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

NCT01355887 | Unknown DMC

• 1 other identifier: CHENXP003
• Study Type: observational
• Target: 192
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Resection

Keywords

blood loss; hepatectomy; prospective study; PTC

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

During the study period, all patients who received liver resections were considered to be included into this study.

You may qualify if:

• 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
• Pugh-Child Grade A
• Indocyanine green retention rate at 15 minutes (ICGR15) \< 10%;
• acceptable clotting profile (platelet count ≥ 50 ×109/L and prothrombin activity ≥ 60%)
• no previous liver resection.

You may not qualify if:

• extrahepatic metastases in patients with malignancy;
• patients who refused to take part in this study.

Sponsors & Collaborators

• Huazhong University of Science and Technology: lead
• Chinese University of Hong Kong: collaborator

Study Sites (1)

Hepatic surgery center, Tong ji Hospital

Wuhan, Hubei, 430030, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 22389136 DERIVED

Biospecimen

No biospecimens

MeSH Terms

Conditions

Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Xiaoping Chen, Doctor

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

  STUDY DIRECTOR

Central Study Contacts

Xiaoping Chen, doctor

CONTACT

8602783662851; chenxp@medmail.com.cn

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 16, 2011
• First Posted: May 18, 2011
• Study Start: January 1, 2008
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: May 18, 2011

Record last verified: 2008-01

Locations

CN (1)