Prophylactic Clip Application for Colon Polypectomy in Patients With Anticoagulation

Colon Polyp Clinical Trial

Official title:

The Effect of Prophylactic Clip Application for Colon Polypectomy in Patients With Anticoagulation: Prospective Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02120170
• Other study ID #: CLIPO
• Status: Not yet recruiting
• Phase: N/A
• First received: March 27, 2014
• Last updated: April 21, 2014
• Start date: April 2014
• Est. completion date: April 2017

Study information

• Verified date: April 2014
• Source: Soonchunhyang University Hospital
• Contact: HYUN GUN KIM, MD.,PhD.
• Phone: 8227099852
• Email: medgun[@]schmc.ac.kr
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial 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.

Description:

The American guideline have recommended that if the patient with low risk of thromboembolism, warfarin consumption can be quit 3~5 days before colon polypectomy and resume within 24 hours after polypectomy. However, if the patient were high risk of thromboembolism, the patient should take heparin bridging therapy during temporal quit of warfarin consumption for colon polypectomy. There have been very limited evidences about the bleeding complication during colon polypectomy for the patients with warfarin taking.

Moreover, there have been lack of evidence that how to prevent the bleeding complication in the patients with high risk of thromboembolism who should take heparin bridging therapy during temporal stopping of warfarin for colon polypectomy.

This study is aimed to analyse the effect of prophylactic hemo-clipping during colon polypectomy for the patients with warfarin consumption.

The investigators will enroll the subjects who should take heparin bridging therapy (quit warfarin 3~5 days before colon polypectomy and check the INR, if the INR <2, heparin or low molecular heparin should be start. If the INR <1.5 on the day before colon polypectomy, the patient will undergo bowel preparation and colon polypectomy. Warfarin will resume within 24 hour after polypectomy) after quit warfarin for during colon polypectomy over 19 years old.

Exclusions are as follow; 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. 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. Including polyps for colon polypectomy are 6~ 20 mm size and polypectomy procedure is defined as EMR after injection with blended electrical current.

The lesion which immediate bleeding is occurred during the polypectomy will be performed hemoclipping irrespective of group and will not be counted as delayed bleeding even though delayed bleeding is occurred on this lesion.

The primary endpoint is to compare the rate of delayed bleeding between two groups. The secondary endpoint is to analyse the effect of hemoclipping for immediate bleeding.

This study will be performed during 3 years after 1st patient enrollment and the target size of enrollment is 356 (176 in each group).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 356
• Est. completion date: April 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• 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),

Exclusion Criteria:

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colon Polyp

Intervention

Procedure:
• Colon polypectomy

Locations

Country	Name	City	State
Korea, Republic of	Soonchunhyang University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Soonchunhyang University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cut-off value of resuming timing of warfarin after colon polypectomy	The guideline recommended warfarin resuming within 24 hours after colon polypectomy, But there is very limited evidence about safe timing of warfarin resuming regarding the bleeding complication.	Within 1 week after polypectomy	No
Primary	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	No
Secondary	Number of successful bleeding control after hemoclipping for immediate bleeding in the patients with warfarin.	The secondary endpoint is to analyse the effect of hemoclipping for immediate bleeding and will be measured as successful hemostasis rate of hemoclipping. There has limited evidence about the efficacy of hemoclipping for the immediate bleeding during colon polypectomy in the patients with anticoagulation	Bleeding during the procedure	No