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Effect of the pringle maneuver on tumor recurrence of hepatocellular carcinoma after curative resection (EPTRH): a randomized, prospective, controlled multicenter trial
- Source :
- BMC Cancer, BMC Cancer, Vol 12, Iss 1, p 340 (2012)
- Publication Year :
- 2012
- Publisher :
- BioMed Central, 2012.
-
Abstract
- Background Hepatic resection is currently still the best choice of therapeutic strategies for liver cancer, but the long-term survival rate after surgery is unsatisfactory. Most patients develop intra- and/or extrahepatic recurrence. The reasons for this high recurrence rate are not entirely clear. Recent studies have indicated that ischemia-reperfusion injury to the liver may be a significant factor promoting tumor recurrence and metastasis in animal models. If this is also true in humans, the effects of the Pringle maneuver, which has been widely used in hepatectomy for the past century, should be examined. To date, there are no reported data or randomized controlled studies examining the relationship between use of the Pringle maneuver and local tumor recurrence. We hypothesize that the long-term prognosis of patients with liver cancer could be worsened by use of the Pringle maneuver due to an increase in the rate of tumor recurrence in the liver remnant. We designed a multicenter, prospective, randomized surgical trial to test this hypothesis. Methods At least 498 eligible patients from five participating centers will be enrolled and randomized into either the Pringle group or the non-Pringle group in a ratio of 1:1 using a permuted-blocks randomization protocol. After the completion of surgical intervention, patients will be included in a 3-year follow-up program. Discussion This multicenter surgical trial will examine whether the Pringle maneuver has a negative effect on the long-term outcome of hepatocellular carcinoma patients. The trial will also provide information about prognostic differences, safety, advantages and disadvantages between Pringle and non-Pringle surgical procedures. Ultimately, the results will increase the available information about the effects of ischemia-reperfusion injury on tumor recurrence, which will be of immense benefit to general surgery. Trial registration http://www.clinicaltrials.gov NCT00725335
- Subjects :
- Cancer Research
medicine.medical_specialty
Carcinoma, Hepatocellular
Hepatocellular carcinoma
medicine.medical_treatment
Ischemia/reperfusion
lcsh:RC254-282
law.invention
Metastasis
Pringle maneuver
Study Protocol
Randomized controlled trial
law
Multicenter trial
Genetics
Carcinoma
Medicine
Hepatectomy
Humans
Survival rate
Randomized Controlled Trials as Topic
business.industry
Liver Neoplasms
medicine.disease
lcsh:Neoplasms. Tumors. Oncology. Including cancer and carcinogens
Surgery
Clinical trial
Oncology
Reperfusion Injury
Neoplasm Recurrence, Local
business
Liver cancer
Subjects
Details
- Language :
- English
- ISSN :
- 14712407
- Volume :
- 12
- Database :
- OpenAIRE
- Journal :
- BMC Cancer
- Accession number :
- edsair.doi.dedup.....50c79b14d3a43cbd12728dd7c9d1c918