Trial document




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  DRKS00010427

Trial Description

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Title

Randomized controlled trial on Pringle Maneuver to reduce blood loss during Stapler Hepatectomy - PriMal StHep

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Trial Acronym

PriMal StHep

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URL of the Trial

[---]*

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Brief Summary in Lay Language

The trial is supposed to find out if the temporary interruption of blood flow to the liver during partial liver resection can lower the blood loss. The interruption of blood flow to the liver is a well known procedure that can be done safely if not exceeding 45 minutes in an otherwise healthy liver. Using stapler for the dissection of the liver tissue, the dissection time is below ten minutes. The trial aims to prove that interrrupting blood flow to the liver for such a limited time can be done safely and lowers the blood loss. Patients who undergo scheduled resection of one half of the liver can participate in the trial.

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Brief Summary in Scientific Language

The controlled, randomized trial evaluates the influence of the Pringle's maneuver on the intraoperative blood loss during hemihepatectomy with vascular staplers. Since the duration of parenchymal dissection applying this method is below ten minutes, the Pringle's maneuver is expected to have no negative impact. The two - armed trial compares the intraoperative blood loss during stapler hemihepatectomy with and without the application of the Pringle's maneuver.

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Organizational Data

  •   DRKS00010427
  •   2016/04/21
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  •   yes
  •   Approved
  •   S-193/2015, Ethik-Kommission I der Medizinischen Fakultät Heidelberg
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Secondary IDs

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Health Condition or Problem studied

  •   C22.0 -  Malignant neoplasm: Liver cell carcinoma
  •   C78.7 -  Secondary malignant neoplasm of liver and intrahepatic bile duct
  •   C22.1 -  Malignant neoplasm: Intrahepatic bile duct carcinoma
  •   C22.3 -  Malignant neoplasm: Angiosarcoma of liver
  •   C22.4 -  Malignant neoplasm: Other sarcomas of liver
  •   C22.2 -  Malignant neoplasm: Hepatoblastoma
  •   C22.7 -  Malignant neoplasm: Other specified carcinomas of liver
  •   C22.9 -  Malignant neoplasm: Liver, unspecified
  •   D13.4 -  Benign neoplasm: Liver
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Interventions/Observational Groups

  •   Depending on the planned procedure, an upper midline incision with or without right lateral extension (“reversed L – shape”) is performed in a regular dorsal position. After the hepatic lesion is confirmed to be treatable by resection, the liver is freed from its ligaments and mobilized. Liver resection is performed in the stapler technique as described elsewhere (Schemmer P, Friess H, Hinz U, Mehrabi A, Kraus TW, Z’graggen K, et al. Stapler hepatectomy is a safe dissection technique: analysis of 300 patients. World J Surg. 2006 Mar;30(3):419–30). In all cases the central venous pressure will be kept at 5 mmHg or below by the anaesthesiologists according to routine liver surgery standards.
  •   Depending on the planned procedure, an upper midline incision with or without right lateral extension (“reversed L – shape”) is performed in a regular dorsal position. After the hepatic lesion is confirmed to be treatable by resection, the liver is freed from its ligaments and mobilized. A silicon tube is placed around the hepatoduodenal ligament as a tourniquet and closed with the beginning of the parenchymal dissection until the dissection is completed (so called Pringle's maneuver). Liver resection is performed in the stapler technique as described elsewhere (Schemmer P, Friess H, Hinz U, Mehrabi A, Kraus TW, Z’graggen K, et al. Stapler hepatectomy is a safe dissection technique: analysis of 300 patients. World J Surg. 2006 Mar;30(3):419–30). In all cases the central venous pressure will be kept at 5 mmHg or below by the anaesthesiologists according to routine liver surgery standards.
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Total intraoperative Blood loss during Stapler Hemihepatectomy

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Secondary Outcome

•Intraoperative BL per resection plane size (ml/cm²)
•Intraoperative blood transfusion requirements
•Postoperative ALT levels day 1 and 3
•Postoperative total Bilirubin levels day 1 and 3
•Postoperative INR day 1 and 3
•Blood transfusion requirements within the first three postoperative days
•90 – days Mortality

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2016/06/02
  •   106
  •   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

1)Patients undergoing Hemihepatectomy
2)Age eighteen or older
3)written informed consent for participation in the trial

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Exclusion Criteria

1)Anatomical alterations rendering study treatment impossible
2)Situation post interventional or operative portal vein embolization or ligation
3)Simultaneous resection of other organs excluding the gall bladder and the common bile duct
4)Liver cirrhosis exceeding "Child Pugh A"

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Addresses

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    • Universitätsklinikum HeidelbergKlinik für Allgemein-, Viszeral- und Transplantationschirurgie
    • Im Neuenheimer Feld 110
    • 69120  Heidelberg
    • Germany
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    • Universitätsklinikum HeidelbergKlinik für Allgemein-, Viszeral- und Transplantationschirurgie
    • Mr.  Prof. Dr. med.  Peter  Schemmer 
    • Im Neuenheimer Feld 110
    • 69120  Heidelberg
    • Germany
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    • Universitätsklinikum HeidelbergKlinik für Allgemein-, Viszeral- und Transplantationschirurgie
    • Mr.  Prof. Dr. med.  Peter  Schemmer 
    • Im Neuenheimer Feld 110
    • 69120  Heidelberg
    • Germany
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Sources of Monetary or Material Support

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    • Heidelberger Stiftung Chirurgie
    • Im Neuenheimer Feld 110
    • 69120  Heidelberg
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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