A Trial on Prophylactic Clipping to Prevent Post-polypectomy Bleeding After Colonoscopy in Direct Oral Anticoagulant Users (PROCLIP)

  • STATUS
    Recruiting
  • End date
    Jun 14, 2023
  • participants needed
    584
  • sponsor
    Chinese University of Hong Kong
Updated on 9 April 2022

Summary

The investigators hypothesize that prophylactic clipping after colonoscopic polypectomy can reduce risk of delayed PPB among DOAC users. The investigators also hypothesize that pre-endoscopy drug level can predict the risk of hemorrhagic complications after the procedure.

Description

Endoscopic resection of colonic polyps has been shown to reduce colorectal cancer-related mortality. Despite the clinical benefit of colonoscopic polypectomy, post-polypectomy bleeding (PPB) occurs in up to 6.5% of patients. Current international guidelines classify polypectomy as one of the endoscopic procedures with high risk of hemorrhage.

Risk factors for PPB include advanced age, cardiovascular or renal diseases, large polyp size, pedunculated morphology, proximal location in right colon, and the use of antithrombotic medications. Among them, the use of oral anticoagulants such as warfarin and direct oral anticoagulants (DOAC) is associated with a substantially higher risk of PPB up to 13.7%.

While prophylactic clipping is often performed by endoscopists to reduce the PPB risk in clinical practice, the available evidence on its efficacy has been heterogenous and conflicting. A number of studies reported the efficacy of prophylactic clip closure after endoscopic resection to prevent PPB. On the contrary, several randomized trials did not demonstrate any significant benefit of prophylactic clipping. In recent meta-analyses, routine use of prophylactic clipping was not shown to decrease PPB risk, except in a subgroup of colonic lesion larger than 20mm and proximal to the hepatic flexure. However, the proportion of patients on oral anticoagulants was low (5.1%-26%) in the above studies, limiting the generalizability of results to this high-risk patient group. Our preliminary data involving >500 patients on oral anticoagulants showed a lower PPB risk in prophylactic clipping group among DOAC users (OR 0.26, 95%CI 0.09-0.67, p= 0.008).

Also, although the consensus is that DOAC users do not require routine drug level monitoring, studies have shown a positive correlation between plasma drug level and bleeding risks. In special circumstances, the measurement of anticoagulant effect would provide management guide, including patients with extreme body weight or renal impairment, imminent need of antidote reversal or before invasive surgical procedures. Diluted thrombin time and anti-factor Xa assays demonstrated a reasonable linear correlation with the plasma drug concentration, yet they are indirect tests. Specific DOAC drug level can be checked to provide direct measurement of anticoagulant effect. In the setting of elective invasive procedures, a pre-operative cutoff level (≦30 ng/mL) for dabigatran and rivaroxaban has been proposed. Patients undergoing interventions with high bleeding risks may benefit from drug level measurement by informing the operators to perform prophylactic measures to reduce hemorrhagic complications.

In this randomized controlled trial, we aim to evaluate the efficacy of prophylactic clipping in preventing PPB in colonoscopy among DOAC users. We also wish to investigate the correlation of pre-endoscopy DOAC drug level and the risk of hemorrhagic complications after the procedure.

Details
Condition Post Biopsy Bleeding
Treatment Endoclip
Clinical Study IdentifierNCT05169242
SponsorChinese University of Hong Kong
Last Modified on9 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

They are active users of any DOAC
They require elective colonoscopy for colorectal cancer screening, polyp surveillance, or investigation of symptoms such as anemia or past gastrointestinal bleeding
Aged 18 years old or above
Written informed consent obtained

Exclusion Criteria

Absolute contraindications to colonoscopy
Any medical conditions precluding interruption of DOAC for procedure
Any medical conditions requiring concomitant uninterrupted dual antiplatelet drugs (single antiplatelet drug users will not be excluded)
Active gastrointestinal bleeding
Clinically significant bleeding tendency (decompensated cirrhosis or severe thrombocytopenia)
Severe renal impairment (defined as creatinine clearance < 15 ml/min)
Pregnancy or lactation
Advanced comorbid conditions (defined as American Society of Anesthesiologists grade 4 or above)
Unable to obtain informed consent
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