CompletedNot Applicable

Endobiliary RFA for Unresectable Malignant Biliary Strictures

China174 participantsStarted 2013-05

Plain-language summary

Only a small proportion of patients with cholangiocarcinoma or ampullary carcinoma are suitable for surgical resection. The endoscopic or percutaneous transhepatic biliary drainage is accepted approaches for the relief of jaundice in malignant biliary obstruction. But restoration of bile flow have few improvement of the survival of cancer patient. By using endobiliary radiofrequency energy to destruct the tumorous tissue may delay tumour growth, which might improve the survival of patients. The feasibility and safety of this technique using HabibTM EndoHBP probe has been evident. The aims of this randomised, controlled, multicentre study is to evaluate whether endobiliary radiofrequency ablation(RFA) can improve the median survival of patients with unresectable biliary malignancy.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Either gender greater than or equal to 18 years of age. * Cholangiocarcinoma or ampullary cancer unsuitable for surgical resection by staging, comorbidities or patient wishes. Criteria of unresectability being based on 1) metastatic disease or 2) locally advanced. * Biliary obstruction, Bilirubin \> 40umol/L at diagnosis * Subjects capable of giving informed consent * Life expectancy of at least 3 months * Histologically (preferred) or radiologically confirmed cholangiocarcinoma or ampullary cancer Exclusion Criteria: * Cardiac Pacemaker * Patient unstable for endoscopy * Inability to give informed consent * Coagulopathy (INR \> 2.0 or PTT \> 100 sec or platelet count \< 50,000) * Performance status ECOG ≥3 (confined to bed / chair \> 50% waking hours) * Active suppurative cholangitis * Complex stenoses will not be eligible for the trial * Patients without access to duodenum or ampulla are not candidates for ERCP and stenting * Malignant ascites * Presence of main portal vein thrombosis * Prior stents placement * Prior Billroth II or roux-en Y reconstruction * Inability to insert a guide wire across the malignant stricture * Pregnancy * Presence of other malignancy * Life expectancy \< 3months

What they're measuring

Overall survival

Timeframe: 2 years

Trial details

NCT IDNCT01844245

SponsorBing Hu

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-12