Trial document




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  DRKS00013276

Trial Description

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Title

Microscopic Tumor Clearance after Liver Transplantation for Proximal Bile Duct Cancer

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Trial Acronym

pro-duct002

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URL of the Trial

[---]*

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Brief Summary in Lay Language

The perihilar cholangiocarcinoma, also known as central bile duct carcinoma or Klatskin's tumor, is a malignant tumor with a poor prognosis. Extended liver resection is currently the only potential curative therapy, but only for a small proportion of affected patients. In addition to a distant metastasis, there are several surgical-technical aspects that speak against a resection in curative intention. If resection is not possible, only chemotherapy in palliative intention is possible. There are several center reports and data from international registries that postulate a liver transplantation in early perihilar cholangiocarcinomas without lymph node metastases as a possible curative treatment option. However, the evidence of the data available so far is insufficient to offer liver transplantation as a curative treatment option for patients. In this respect, prospective studies for the evaluation of important aspects of liver transplantation in perihilar cholangiocarcinomas are urgently needed.
The main objective of this clinical trial is to investigate liver transplantation for the rate of microscopically complete removal (R0) of a proximal bile duct carcinoma.
The study evaluates patients with non-resectable perihilar cholangiocarcinoma (Bismuth-Corlette type III / IV) for liver transplantation. Eligible patients will receive a liver transplantation within strict criteria (either from deceased or live donors).
Following liver transplantation, 4-weekly visits until month 3 are carried out as part of follow-up visits. Thereafter, the visits take place every 3 months until 2 years after transplantation. The aftercare does not deviate from the routine liver transplantation for primary liver carcinomas.

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Brief Summary in Scientific Language

A prospective, multicenter, non-randomized, open-label, one-arm study evaluating patients with non-resectable perihilar cholangiocarcinoma (Bismuth-Corlette type III / IV) for liver transplantation.
This study was designed as a prospective pilot study to collect data on the oncologic status of liver transplantation for patients with perihilar cholangiocarcinoma.

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Organizational Data

  •   DRKS00013276
  •   2018/01/05
  •   [---]*
  •   yes
  •   Approved
  •   EA2/191/17, Ethik-Kommission der Charité -Universitätsmedizin Berlin-
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   C24.0 -  Malignant neoplasm: Extrahepatic bile duct
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Interventions/Observational Groups

  •   Liver transplantation
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   II
  •   N/A
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Primary Outcome

Rate of microscopic tumor clearance (R0) after liver transplantation.
The freedom from tumors is documented in the pathological report, which is usually available no later than 7 days after transplantation.

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Secondary Outcome

• Overall survival after 36 months
• Recurrence-free survival after 36 months
• Postoperative complication rate (III - V according to Dindo-Clavien)

As part of the aftercare, there are 4-weekly visits until month 3 and then every 3 months until 2 years after transplantation.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
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Recruitment

  •   Actual
  •   2018/12/17
  •   50
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   70   Years
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Additional Inclusion Criteria

• Protocol defined diagnosis of perihilarcholangiocarcinoma in patients with primary sclerosing cholangitis (PSC): i.e. histological diagnosis of cholangiocarcinoma (obtained via ERC) or dominant stenosis plus cytological diagnosis of severe dysplasia or two subsequent cytological results of severe dysplasia or carcinoma whereby the second has been obtained after 2 weeks of antibiotic treatment to exclude inflammatory changes
• Protocol defined diagnosis of perihilar cholangiocarcinoma in patients without PSC: clinical diagnosis of proximal bile duct cancer based on ERC plus a second method (CT or MRI), cytology is obtained during ERC, but a cytological result of carcinoma or severe dysplasia is not mandatory
• tumor not curatively resectable as judged by an experienced hepatobiliary surgeon (> 50 liver resections for perihilar cholangiocarcinoma)
• on-line review of defined patient data and acceptance for priority listing by an Eurotransplant expert panel consisting of two experts recruited from the Eurotransplant Liver Allocation Committee; in case of split decision addition of a third expert for definite decision on priority listing with a respective matchMELD.
• obligatory staging laparotomy before priority listing (see SOP staging laparotomy, chapter 7.5.1.4)
• age between 18 and 70 years
• negative pregnancy test
• informed consent before study enrolment (all other procedures are clinical routine procedures in the management of these patients)

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Exclusion Criteria

• locally very advanced, unresectable tumor infiltrating adjacent other organs, the main trunk of the hepatic artery
• a visible tumor mass on CT or MRI scan larger than 3 cm in diameter
• highly elevated CA 19-9 levels (> 1000 U/ml)
• Decompression of the bile ducts by external drainage (PTCD)
• tumors suspicious for gallbladder cancer
• known lymph node or distant metastasis (determined mandatory by CT scan/MRI and laparotomy, further investigations if deemed necessary, a PET scan is recommended)
• patients undergoing multi-organ transplantation or have undergone previous solid organ or bone marrow transplantation
• previous photodynamic therapy, radiation, brachytherapy or combinations of these procedures
• previous tumor biopsy (except via ERC) systematic lymphadenectomy (except SOP defined staging laparotomy), surgical preparation at the region of the hepatoduodenal ligament (except cholecystectomy for other reasons) or previous completed or attempted surgery for hilar cholangiocarcinoma
• pregnancy or breastfeeding
• patients unwilling to consent to saving and propagation of pseudonymized medical data for study reasons
• general contraindications for liver transplantation
• subjects who are legally detained in an official institute

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Addresses

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    • Charité - Universitätsmedizin Berlin, Chirurgische Klinik, Campus Charité Mitte | Charité Campus Virchow-Klinikum
    • Mr.  Univ.-Prof. Dr. med.   Johann  Pratschke 
    • Augustenburger Platz 1
    • 13353  Berlin
    • Germany
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    • Charité - Universitätsmedizin Berlin, Chirurgische Klinik, Campus Charité Mitte | Campus Virchow-Klinikum
    • Mr.  Priv.-Doz. Dr. med.   Moritz  Schmelzle 
    • Augustenburger Platz 1
    • 13353  Berlin
    • Germany
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    • Charité - Universitätsmedizin Berlin, Chirurgische Klinik, Campus Charité Mitte | Campus Virchow-Klinikum
    • Ms.  Andrea  Köpke 
    • Augustenburger Platz 1
    • 13353  Berlin
    • Germany
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Sources of Monetary or Material Support

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    • Charité Campus Virchow-Klinikum
    • Augustenburger Platz 1
    • 13353  Berlin
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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