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Gastrointestinal Endoscopy ; 95(6):AB189, 2022.
Article in English | EMBASE | ID: covidwho-1885785

ABSTRACT

DDW 2022 Author Disclosures: Dennis Jensen: NO financial relationship with a commercial interest ;Rome Jutabha: NO financial relationship with a commercial interest ;Gareth Dulai: NO financial relationship with a commercial interest ;Noam Jacob: NO financial relationship with a commercial interest ;Jeffrey Gornbein: NO financial relationship with a commercial interest Background and Aims: The best strategy to prevent DPPIUH is controversial. Some colonoscopists recommend hemoclip closure of PPIU’s but this has mixed success rates in different RCT’s and is reported not to be cost effective. In addition to known risks, arterial blood flow detected in PPIU’s is an important predictor of DPPIUH. Our AIMS are to report study methods and interim results of a RCT of blood flow monitoring to prevent DPPIUH. Methods: This is an ongoing blinded RCT at several major Los Angeles Medical Centers by experienced colonoscopists. Outpatients having colonoscopies are screened and consented for enrollment. Sessile and multilobulated polyps are removed by EMR techniques. Thermal coagulation is used for polypectomies in this study. Randomized patients are stratified by whether they take chronic anti-platelet or anti-thrombotic drugs and have PPIU’s of 10-40 mm;or those without bleed drugs and have PPIU’s between 15-40 mm. By opening a sealed envelope after polypectomies, randomization is to either standard management (e.g. following ASGE guidelines of bleed drugs) or DEP interrogation of the PPIU and guided treatment of the artery with hemoclips or multipolar probe coagulation in the PPIU until blood flow is eradicated. Patients and their care givers were blinded to treatments allocated during colonoscopy. Prospective follow-up is by a research coordinator contacting each patient at 7, 14, and 30 days to record whether any complications (e.g. pain, vomiting, or bleeding);or rectal bleeding and its severity (e.g. # and days of bloody BM’s);whether they sought ER, clinic, or telemedicine care for bleeding;or were hospitalized. Major DPPIUH was diagnosed in patients with hospitalization for severe bleeding and/or for 3 or more days of ongoing severe rectal bleeding but refusal of hospitalization because of high rates of COVID here. Demographic, laboratory, colonoscopic, and pathology results are recorded on standard forms along with 30-day outcomes. Patients are assigned a code, data are entered onto HIPAA compliant computer files by a data manager and managed with SAS. With half the projected sample size randomized and followed up (e.g. 133 of 268 total), this is a planned interim analysis of the primary outcome - rates of DPPIUH by treatment. Severe adverse events (SAE’s) were also reviewed. Results: For 133 high risk patients randomized to date, 67 are in the standard group and 66 in the DEP group. The groups were well matched in risk factors – see Table 1. Overall, the Doppler group had lower rates of delayed PPIU bleeding – both major and total- see Table 2. There were no SAE’s. Conclusions: The major DPPIUH rate was higher with standard treatment than DEP treatment (7.46 % vs. 0 %), as was the rate of Total DPPIUH (10.45 % vs. 1.52%). Based upon these promising results, this RCT will continue. [Formula presented] [Formula presented]

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