous suture; Clips; Gastrolintestinal polyps
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Diseases; Pathological Conditions, Anatomical; Polyps; Intestinal Polyps; Gastrointestinal Neoplasms; Digestive System Neoplasms; Colonic Polyps
• Other Study ID Numbers: 307-GIE-Suture

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No