To Describe the Clinical, Endoscopic and Endoscopic Ultrasound Features of Non-bleeding and Bleeding Rectal Varices, Among Patients With Portal Hypertension

NCT04535440 | Unknown

• 1 other identifier: ILBS-PHT-01
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Liver Diseases

Outcome Measures

Primary Outcomes (1)

• Anatomical and liver -related risk-factors for presence of rectal varices (RV) among patients with portal hypertension

  Day 1

Secondary Outcomes (4)

• Etiological spectrum of bleeding per-rectum, among patients with PHT.

  Day 1

• Frequency of coexistence of hemorrhoids with Rectal varices

  Day 1

• Distribution and size of variceal channels in the rectum on endoscopy and endoscopic ultrasound (EUS).

  Day 1

• Location and numbers of inflow and outflow perforator channels for RV on endoscopic ultrasound (EUS).

  Day 1

Study Arms (2)

Rectal varices with bleed

Other: No intervention

Rectal varices without bleed

Other: No intervention

Interventions

No intervention OTHER

No intervention

Rectal varices with bleed; Rectal varices without bleed

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients with PHT (cirrhotic or non-cirrhotic), with active or prior anorectal bleeding (defined later) in the preceding 6-months will be evaluated for inclusion. We will also include patients with incidental detection of RV during endoscopy done for other indications. We will include both indoor and outdoor patients, attending the Department of Hepatology, ILBS, New Delhi. An informed consent will be obtained from the participants in the study.

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Prior history of banding or surgery for hemorrhoids, or endotherapy for RV.
• Prior shunt occlusion procedures like BRTO or PARTO, or shunt creation procedures like TIPS.

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

Study Sites (1)

Institute of Liver & Biliary Sciences

New Delhi, National Capital Territory of Delhi, 110070, India

RECRUITING

MeSH Terms

Conditions

Liver Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Central Study Contacts

Dr Hitesh Singh, MD

CONTACT

01146300000; hiteshrims04@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2020
• First Posted: September 2, 2020
• Study Start: January 7, 2021
• Primary Completion: July 31, 2022
• Study Completion: July 31, 2022
• Last Updated: October 12, 2021

Record last verified: 2021-10

Locations

IN (1)