A Trial to Compare Pringle Maneuver With Either Infrahepatic Inferior Vena Cava Clamping or Low Central Venous Pressure
Recruitment status was Recruiting
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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.
| 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 |
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) |
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| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
During the study period, all patients who received liver resections were considered to be included into this study.
Inclusion Criteria:
- 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.
Exclusion Criteria:
- extrahepatic metastases in patients with malignancy;
- patients who refused to take part in this study.
Contacts and Locations| Contact: Xiaoping Chen, doctor | 8602783662851 ext 430030 | chenxp@medmail.com.cn |
| China, Hubei | |
| Hepatic surgery center, Tong ji Hospital | Recruiting |
| Wuhan, Hubei, China, 430030 | |
| Contact: Xiaoping Chen, Doctor 8602783662851 chenxp@medmail.com.cn | |
| Principal Investigator: peng zhu, doctor | |
| Study Director: | Xiaoping Chen, Doctor | Hepatic Surgery Center, Tongji Hospital, Tongji Medical college, Huazhong University of Science and Technology, Wuhan, China |
More Information
No publications provided by Huazhong University of Science and Technology
Additional 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 May 23, 2013