Purse String Suture Device vs. Endoclip for Immediate Endoscopic Procedure Associated Gastrointestinal Perforation

Not Applicable

• Conditions: Gastrointestinal Perforation; Intervention
• Interventions: Device: Purse string suture device; Device: Endoclips

• Registration Number: NCT03053232
• Lead Sponsor: Affiliated Hospital to Academy of Military Medical Sciences

Brief Summary

Nowadays, endoscopic techniques have been applied for diagnosing and treating a variety of gastrointestinal diseases, such as endoscopic submucosal dissection (ESD) and endoscopic mucosal resection (EMR)technique for removing early gastrointestinal mucosal cancers. Endoscopic procedure associated gastrointestinal perforation is one of the the most severe complications, which is associated with high morality and needs timely detection and effective treatment in clinical practice.Over 90% procedure associated gastrointestinal perforation occurs immediately within 24 h after endoscopic procedure.Endoclips have been widely used in closing the immediate gastrointestinal perforations, but the location of the endoclips could influence the effective rate, limiting its application. In addition, multiple endoclips should be placed under endoscopy for a relatively large perforation, which could increase the medical cost and the procedure time. At recent, a new purse string suture device (LeoMed, China) has been developed by us and introduced to the clinicalmanagement of such patients with procedure associated gastrointestinal perforations. Clinical data validated that the usage of this new purse string suture in treating immediate procedure associated perforations was greatly convenient and effective with very low reoperation rate and postoperative complication rate. A specially designed loop was equipped in this device, which could be tightened under endoscopy. Thus, compared with the placement of endoclips, this device could be more convenient and effective in completely closing the gastrointestinal perforations.This study will test whether purse string suture device will increase the effectiveness of closingimmediate procedure associated gastrointestinal perforationsunder endoscopyin a randomized controlled trialby comparing the use of purse string suture deviceand endoclips.

Detailed Description

This is a randomized controlled trial comparing the use of purse string suture device versus endoclips for closing procedure associated gastrointestinal perforation under endoscopy, which is one of the most severe complications and needs timely treatment. Endoclips have been widely used in closing the gastrointestinal perforations, but the location of the endoclips could significantly influence the effective rate. In addition, multiple endoclips will be needed for a relatively large perforation, which could increase the medical cost and the procedure time. At recent, a new purse string suture device has been developed and introduced to the clinicalmanagement of such patients with gastrointestinal perforations. A loop was equipped in this device, which could be tightened. Thus, compared with endoclips, this device could be more convenient and effective in completely closing the gastrointestinal perforations. This study will test whether purse string suture device will increase the effectiveness of treating procedure associated gastrointestinal perforations under endoscopy in a randomized controlled trial.

Study Timeline

• Status Verified: 2017-02
• Study Start: 2017-02-01
• Study First Submitted: 2017-02-08
• Study First Submitted QC: 2017-02-10
• Last Update Submitted: 2017-02-10
• Study First Posted: 2017-02-15
• Last Update Posted: 2017-02-15
• Primary Completion: 2017-10
• Study Completion: 2018-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Patients ≥18 Years
• Immediate procedure associated gastrointestinal perforation (i.e. post-ESD perforation, post-EMR perforation；complications of endoscopic examination and procedure)
• American Society of Anesthesiology risk class 1, 2 or 3

Exclusion Criteria

• Patients <18 years
• Patients with thrombocytopenia (platelet count < 50,000/microL) or elevated - International Normalized Ratio (INR > 1.5)
• Hemodynamic instability
• Pregnancy and lactation
• Patients who are unable or unwilling to give an informed consent
• Chronic fistula following abdominal surgery
• Pyriform fossa perforation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Purse string suture device	Purse string suture device	Use of purse string suture device to close gastrointestinal perforation.
Endoclips	Endoclips	Use of endoclips to close gastrointestinal perforation.

Primary Outcome Measures

Name	Time	Method
Technique success rate	1 year	Percentage of patients who successfully receive endoscopical interventions

Secondary Outcome Measures

Name	Time	Method
Medical cost	1 year	The medical cost for the operation and hospitalization will be recorded and collected.
Operation time	1 year	The time length of the endoscopic operation will be recorded in the unit of minute.
Effective rate	1 year	Percentage of patients whose clinical symptoms are alleviated and perforations closed
Reoperation rate	1 year	Percentage of patients who need a secondary operation
Postoperative pain	1 year	Postoperative pain will be evaluated on a visula analogue score (VAS).
Postoperative complication rate	1 year	Percentage of patients who have complications including death after procedure
Postoperative hospitalization	1 year	The length of the hospitalizatioin after operation will be recorded in the unit of day.
Time to resume diet	1 year	When the patients resume diet will be monitored and recorded.

Trial Locations

Locations (1)

Department of gastroenterology,Affiliated Hospital to Academy of Military Medical Sciences; 🇨🇳 Beijing, China