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NCT04535440
To Describe the Clinical, Endoscopic and Endoscopic Ultrasound Features of Non-bleeding and Bleeding Rectal Varices, Among Patients With Portal Hypertension
trial testing No intervention in Liver Diseases in 100 participants. Status unknown.
31 July 2022
Quick facts
| Lead sponsor | Institute of Liver and Biliary Sciences, India |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 100 |
| Start date | 7 January 2021 |
| Primary completion | 31 July 2022 |
| Estimated completion | 31 July 2022 |
| Sites | 1 location across India |
Drugs / interventions tested
- No intervention
Conditions studied
- Liver Diseases — all drugs for Liver Diseases →
Sponsor
Institute of Liver and Biliary Sciences, India
Who can join
18 and older, any sex, with Liver Diseases. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04535440
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04535440 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Institute of Liver and Biliary Sciences, India
- Last refreshed: 12 October 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04535440.
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