To Describe the Clinical, Endoscopic and Endoscopic Ultrasound Features of Non-bleeding and Bleed… (NCT04535440) | Clinical Trial Compass
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To Describe the Clinical, Endoscopic and Endoscopic Ultrasound Features of Non-bleeding and Bleeding Rectal Varices, Among Patients With Portal Hypertension
India100 participantsStarted 2021-01-07
Plain-language summary
Rectal varices (RVs) are an important cause of lower gastrointestinal bleed (LGIB) in portal hypertension (PHT) and have been reported to occur in 44% to 89% of cases of cirrhosis. RVs are dilated sub-mucosal porto-systemic communications which extend from mid rectum to the ano-rectal junction and are considered distinct from internal hemorrhoids, which are submucosal arterio-venous communications of the anorectal vascular plexus. The suspicion of RVs as the cause of bleeding can be made with a high index of suspicion when lower GI bleed is seen in absence of hemorrhoids, and colonoscopy shows blood in rectum. Bleeding usually happens from endoscopically evident rectal varices (EERV) but sometimes bleed can occur from varices, which are endoscopically in evident (EIERV). Endoscopic ultrasound (EUS) has been shown to be more sensitive in diagnosis of EIERV. Endoscopic and EUS correlation of RVs has shown that RVs, classified as tortuous, nodular, and tumorous on endoscopic examination, have corresponding appearances on rectal EUS as single, multiple, and innumerable submucosal veins, respectively. The hemodynamic evaluation (HDE) of RVs by EUS is routinely done at some centers to assess parameters like the site, size, velocity, or direction of flow.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Age \>18-years.
✓. Patients with PHT and active or prior anorectal bleeding in preceding 6-months.
✓. Patients with RV (bleeding or non-bleeding) detected on LGI endoscopy.
✓. Ability to understand study procedures, and to comply with them for the entire length of the study.
Exclusion criteria
✕. Peri-anal infection, peri-anal warts, anal condyloma, or fistulizing disease.
✕. Proctitis- infective, inflammatory bowel disease (IBD), radiation, or unspecified.
✕. Pregnant or lactating females.
✕. Presence of hemodynamic instability.
✕. Presence of encephalopathy
✕. Non-consenting adult patient or guardian.
✕
What they're measuring
1
Anatomical and liver -related risk-factors for presence of rectal varices (RV) among patients with portal hypertension
Timeframe: Day 1
Trial details
NCT IDNCT04535440
SponsorInstitute of Liver and Biliary Sciences, India