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Parenchyma Resection of Cirrhotic Liver by the Clamp Crushing Technique and the Ultrasonic Dissector (SECCI)

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ClinicalTrials.gov Identifier: NCT00763776
Recruitment Status : Terminated (difficulty for the patient recruiting)
First Posted : October 1, 2008
Last Update Posted : February 27, 2014
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:

To identify the most efficient parenchyma transection technique for cirrhotic liver resection between the clamp crushing technique and the ultrasonic dissector.

Primary endpoint is intra-operative blood loss during liver transection (ml). Expected results and implications: If one of the technique is better than the other, surgical teams could prefer it to minimize the morbidity of liver resection in cirrhotic patients.


Condition or disease Intervention/treatment Phase
Liver Cirrhosis Liver Neoplasms Carcinoma, Hepatocellular Device: clamp crushing technique Device: ultrasonic dissector Not Applicable

Detailed Description:

Design Multicentric randomized controlled simple blinded trial comparing the clamp crushing technique vs. the ultrasonic dissector. The trial will last 24 months with 21 month-inclusion time.

Patients Patients will be enrolled in 5 university hospitals in Ile de France. Eligibility criteria include adults with Child A liver cirrhosis undergoing partial hepatectomy (≥ 1 liver segment). Exclusion criteria include non cirrhotic patients, Child B or C cirrhosis, portal hypertension and laparoscopic hepatectomy.

Sample size calculation was performed with the expectation of a 250 ml (one red cells pack) difference in blood loss during parenchyma transection with a level of statistical significance of 0.05 and a power of 0.80. These calculations indicated to include at least 60 patients in each group.

Secondary endpoints include blood loss standardized to the transection area (ml/cm²), free margins around the tumor, postoperative liver ischemia-reperfusion injury and postoperative complications.

Course of the study An informed consent will be obtained from each patient prior to surgery. Each patient will be randomized the day prior to surgery. As usual, each patient will be followed daily until he will discharge (10 days) and for 2 months at the postoperative outcome patient clinic, which will end the study period for the patient.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Parenchyma Resection of Cirrhotic Liver by the Clamp Crushing Technique and the Ultrasonic Dissector : Randomized Comparative Study.
Study Start Date : July 2008
Actual Primary Completion Date : August 2010
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
1
Liver transection by clamp crushing technique
Device: clamp crushing technique
Liver transection during hepatectomy by clamp crushing technique

2
Liver transection by the ultrasonic dissector
Device: ultrasonic dissector
Liver transection during hepatectomy by the ultrasonic dissector




Primary Outcome Measures :
  1. Intra-operative blood loss during liver transection (ml). [ Time Frame: during liver transection ]

Secondary Outcome Measures :
  1. Intra-operative blood loss standardized to the transection area (ml/cm²) [ Time Frame: during liver transection ]
  2. free margins around the tumor [ Time Frame: during liver transection ]
  3. postoperative liver ischemia-reperfusion injury (post-operative peak of transaminases) [ Time Frame: daily until the discharge of the patient ]
  4. 60-day postoperative complications [ Time Frame: 2 months after the liver transection ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Child A liver cirrhosis
  • Partial hepatectomy (≥ 1 segment).
  • Patient at least 18 years of age

Exclusion Criteria:

  • Non cirrhotic patient
  • Child B or C cirrhosis
  • Portal hypertension
  • Laparoscopic hepatectomy.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00763776


Locations
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France
Hôpital BEAUJON
Clichy, France, 92 118
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Mickael LESURTEL, MD-PhD Assistance Publique - Hôpitaux de Paris
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00763776    
Other Study ID Numbers: K070105
First Posted: October 1, 2008    Key Record Dates
Last Update Posted: February 27, 2014
Last Verified: January 2011
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Liver cirrhosis
Hepatectomy
Liver parenchyma transection
Randomized controlled trial
Additional relevant MeSH terms:
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Carcinoma, Hepatocellular
Liver Neoplasms
Liver Cirrhosis
Fibrosis
Pathologic Processes
Liver Diseases
Digestive System Diseases
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site