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A Trial to Compare Pringle Maneuver With Either Infrahepatic Inferior Vena Cava Clamping or Low Central Venous Pressure

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2008 by Huazhong University of Science and Technology.
Recruitment status was:  Recruiting
Sponsor:
Collaborator:
Chinese University of Hong Kong
Information provided by:
Huazhong University of Science and Technology
ClinicalTrials.gov Identifier:
NCT01355887
First received: May 16, 2011
Last updated: May 17, 2011
Last verified: January 2008
  Purpose
The purpose of this study is to better comprehend the benefits and efficacy of portal triad clamping with infrahepatic IVC clamping during complex hepatectomy. A randomized comparative trial was performed to compare PTC(pringle triad clamping) with either infrahepatic IVC clamping or low central venous pressure in complex liver resections.

Condition Phase
Liver Resection
Phase 3

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Prospective Randomized Comparative Trial to Compare Pringle Maneuver With Either Infrahepatic Inferior Vena Cava Clamping or Low Central Venous Pressure in Complex Liver Resections

Further study details as provided by Huazhong University of Science and Technology:

Biospecimen Description:
No biospecimens

Estimated Enrollment: 192
Study Start Date: January 2008
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Detailed Description:
To better comprehend the benefits and efficacy of portal triad clamping with infrahepatic IVC clamping during complex hepatectomy. A randomized comparative trial was performed to compare PTC with either infrahepatic IVC clamping or low central venous pressure in complex liver resections. 192 consecutive patients were involved in this study and allocated equally to two groups. Preoperative demographic and clinical data, details of surgical procedure, pathologic diagnosis, postoperative course and complications were collected prospectively.
  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
During the study period, all patients who received liver resections were considered to be included into this study.
Criteria

Inclusion Criteria:

  1. patients who were assessed by preoperative medical imagings to have a high risk of backflow bleeding from the major hepatic veins and the IVC, based on the size and location of the tumor. The tumors were ≥5 cm in diameter and they involved the liver segments 7, 8 and/or the cranial portion of segment 4. These tumors were in close proximity or were compressing, but had not actually invaded, the major hepatic veins or IVC
  2. Pugh-Child Grade A
  3. Indocyanine green retention rate at 15 minutes (ICGR15) < 10%;
  4. acceptable clotting profile (platelet count ≥ 50 ×109/L and prothrombin activity ≥ 60%)
  5. no previous liver resection.

Exclusion Criteria:

  1. extrahepatic metastases in patients with malignancy;
  2. patients who refused to take part in this study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01355887

Locations
China, Hubei
Hepatic surgery center, Tong ji Hospital
Wuhan, Hubei, China, 430030
Sponsors and Collaborators
Huazhong University of Science and Technology
Chinese University of Hong Kong
Investigators
Study Director: Xiaoping Chen, Doctor Hepatic Surgery Center, Tongji Hospital, Tongji Medical college, Huazhong University of Science and Technology, Wuhan, China
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Chen Xiaoping, Hepatic Surgery Center, Tongji Hospital, Tongji Medical college, Huazhong University of Science and Technology, Wuhan, China
ClinicalTrials.gov Identifier: NCT01355887     History of Changes
Other Study ID Numbers: CHENXP003 
Study First Received: May 16, 2011
Last Updated: May 17, 2011
Health Authority: China: Ministry of Health

Keywords provided by Huazhong University of Science and Technology:
blood loss
hepatectomy
prospective study
PTC

ClinicalTrials.gov processed this record on December 02, 2016