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

NCT ID: NCT01355887

Last Updated: 2011-05-18

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 192 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2011-12-31

Brief 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.

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.

Conditions

Liver Resection

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Eligibility 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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese University of Hong Kong

OTHER

Sponsor Role: collaborator

Huazhong University of Science and Technology

OTHER

Sponsor Role: lead

Responsible Party

Hepatic Surgery Center, Tongji Hospital, Tongji Medical college, Huazhong University of Science and Technology, Wuhan, China

Principal Investigators

Xiaoping Chen, Doctor

Role: STUDY_DIRECTOR

Hepatic Surgery Center, Tongji Hospital, Tongji Medical college, Huazhong University of Science and Technology, Wuhan, China

Locations

Hepatic surgery center, Tong ji Hospital

Wuhan, Hubei, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xiaoping Chen, doctor

Role: CONTACT

chenxp@medmail.com.cn

8602783662851 ext. 430030

Facility Contacts

Xiaoping Chen, Doctor

Role: primary

chenxp@medmail.com.cn

8602783662851

References

Zhu P, Lau WY, Chen YF, Zhang BX, Huang ZY, Zhang ZW, Zhang W, Dou L, Chen XP. Randomized clinical trial comparing infrahepatic inferior vena cava clamping with low central venous pressure in complex liver resections involving the Pringle manoeuvre. Br J Surg. 2012 Jun;99(6):781-8. doi: 10.1002/bjs.8714. Epub 2012 Mar 2.

Reference Type: DERIVED

PMID: 22389136 (View on PubMed)

Other Identifiers

CHENXP003

Identifier Type: -

Identifier Source: org_study_id