A Comparison of Flexible Endoscopic Polidocanol Liquid and Foam Sclerotherapy in Cirrhotic Patients With Bleeding From Internal Hemorrhoids

NCT06031740 | Unknown

• 1 other identifier: ILBS-Cirrhosis-63
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Haemorrhoids are the most common proctologic disease, affecting up to 36% of people in the developed world. Sclerotherapy is defined as the injection of sclerosing agents at the apex of the internal hemorrhoidal complex, above the dentate line, leading to scarring, fibrosis, and fixation of the hemorrhoids. Sclerotherapy as a treatment of internal hemorrhoids has been used for a long time by surgeons, using proctoscopic exposure. Even though flexible instruments can be expected to have better manoeuvrability and target site exposure. There is no consensus amongst the major guidelines as to which grade of haemorrhoid that sclerotherapy should be used, whether it is equivalent or inferior to rubber bad ligation (RBL), whether sclerotherapy should be used at all for the treatment of IH, what is the effect of PHT on hemorrhoid prevalence and propensity to bleed, differentiation of internal hemorrhoids from rectal varices, data on EBL or EST in cirrhotics with hemorrhoids, safety of endotherapy with underlying coagulopathy and concerns for infectious complications.

Conditions

Liver Cirrhosis; Internal Hemorrhoid

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with no recurrence of hemorrhoidal bleeding episodes at 1 week after endotherapy.

  1 week

Secondary Outcomes (8)

• Number of participants with ano-rectal bleeding at 4 weeks, defined by giamundos core [ Ordinal score from 0-4 ; Higher score meaning worse outcome

  4 weeks

• Number of participants with ano-rectal bleeding at 8 weeks, defined by giamundos core [ Ordinal score from 0-4 ; Higher score meaning worse outcome

  8 weeks

• Proportion of patients requiring a 2nd treatment session within 8 weeks

  8 weeks

• Proportion of patients with failed endotherapy.

  8 weeks

• Proportion of patients requiring BT for hemorrhoidal bleeding within 8 weeks.

  8 weeks

Study Arms (2)

Sclerotherapy with 1.5% polidocanol.

EXPERIMENTAL

2mL (3%) polidocanol = 60mg; maximal dose: 1mL/column and 4mL/session.

Procedure: Sclerotherapy with 1.5% polidocanol

Foam sclerotherapy

ACTIVE COMPARATOR

Tessari's technique; 4mL 3% poilidocanol +16mL air; maximal dose: 2mL/column and 20mL/session.

Procedure: Foam sclerotherapy.

Interventions

Sclerotherapy with 1.5% polidocanol PROCEDURE

2mL (3%) polidocanol = 60mg; maximal dose: 1mL/column and 4mL/session. \- Group 2: Foam sclerotherapy.

Sclerotherapy with 1.5% polidocanol.

Foam sclerotherapy. PROCEDURE

Tessari's technique; 4mL 3% poilidocanol +16mL air; maximal dose: 2mL/column and 20mL/session.

Foam sclerotherapy

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Cirrhotic/ACLF patients with ano-rectal bleeding, either ongoing or within last 1-week, judged to be hemorrhoidal in origin based on clinical features and endoscopy evaluation.

You may not qualify if:

• Coagulopathy threshold of INR \>2.0 and/or platelet count \<50,000/mm3.
• Antiplatelet or anticoagulants use.
• Immunosuppressive medications (including steroids \>20mg/d or equivalent for \>2 weeks).
• Grade IV internal hemorrhoids.
• Thrombosed or strangulated IH or EH.
• Previous EST or RBL in last 1-year.
• Co-existing ano-rectal diseases like perianal abscess, stricture, fistula, anal malignancies, ano-rectal stenosis, radiation proctitis, or proctitis.
• Patients not capable of understanding and signing the informed consent.
• Pregnancy.
• Bronchial Asthma.

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

Study Sites (1)

Institute of Liver & Biliary Sciences (ILBS)

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

Location

MeSH Terms

Conditions

Liver Cirrhosis

Interventions

Sclerotherapy; Polidocanol

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics; Polyethylene Glycols; Ethylene Glycols; Glycols; Alcohols; Organic Chemicals; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Central Study Contacts

Dr Srajit Singh, MD

CONTACT

01146300000; srajitsinghparmar@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2023
• First Posted: September 11, 2023
• Study Start: September 7, 2023
• Primary Completion: August 31, 2024
• Study Completion: August 31, 2024
• Last Updated: September 15, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)