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

Liver Resection Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01355887
• Other study ID #: CHENXP003
• Status: Recruiting
• Phase: Phase 3
• First received: May 16, 2011
• Last updated: May 17, 2011
• Start date: January 2008
• Est. completion date: December 2011

Study information

• Verified date: January 2008
• Source: Huazhong University of Science and Technology
• Contact: Xiaoping Chen, doctor
• Phone: 8602783662851
• Email: chenxp[@]medmail.com.cn
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 192
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Liver Resection

Locations

Country	Name	City	State
China	Hepatic surgery center, Tong ji Hospital	Wuhan	Hubei

Sponsors (2)

Lead Sponsor	Collaborator
Huazhong University of Science and Technology	Chinese University of Hong Kong

Country where clinical trial is conducted

China,