Polidocanol Foam in Hemorrhoidal Disease in Patients With Liver Cirrhosis

NCT05807425 | Unknown Phase 2

• 1 other identifier: 2021.051(041-DEFI/042-CE)
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Hemorrhoidal disease (HD) is a common health problem, affecting up to 38,9% of adult population. HD is also a common finding in up to 36% of cirrhotic patients, as hemorrhoidal plexus is a possible site of portosystemic venous anastomosis. Cirrhotic patients represent a group often neglected in clinical trials so, little is known about the optimal treatment for HD these patients. The objective of this study is to prospectively evaluate the efficacy and safety of treatment of grade I, II and III internal HD with polidocanol foam in cirrhotic patients.

Conditions

Hemorrhoids; Liver Cirrhosis

Keywords

Hemorrhoids; Liver Cirrhosis; Sclerotehrapy; Polidocanol foam

Outcome Measures

Primary Outcomes (2)

• Therapeutic success

  For efficacy evaluation during the intervention period the outcome of therapeutic success (improvement of HDSS) will be assessed; the therapeutic success is subdivided in: complete (HDSS = 0), partial (HDSS \> 0 but with improvement over the initial score) or unsuccess (participants that, after 3 sessions of office-based treatment worsened or maintained the initial HDSS

  9 weeks

• Incidence of Treatment Adverse Events

  Complications will be assessed and classified as: mild (e.g. pain/discomfort, minor bleeding, external hemorrhoidal thrombosis not requiring surgical intervention); moderate (e.g. external hemorrhoidal thrombosis requiring surgical intervention, moderate bleeding not requiring blood transfusion, urgent hemostasis or urgent surgery); and severe (e.g. sepsis, Fournier's gangrene, perineal abscess, bleeding with hemodynamic instability, transfusion need or urgent surgery, sexual impotence in man).

  9 weeks

Secondary Outcomes (3)

• Variation of Goligher classification (hemorrhoidal prolapse from grade 1 to grade 4)

  9 weeks

• Number of office-based therapy sessions

  9 weeks

• Hemorrhoidal disease recurrence

  1 year

Study Arms (1)

Polidocanol foam sclerotherapy

EXPERIMENTAL

A cohort of cirrhotic patients with hemorrhoidal disease will be treated with polidocanol foam sclerotherapy.

Procedure: Polidocanol foam sclerotherapy

Interventions

Polidocanol foam sclerotherapy PROCEDURE

The preparation of the foam is done according to the Tessari's technique using 2 disposable 20ml syringe, a three-way tap and a 10cm reusable extender adapted to intravenous needle. The sclerosant is applied according to the Blanchard's technique through a disposable transparent anoscope with the patient in jack-knife (knee-chest) position. In each session treatment can be performed on more than one hemorrhoidal cushion. The maximum dose per treatment session is 20ml (mixture of 4ml of polidocanol 3% with 16ml of air).

Polidocanol foam sclerotherapy

Eligibility Criteria

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

You may qualify if:

• Adult patients with liver cirrhosis and symptomatic HD grades I to III
• Refractory to conservative therapy (dietary modification, intestinal transit modifiers, topical and phlebotonics), during a period of 4 weeks

You may not qualify if:

• Known allergy to polidocanol
• Pregnant and lactating women
• Inflammatory bowel disease
• Other concomitant symptomatic perianal disease
• History of office-based or surgical treatment of hemorrhoidal disease in the last 6 months
• Immunosuppression

Sponsors & Collaborators

• Universidade do Porto: lead

Study Sites (1)

Centro Hospitalar Universitário do Porto

Porto, 4050-000, Portugal

RECRUITING

Related Publications (15)

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  PMID: 11040208 BACKGROUND

• Rorvik HD, Styr K, Ilum L, McKinstry GL, Dragesund T, Campos AH, Brandstrup B, Olaison G. Hemorrhoidal Disease Symptom Score and Short Health ScaleHD: New Tools to Evaluate Symptoms and Health-Related Quality of Life in Hemorrhoidal Disease. Dis Colon Rectum. 2019 Mar;62(3):333-342. doi: 10.1097/DCR.0000000000001234.

  PMID: 30451751 BACKGROUND

• Huang WS, Lin PY, Chin CC, Yeh CH, Hsieh CC, Chang TS, Wang JY. Stapled hemorrhoidopexy for prolapsed hemorrhoids in patients with liver cirrhosis; a preliminary outcome for 8-case experience. Int J Colorectal Dis. 2007 Sep;22(9):1083-9. doi: 10.1007/s00384-007-0271-5. Epub 2007 Mar 2.

  PMID: 17334772 BACKGROUND

• Awad AE, Soliman HH, Saif SA, Darwish AM, Mosaad S, Elfert AA. A prospective randomised comparative study of endoscopic band ligation versus injection sclerotherapy of bleeding internal haemorrhoids in patients with liver cirrhosis. Arab J Gastroenterol. 2012 Jun;13(2):77-81. doi: 10.1016/j.ajg.2012.03.008. Epub 2012 Apr 24.

  PMID: 22980596 BACKGROUND

• Fernandes V, Fonseca J. Polidocanol Foam Injected at High Doses with Intravenous Needle: The (Almost) Perfect Treatment of Symptomatic Internal Hemorrhoids. GE Port J Gastroenterol. 2019 May;26(3):169-175. doi: 10.1159/000492202. Epub 2018 Aug 31.

  PMID: 31192285 BACKGROUND

• Salgueiro P, Garrido M, Santos RG, Pedroto I, Castro-Pocas FM. Polidocanol Foam Sclerotherapy Versus Rubber Band Ligation in Hemorrhoidal Disease Grades I/II/III: Randomized Trial. Dis Colon Rectum. 2022 Jul 1;65(7):e718-e727. doi: 10.1097/DCR.0000000000002117. Epub 2022 Nov 22.

  PMID: 34840294 BACKGROUND

• Salgueiro P, Rei A, Garrido M, Rosa B, Oliveira AM, Pereira-Guedes T, Morais S, Castro-Pocas F. Polidocanol foam sclerotherapy in the treatment of hemorrhoidal disease in patients with bleeding disorders: a multicenter, prospective, cohort study. Tech Coloproctol. 2022 Aug;26(8):615-625. doi: 10.1007/s10151-022-02600-5. Epub 2022 Feb 25.

  PMID: 35217937 BACKGROUND

• Neves S, Falcao D, Povo A, Castro-Pocas F, Oliveira J, Salgueiro P. 3% polidocanol foam sclerotherapy versus hemorrhoidal artery ligation with recto anal repair in hemorrhoidal disease grades II-III: a randomized, pilot trial. Rev Esp Enferm Dig. 2023 Mar;115(3):115-120. doi: 10.17235/reed.2022.8568/2022.

  PMID: 35638762 BACKGROUND

• Salgueiro P, Ramos MI, Castro-Pocas F, Libanio D. Office-Based Procedures in the Management of Hemorrhoidal Disease: Rubber Band Ligation versus Sclerotherapy - Systematic Review and Meta-Analysis. GE Port J Gastroenterol. 2022 Mar 8;29(6):409-419. doi: 10.1159/000522171. eCollection 2022 Nov.

  PMID: 36545183 BACKGROUND

• Salgueiro P, Caetano AC, Oliveira AM, Rosa B, Mascarenhas-Saraiva M, Ministro P, Amaro P, Godinho R, Coelho R, Gaio R, Fernandes S, Fernandes V, Castro-Pocas F. Portuguese Society of Gastroenterology Consensus on the Diagnosis and Management of Hemorrhoidal Disease. GE Port J Gastroenterol. 2020 Feb;27(2):90-102. doi: 10.1159/000502260. Epub 2019 Sep 5.

  PMID: 32266306 BACKGROUND

MeSH Terms

Conditions

Hemorrhoids; Liver Cirrhosis

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Vascular Diseases; Cardiovascular Diseases; Liver Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Paulo Salgueiro, MD PhD

  Centro Hospitalar Universitário de Santo António

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paulo Salgueiro, MD PhD

CONTACT

00351222077500; paulosalgueiro@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: During the intervention period the participants are observed at 3-week intervals (maximum of 3 sessions). The required number of sessions (maximum of 3) is determined by clinical and anoscopic evaluation (if the participant is non-symptomatic and/or there is no significant hemorrhoidal disease on anoscopy, the patient will not be a candidate for additional instrumental therapy moving directly to the follow-up period). After the intervention period, a one-year follow-up is scheduled with medical appointments performed every 3 months.

Study Record Dates

• First Submitted: March 21, 2023
• First Posted: April 11, 2023
• Study Start: March 31, 2023
• Primary Completion: September 30, 2023
• Study Completion: December 31, 2023
• Last Updated: April 11, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)