Flexible Endoscopic Polidocanol Liquid and Foam Sclerotherapy for internal hemmhoids.

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

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/10/058768

Enrollment

Registered

2023-10-17

Start date

Unknown

Completion date

Unknown

Last updated

2023-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K77- Liver disorders in diseases classified elsewhere

Interventions

Intervention1: Sclerotherapy with 1.5% polidocanol.: 2mL (3%) polidocanol equals to 60mg

maximal dose: 1mL per column and 4mL per session. Duration:30 minutes Control Intervention1: Foam sclerotherapy.: Tessari’s technique

4mL 3% poilidocanol with 16mL air

maximal dose: 2mL per column and 20mL per session. Duration:30 minutes

Eligibility

Inclusion criteria

Inclusion criteria: 1) 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.

Exclusion criteria

Exclusion criteria: 1. Coagulopathy threshold of INR >2.0 and/or platelet count 2. Antiplatelet or anticoagulants use. 3. Immunosuppressive medications (including steroids >20mg/d or equivalent for >2 weeks). 4. Grade IV internal hemorrhoids. 5. Thrombosed or strangulated IH or EH. 6. Previous EST or RBL in last 1-year. 7. Co-existing ano-rectal diseases like perianal abscess, stricture, ?stula, anal malignancies, ano-rectal stenosis, radiation proctitis, or proctitis. 8. Patients not capable of understanding and signing the informed consent. 9. Pregnancy. 10. Bronchial Asthma.

Design outcomes

Primary

Measure	Time frame
No recurrence of hemorrhoidal bleeding episodes at 1-week after endotherapyTimepoint: 1 week	—

Secondary

Measure	Time frame
Adverse events/ local infectious complications after endotherapyTimepoint: 8 weeks;Ano-rectal bleeding at 4-wks, defined by Giamundo scoreTimepoint: 4 weeks;Ano-rectal bleeding at 8-wks, defined by Giamundo scoreTimepoint: 8 weeks;Proportion of cirrhotic patients with bleeding hemorrhoids, with coexisting rectal varices and/or portal colopathy.Timepoint: 8 weeks;Proportion of patients requiring a 2nd treatment session within 8-wks.Timepoint: 8 weeks;Proportion of patients requiring BT for hemorrhoidal bleeding within 8 wksTimepoint: 8 weeks;Proportion of patients with failed endotherapyTimepoint: 8 weeks;Relationship of MELD score (4-40) with no recurrence of bleeding at 7days.Timepoint: 7 days	—

Measure

Time frame

Adverse events/ local infectious complications after endotherapyTimepoint: 8 weeks;Ano-rectal bleeding at 4-wks, defined by Giamundo scoreTimepoint: 4 weeks;Ano-rectal bleeding at 8-wks, defined by Giamundo scoreTimepoint: 8 weeks;Proportion of cirrhotic patients with bleeding hemorrhoids, with coexisting rectal varices and/or portal colopathy.Timepoint: 8 weeks;Proportion of patients requiring a 2nd treatment session within 8-wks.Timepoint: 8 weeks;Proportion of patients requiring BT for hemorrhoidal bleeding within 8 wksTimepoint: 8 weeks;Proportion of patients with failed endotherapyTimepoint: 8 weeks;Relationship of MELD score (4-40) with no recurrence of bleeding at 7days.Timepoint: 7 days

—

Countries

India

Contacts

Public ContactDr Vikram Bhatia

Institute of Liver and Biliary Sciences

vikrambhatiadr@gmail.com01146300000

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026