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

Organizational Data

DRKS-ID:
DRKS00010427
Recruitment Status:
Recruiting ongoing
Date of registration in DRKS:
2016-04-21
Last update in DRKS:
2017-07-28
Registration type:
Prospective

Acronym/abbreviation of the study

PriMal StHep

URL of the study

No Entry

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.

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.

Health condition or problem studied

ICD10:
C22.0 - Liver cell carcinoma
ICD10:
C78.7 - Secondary malignant neoplasm of liver and intrahepatic bile duct
ICD10:
C22.1 - Intrahepatic bile duct carcinoma
ICD10:
C22.3 - Angiosarcoma of liver
ICD10:
C22.4 - Other sarcomas of liver
ICD10:
C22.2 - Hepatoblastoma
ICD10:
C22.7 - Other specified carcinomas of liver
ICD10:
C22.9 - Liver, unspecified
ICD10:
D13.4 - Liver
Healthy volunteers:
No Entry

Interventions, Observational Groups

Arm 1:
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.
Arm 2:
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.

Endpoints

Primary outcome:
Total intraoperative Blood loss during Stapler Hemihepatectomy
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

Study Design

Purpose:
Treatment
Allocation:
Randomized controlled study
Control:
  • Active control (effective treatment of control group)
Phase:
N/A
Study type:
Interventional
Mechanism of allocation concealment:
No Entry
Blinding:
No
Assignment:
Parallel
Sequence generation:
No Entry
Who is blinded:
No Entry

Recruitment

Recruitment Status:
Recruiting ongoing
Reason if recruiting stopped or withdrawn:
No Entry

Recruitment Locations

Recruitment countries:
  • Germany
Number of study centers:
Monocenter study
Recruitment location(s):
  • University medical center Klinik für Allgemein-, Viszeral- und Transplantationschirurgie Heidelberg

Recruitment period and number of participants

Planned study start date:
2016-05-01
Actual study start date:
2016-06-02
Planned study completion date:
No Entry
Actual Study Completion Date:
No Entry
Target Sample Size:
106
Final Sample Size:
No Entry

Inclusion Criteria

Sex:
All
Minimum Age:
18 Years
Maximum Age:
no maximum age
Additional Inclusion Criteria:
1)Patients undergoing Hemihepatectomy 2)Age eighteen or older 3)written informed consent for participation in the trial

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"

Addresses

Primary Sponsor

Universitätsklinikum HeidelbergKlinik für Allgemein-, Viszeral- und Transplantationschirurgie
Im Neuenheimer Feld 110
69120 Heidelberg
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
No Entry
Investigator Sponsored/Initiated Trial (IST/IIT):
Yes

Contact for Scientific Queries

Universitätsklinikum HeidelbergKlinik für Allgemein-, Viszeral- und Transplantationschirurgie
Prof. Dr. med. Peter Schemmer
Im Neuenheimer Feld 110
69120 Heidelberg
Germany
Telephone:
06221566111
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Contact for Public Queries

Universitätsklinikum HeidelbergKlinik für Allgemein-, Viszeral- und Transplantationschirurgie
Prof. Dr. med. Peter Schemmer
Im Neuenheimer Feld 110
69120 Heidelberg
Germany
Telephone:
06221566111
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Principal Investigator

Universitätsklinikum HeidelbergKlinik für Allgemein-, Viszeral- und Transplantationschirurgie
Prof. Dr. med. Peter Schemmer
Im Neuenheimer Feld 110
69120 Heidelberg
Germany
Telephone:
06221566111
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Sources of Monetary or Material Support

Private sponsorship (foundations, study societies, etc.)

Heidelberger Stiftung Chirurgie
Im Neuenheimer Feld 110
69120 Heidelberg
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Ethics Committee

Address Ethics Committee

Ethikkommission der Medizinischen Fakultät Heidelberg
Alte Glockengießerei 11/1
69115 Heidelberg
Germany
Telephone:
+49-6221-338220
Fax:
+49-6221-3382222
Contact per E-Mail
URL:
No Entry

Vote of leading Ethics Committee

Date of ethics committee application:
2015-02-11
Ethics committee number:
S-193/2015
Vote of the Ethics Committee:
Approved
Date of the vote:
2015-05-18

Further identification numbers

Other primary registry ID:
No Entry
EudraCT Number:
No Entry
UTN (Universal Trial Number):
No Entry
EUDAMED Number:
No Entry

IPD - Individual Participant Data

Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
No Entry
IPD Sharing Plan:
No Entry

Study protocol and other study documents

Study protocols:
No Entry
Study abstract:
No Entry
Other study documents:
No Entry
Background literature:
No Entry
Related DRKS studies:
No Entry

Publication of study results

Planned publication:
No Entry
Publikationen/Studienergebnisse:
No Entry
Date of first publication of study results:
No Entry
DRKS entry published for the first time with results:
No Entry

Basic reporting

Basic Reporting / Results tables:
No Entry
Brief summary of results:
No Entry