Clinical trial NCT01355887: A Trial to Compare Pringle Maneuver With Either Infrahepatic Inferior Vena Cava Clamping or Low Central Venous Pressure
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Liver Resection
Keywords: blood loss
hepatectomy
prospective study
PTC
Lead sponsor: Huazhong University of Science and Technology
Sponsor class: OTHER
Collaborators: name: Chinese University of Hong Kong
First posted: 2011-05-18
Enrollment: 192
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: During the study period, all patients who received liver resections were considered to be included into this study.

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.

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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Hepatic surgery center, Tong ji Hospital
state: Hubei
Study officials:
affiliation: Hepatic Surgery Center, Tongji Hospital, Tongji Medical college, Huazhong University of Science and Technology, Wuhan, China
name: Xiaoping Chen, Doctor
role: STUDY_DIRECTOR
References:
citation: 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.