Purse String Suture Device vs. Endoclip for Immediate Endoscopic Procedure Associated Gastrointestinal Perforation
Purse String Suture Device Versus Endoclip in the Treatment of Immediate Endoscopic Procedure Associated Gastrointestinal Perforation
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2017
CompletedFirst Submitted
Initial submission to the registry
February 8, 2017
CompletedFirst Posted
Study publicly available on registry
February 15, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2018
CompletedFebruary 15, 2017
February 1, 2017
8 months
February 8, 2017
February 10, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Technique success rate
Percentage of patients who successfully receive endoscopical interventions
1 year
Secondary Outcomes (8)
Effective rate
1 year
Postoperative complication rate
1 year
Reoperation rate
1 year
Operation time
1 year
Postoperative pain
1 year
- +3 more secondary outcomes
Study Arms (2)
Purse string suture device
EXPERIMENTALUse of purse string suture device to close gastrointestinal perforation.
Endoclips
ACTIVE COMPARATORUse of endoclips to close gastrointestinal perforation.
Interventions
Using purse string suture device to close gastrointestinal perforation under endoscopy.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of gastroenterology,Affiliated Hospital to Academy of Military Medical Sciences
Beijing, 100071, China
Related Publications (2)
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.
PMID: 26441181BACKGROUNDTan 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.
PMID: 27504848BACKGROUND
Study Officials
- PRINCIPAL INVESTIGATOR
Yan Liu, M.D., Ph.D.
Affiliated Hospital to Academy of Military Medical Sciences
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 8, 2017
First Posted
February 15, 2017
Study Start
February 1, 2017
Primary Completion
October 1, 2017
Study Completion
January 1, 2018
Last Updated
February 15, 2017
Record last verified: 2017-02
Data Sharing
- IPD Sharing
- Will not share