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

Intervention Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03053232
• Other study ID #: 307-LM
• Status: Recruiting
• Phase: N/A
• First received: February 8, 2017
• Last updated: February 10, 2017
• Start date: February 1, 2017
• Est. completion date: January 2018

Study information

• Verified date: February 2017
• Source: Affiliated Hospital to Academy of Military Medical Sciences
• Contact: Xiaotian Sun, M.D., Ph.D.
• Phone: +86-010-66947473
• Email: xiaotian-sun[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 2018
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gastrointestinal Perforation
• Intervention

Intervention

Device:
• Purse string suture device
Using purse string suture device to close gastrointestinal perforation under endoscopy.
• Endoclips
Using endoclips to close gastrointestinal perforation under endoscopy.

Locations

Country	Name	City	State
China	Department of gastroenterology,Affiliated Hospital to Academy of Military Medical Sciences	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Affiliated Hospital to Academy of Military Medical Sciences

Country where clinical trial is conducted

China, 

References & Publications (2)

Schultz JK, Yaqub S, Wallon C, Blecic L, Forsmo HM, Folkesson J, Buchwald P, Körner H, Dahl FA, Øresland T; SCANDIV Study Group.. Laparoscopic Lavage vs Primary Resection for Acute Perforated Diverticulitis: The SCANDIV Randomized Clinical Trial. JAMA. 2015 Oct 6;314(13):1364-75. doi: 10.1001/jama.2015.12076. — View Citation

Tan S, Wu G, Zhuang Q, Xi Q, Meng Q, Jiang Y, Han Y, Yu C, Yu Z, Li N. Laparoscopic versus open repair for perforated peptic ulcer: A meta analysis of randomized controlled trials. Int J Surg. 2016 Sep;33 Pt A:124-32. doi: 10.1016/j.ijsu.2016.07.077. Review. — View Citation

Outcome

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