Trial document




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  DRKS00019002

Trial Description

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Title

ALPPS versus two stage hepatectomy in colorectal liver metastases

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Trial Acronym

ALPPS vs. TSH in CRLM

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Bowel cancer is one of the most common tumors worldwide. Long-term survival in patients with bowel cancer is dependent on the presence of metastases and the associated treatment. This study investigates the influence of two distinct liver operations on survival in case of liver metastases due to bowel cancer.

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Brief Summary in Scientific Language

Colorectal cancer is one of the leading causes of tumor-related mortality worldwide with liver metastases (CRLM) being the most common form of distant metastases. Liver surgery emerged as the mainstay of the curative therapy since it provides excellent oncologic outcome compared to palliative therapies. However, only 15% – 30% of all patients with CRLM are referred to surgical treatment due to large hepatic tumor burden and/or the presence of multiple extrahepatic metastases. Novel surgical procedures such as two-staged hepatectomies combined with inter-stage portal vein embolization (TSH/PVE) and associating liver partition and portal vein ligation for staged hepatectomy (ALPPS) have been introduced to increase resectability rates in recent years. This study aims to evaluate the technical feasibility of ALPPS and TSH/PVE and compare the oncologic outcomes of these novel and complex procedures in patients with CRLM.


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Organizational Data

  •   DRKS00019002
  •   2019/11/04
  •   [---]*
  •   yes
  •   No approval required according to EC
  •   EK 341/19, Ethik-Kommission an der Medizinischen Fakultät der RWTH Aachen
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Secondary IDs

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

  •   C78.7 -  Secondary malignant neoplasm of liver and intrahepatic bile duct
  •   C18 -  Malignant neoplasm of colon
  •   C19 -  Malignant neoplasm of rectosigmoid junction
  •   C20 -  Malignant neoplasm of rectum
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Interventions/Observational Groups

  •   ALPPS
    (Surveillance from surgery to follow-up)
  •   TSH/PVE (Surveillance from surgery to follow-up)
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control (effective treament of control group)
  •   Treatment
  •   Other
  •   N/A
  •   No
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Primary Outcome

Overall survival after surgery

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Secondary Outcome

Recurrence-free survival after surgery; perioperative morbidity and mortality

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2019/10/27
  •   53
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

All patients undergoing either ALPPS or TSH/PVE for colorectal liver metastases

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Exclusion Criteria

Intraoperativ change in strategy

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Addresses

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    • Universitätsklinikum der RWTH Aachen
    • Pauwelsstraße 30
    • 52074  Aachen
    • Germany
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    • Universitätsklinikum der RWTH Aachen
    • Mr.  Dr. med.  Jan  Bednarsch 
    • Pauwelsstraße 30
    • 52074  Aachen
    • Germany
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    • Universitätsklinikum der RWTH Aachen
    • Mr.  Dr. med.  Jan  Bednarsch 
    • Pauwelsstraße 30
    • 52074  Aachen
    • Germany
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Sources of Monetary or Material Support

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    • START Programm RWTH Aachen
    • Templergraben 55
    • 52062  Aachen
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2019/10/28
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.