Prophylactic Clip Application for Colon Polypectomy in Patients With Anticoagulation

NCT02120170 | Unknown DMC

• 1 other identifier: CLIPO
• Study Type: interventional
• Target: 356
• Locations: 1 country
• Sites: 1

Brief Summary

There have been very limited evidence about the bleeding complication during colon polypectomy for the patients taking warfarin. This study is aimed to analyse the effect of prophylactic hemo-clipping during colon polypectomy for the patients with warfarin consumption. The enrolled subjects are the patients who take warfarin for high thromboembolism risk and should take heparin bridging therapy during colon polypectomy instead of temporary stopping warfarin. The investigators will randomize into two groups; the patient enrolled into group 1 will be performed hemoclipping for all polypectomy lesion irrespective of the presence of immediate bleeding. And the patients enrolled into group 2 will be performed hemoclipping only for the lesion of immediate bleeding during colon polypectomy. The primary endpoint is to compare the rate of delayed bleeding between two groups.

Conditions

Colon Polyp

Keywords

Hemoclip, Heparin bridging therapy, colon polypectomy, warfarin

Outcome Measures

Primary Outcomes (1)

• Number of participants with delayed bleeding

  The primary endpoint is to compare the rate of delayed bleeding between two groups.

  Bleeding within 30 days after colon polypectomy

Secondary Outcomes (1)

• Number of successful bleeding control after hemoclipping for immediate bleeding in the patients with warfarin.

  Bleeding during the procedure

Other Outcomes (1)

• Cut-off value of resuming timing of warfarin after colon polypectomy

  Within 1 week after polypectomy

Study Arms (2)

Hemoclipping during colon polypectomy for all lesion

ACTIVE COMPARATOR

The enrolled patients of group 1 will be performed hemoclipping for all polypectomy lesion irrespective of the presence of immediate bleeding.

Procedure: Colon polypectomy

No hemoclipping if there were no bleeding during polypectomy

NO INTERVENTION

The patients of group 2 will be performed hemoclipping only for the immediate bleeding during colon polypectomy

Interventions

Colon polypectomy PROCEDURE

Hemoclipping during colon polypectomy for all lesion

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• subjects who should take heparin bridging therapy after quit warfarin 3\~5 days before colon polypectomy because of high risk of thromboembolism - AF with valvular disease, AF with mechanical valve, AF with CHF, EF \<35%, AF with previous thromboembolism, AF with DM and HTN, AF with old age(\>75),

You may not qualify if:

• patients who don't have to take bridging heparin therapy after quit warfarin, patients have low a platelet count (\<80,000/mm3), patients who take anti-platelet agents, patients who have GI malignancies.

Sponsors & Collaborators

• Soonchunhyang University Hospital: lead

Study Sites (1)

Soonchunhyang University Hospital

Seoul, Seoul, 140-743, South Korea

Location

MeSH Terms

Conditions

Colonic Polyps

Condition Hierarchy (Ancestors)

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

Study Officials

• Hyun Gun Kim, MD.,PhD.

  Soonchunhyang University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

HYUN GUN KIM, MD.,PhD.

CONTACT

8227099852; medgun@schmc.ac.kr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: March 27, 2014
• First Posted: April 22, 2014
• Study Start: April 1, 2014
• Primary Completion: March 1, 2017
• Study Completion: April 1, 2017
• Last Updated: April 23, 2014

Record last verified: 2014-04

Locations

KR (1)