Clinical trial NCT05807425: Polidocanol Foam in Hemorrhoidal Disease in Patients With Liver Cirrhosis
Official title: Sclerotherapy With Polidocanol Foam in the Treatment of First, Second and Third-Grade Hemorrhoidal Disease in Patients With Liver Cirrhosis: A Prospective, Cohort Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Hemorrhoids
Liver Cirrhosis
Keywords: Hemorrhoids
Liver Cirrhosis
Sclerotehrapy
Polidocanol foam
Lead sponsor: Universidade do Porto
Sponsor class: OTHER
First posted: 2023-04-11
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Detailed description: Hemorrhoidal disease (HD) is a common health problem, affecting up to 38,9% of adult population. Despite being a benign condition, associated symptoms like bleeding, pain, prolapsing, swelling, itching, and mucus soiling impact considerably on patients' quality of life. HD is also a common finding in up to 36% of cirrhotic patients, as hemorrhoidal plexus is a possible site of portosystemic venous anastomosis. Despite portal hypertension does not increase the prevalence of hemorrhoids, elevated portal venous pressure, with a not so rare contribution of coagulopathy, may result in massive, life-threatening hemorrhoidal bleeding, unlike the normal population. Besides, internal HD bleeding is the most frequently identified cause of bleeding with origin on the lower gastrointestinal tract among cirrhotic patients with severe hematochezia .

HD treatment can be grouped into conservative (diet, lifestyle changes, laxatives, anti-inflammatory drugs, phlebotonics), office-based (sclerotherapy, ligation, photocoagulation, laser photocoagulation, among others) and surgical (hemorrhoidectomy, hemorrhoidopexy). The choice of therapy should be oriented by the Goligher's classification, or a symptom score such as Rørvik's Hemorrhoidal Disease Symptom Score (HDSS).

Cirrhotic patients represent a group often neglected in clinical trials so, little is known about the optimal treatment for HD these patients. Surgical treatment with stapled hemorrhoidopexy has been described in cirrhotic patients as a feasible and safe approach, but with up to 46,7% of the procedures complicated with postoperative staple-line bleeding, although all of them managed with conservative treatment without reoperation or death. Recently, Ashraf et al compared hemorrhoidectomy performed using rubber band ligation (RBL) with conventional hemorrhoidectomy in 40 randomized patients with liver disease and diagnosed with grade I, II, or III HD. Intraoperative blood loss was lower in RBL group (1.2 ± 1.6 ml vs 22.2 ± 6.58 ml, p=0,001), as well as operative time (9.00 ± 2.449 min vs 24.100 ± 3.669 min, p=0,001). Importantly, postoperative pain (35% vs 100%, p=0,001), bleeding (15% vs 45%, p=0,022) and urine retention (20% vs 55%, p=0,011) were lower in the RBL group, along with time of hospital stay (8.6 ± 2.54 h vs 60.65 ± 41.93, p=0,002) and time of wound healing (16.85 ± 1.87 days vs 31.00 ± 3.57 days, p=0,003).

Bearing in mind the high rate of surgical complications in cirrhotic patients, these results suggest that office-based treatments, may be the preferred treatment for cirrhotic patients with HD grades I to III. Awad et al, compared the efficacy of endoscopic injection sclerotherapy (EIS) to RBL in the treatment of bleeding internal hemorrhoids in 120 adult patients with liver cirrhosis. Both techniques were highly effective in the control of bleeding with a low rebleeding \[10% in the EBL group and 13.33% in the EIS group\] and recurrence \[20% in the EBL group and 20% in the EIS group\] rates; also, EBL had significantly less pain and higher patient satisfaction than EIS. However, these authors have used liquid sclerosing agents (either ethanolamine oleate 5% or N-butyl cyanoacrylate). A recent portuguese study by Fernandes et al has evaluated the efficacy and safety of a sclerosing agent, polidocanol, foam injection in 2000 consecutive patients with prolapsed hemorrhoids (grades II/III/IV). This technique showed high efficacy (98%) and tolerability (92% with mild/no pain) with only 0,7% of serious complications (major bleeding n=3; urinary retention n=4; infection/suppuration requiring surgery n=2). Also, in this cohort, 210 patients (10,5%) were under anticoagulation or double antiplatelet therapy) and only 2 of these patients presented clinically significant bleeding. The authors conclude that polidocanol foam should be used as first-line treatment of most hemorrhoid patient, including those under anticoagulation and antiplatelet therapy. Nevertheless, no cirrhotic patients were included, so results cannot be generalized to this particular high-risk group.

The objective of this study is to prospectively evaluate the efficacy and safety of treatment of grade I, II and III internal hemorrhoidal disease with polidocanol foam in cirrhotic patients.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Therapeutic success
timeFrame: 9 weeks
measure: Incidence of Treatment Adverse Events
timeFrame: 9 weeks
Secondary outcomes:
measure: Variation of Goligher classification (hemorrhoidal prolapse from grade 1 to grade 4)
timeFrame: 9 weeks
measure: Number of office-based therapy sessions
timeFrame: 9 weeks
measure: Hemorrhoidal disease recurrence
timeFrame: 1 year
Other outcomes:
Locations:
city: Porto
country: Portugal
facility: Centro Hospitalar Universitário do Porto
Study officials:
affiliation: Centro Hospitalar Universitário de Santo António
name: Paulo Salgueiro, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
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