EndoClot for Preventing Rebleeding After Endoscopic Mucosal Resection (EMR)

NCT01735786 | Completed DMC

• 1 other identifier: 20121125
• Study Type: observational
• Target: 164
• Locations: 1 country
• Sites: 1

Brief Summary

Endoscopic mucosal resection (EMR) has been widely used as a diagnostic and treatment techniques of gastrointestinal small lesions. Postoperative rebleeding is one of the common complication following EMR. Several endoscopic hemostasis methods are currently in use. EndoClot® absorbable polysaccharide hemostat (PAPH) as a new hemostasis material was previously used for surgical hemostasis, but the therapeutic effect and safety in endoscopic application remains unknown. This study has been designed to observe the effect of rebleeding prevention after EMR.

Conditions

Endoscopic Hemostasis; Colonic Polyps

Keywords

Endoscopic Hemostasis; EndoClot Absorbable Polysaccharide Hemostat; Colonic Polyps

Outcome Measures

Primary Outcomes (1)

• Rebleeding rate after EMR procedure

  Rebleeding rate up to 1 week was obtained by clinical manifestations such as melana; decreased hemoglobin \> 20g/L; hemodynamic instability or active bleeding from mucosal defect under endoscope.

  up to 1 week

Secondary Outcomes (2)

• Mucosal healing after EMR

  up to 1 month

• gastrointestinal tract obstruction

  up to 1 month

Study Arms (2)

Treatment group

Subjects in this group will received Endoclot treatment immediately after EMR.

Device: EndoClot

Control group

Subjects in this group will not received any hemostasis treatment after EMR.

Interventions

EndoClot DEVICE

EndoClot hemostat is applied immediately after EMR to achieve hemostasis.

Treatment group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Consecutive cases of colorectal mucosal and submucosal lesions with intented EMR treatment

You may qualify if:

• consecutive cases of colorectal polyps and submucosal lesions with anticipated complete removal endoscopically by EMR.

You may not qualify if:

• severe cardiovascular diseases, liver and kidney dysfunction;
• platelet and coagulation dysfunction (PLT \< 50\*109/L, INR \> 2);
• cases that have taken anticoagulant drugs or non-steroidal anti-inflammatory drugs within 1 month before the procedure;
• cases unavailable for follow-up.

Sponsors & Collaborators

• Xijing Hospital of Digestive Diseases: lead

Study Sites (1)

Xijing Hospital of Digestive Diseases

Xi’an, Shanxi, 710032, China

Location

MeSH Terms

Conditions

Colonic Polyps

Condition Hierarchy (Ancestors)

Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Zhiguo Liu, M.D.

  Xijing Hospital of Digestive Diseases, Xi'an, Shaanxi, China 710032

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated Professor

Study Record Dates

• First Submitted: November 25, 2012
• First Posted: November 28, 2012
• Study Start: April 1, 2010
• Primary Completion: February 1, 2012
• Study Completion: March 1, 2012
• Last Updated: November 28, 2012

Record last verified: 2012-11

Locations

CN (1)