Clinical trial · Interventional
Phlebotomy and Risk of Hepatocellular Carcinoma in Patients With Compensated Alcoholic Cirrhosis
Influence of Iron Depletion by Phlebotomy on the Risk of Hepatocellular Carcinoma Occurrence in Patients With Compensated Alcoholic Cirrhosis. Prospective, Multicentre, Randomized Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): delayed recruitment as compared to that expected
Summary
Brief summary (as posted)
The main objective of the study is to assess in patients with compensated alcoholic cirrhosis and hepatic iron overload (HIO), as assessed by MRI, the effect of phlebotomy in order to lower and maintain serum ferritin below 50 µg / l on the risk of hepatocellular carcinoma (HCC) occurrence. The effect of bloodletting will be jointly evaluated on 1) episodes of hepatic decompensation, 2) non HCC liver-related mortality 3) changes in HIO during follow-up.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Alcoholic Cirrhosis | — | UNRESOLVED | — |
| Iron Overload | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| phlebotomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- phlebotomy
- interventionNames
- Procedure: phlebotomy
- type
- NO_INTERVENTION
- label
- control
Primary outcomes (1)
- measure
- Cumulative incidence of HepatoCellular Carcinoma during follow-up
- timeFrame
- 3 years
- description
- the cumulative incidence of HCC will be estimated considering death prior to the event of interest as competing risk outcomes
Secondary outcomes (3)
- measure
- Number of hepatic decompensation episodes in study participants
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age over 18 * Biopsy-proven alcoholic cirrhosis * No previous HCC (treated or not) * Excessive alcohol consumption, defined by more than 21 glasses weekly in women and more than 28 glasses weekly in men for at least 10 years, and considered as the main cause for liver cirrhosis * Signed written informed consent * Hepatic iron overload assessed by MRI (Iron hepatic concentration ≥ 80 μmol/g) Exclusion Criteria: * Subjects deprived of their liberty by judicial or administrative decision * Pregnant women * Serious associated short-term life threatening disease (except HIV viral co-infection, or the liver disease itself) * Impossibility of monitoring, whatever the reason. * Contraindication of phlebotomy * Haemoglobin \<13.5 g/dL for men and \<12.5g/dL for women (threshold established by the French Blood Agency) * Congestive heart failure or coronary heart disease * Hepatic failure (TP\<60%), renal failure (GFR \<50 ml/min) or respiratory insufficiency (chronic dyspnea) * Poor venous system * Complication of cirrhosis at time of inclusion (defined as bleeding related to portal hypertension, encephalopathy or ascites) * Presence of hepatitis B or hepatitis C co-infection * Presence of liver focal lesion suggestive of HCC * Child-Pugh score greater than or equal to 7 (Class B or C) at time of inclusion
References
Publications (0)
Data not yet available