Clinical Study on Continuous Suture of Endoscopic Mucosal Defects

Gastrointestinal Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05190042
• Other study ID #: 307-GIE-Suture
• Status: Completed
• Phase: N/A
• Start date: January 18, 2022
• Est. completion date: July 30, 2022

Study information

• Verified date: March 2024
• Source: Affiliated Hospital to Academy of Military Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: July 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Colonic Polyp
• Colonic Polyps
• Digestive System Neoplasms
• Gastrointestinal Neoplasms

Intervention

Device:
• Cotinuous suture
Cotinuous suture using surgery thread
• Clips
Hemostatic clips

Locations

Country	Name	City	State
China	The Fifth Medical Center of Chinese PLA General Hosptial	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Affiliated Hospital to Academy of Military Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Post polypectomy syndrome	Post polypectomy syndrome was defined by symptoms of pain, fever, leukocytosis, peritoneal tenderness, and guarding.	14 days