Clinical trial NCT03053232: Purse String Suture Device vs. Endoclip for Immediate Endoscopic Procedure Associated Gastrointestinal Perforation
Official title: Purse String Suture Device Versus Endoclip in the Treatment of Immediate Endoscopic Procedure Associated Gastrointestinal Perforation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Intervention
Gastrointestinal Perforation
Lead sponsor: Affiliated Hospital to Academy of Military Medical Sciences
Sponsor class: OTHER
First posted: 2017-02-15
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Technique success rate
timeFrame: 1 year
Secondary outcomes:
measure: Effective rate
timeFrame: 1 year
measure: Postoperative complication rate
timeFrame: 1 year
measure: Reoperation rate
timeFrame: 1 year
measure: Operation time
timeFrame: 1 year
measure: Postoperative pain
timeFrame: 1 year
measure: Postoperative hospitalization
timeFrame: 1 year
measure: Time to resume diet
timeFrame: 1 year
measure: Medical cost
timeFrame: 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Department of gastroenterology,Affiliated Hospital to Academy of Military Medical Sciences
Study officials:
affiliation: Affiliated Hospital to Academy of Military Medical Sciences
name: Yan Liu, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schultz JK, Yaqub S, Wallon C, Blecic L, Forsmo HM, Folkesson J, Buchwald P, Korner H, Dahl FA, Oresland 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.
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. Epub 2016 Aug 5.