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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Purse String Suture Device Versus Endoclip in the Treatment of Immediate Endoscopic Procedure Associated Gastrointestinal Perforation

Conditions
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Intervention, Gastrointestinal Perforation

Intervention / Treatment
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* Device: Purse string suture device
* Device: Endoclips


Participation Criteria
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Eligibility Criteria
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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

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: Purse string suture device<br>Use of purse string suture device to close gastrointestinal perforation. | Device: Purse string suture device<br>* Using purse string suture device to close gastrointestinal perforation under endoscopy.<br>|
| Active Comparator: Endoclips<br>Use of endoclips to close gastrointestinal perforation. | Device: Endoclips<br>* Using endoclips to close gastrointestinal perforation under endoscopy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technique success rate | Percentage of patients who successfully receive endoscopical interventions | 1 year | 

Secondary Outcome Measures

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