Clinical trial · Interventional
Laparoscopic Hepatectomy Versus Open Hepatectomy for PHC
Laparoscopic Hepatectomy Versus Open Hepatectomy for PHC With a Tumor Size of 5-10cm:a Prospective Case-control Study
NCT02014025CI-TRIAL-00018808completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to compare short-term and long-term efficacy of laparoscope hepatectomy and open hepatectomy, evaluate the safety and efficacy of laparoscope hepatectomy the PHC with a tumor size of 5~10㎝,and provide class B evidence based medicine for laparoscope hepatectomy for PHC with a tumor size of 5~10㎝.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Primary Liver Carcinoma | Liver Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Laparoscope hepatectomy | Procedure | — | UNRESOLVED |
| Open hepatectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- laparoscope hepatectomy
- description
- We let the 45 patients who are meet the inclusion criteria .Hospital in hepatobiliary surgery E district is Group B ,they will accept laparoscopic hepatectomy: tumors are totally resected through laparoscopic.
- interventionNames
- Procedure: Laparoscope hepatectomy
- type
- EXPERIMENTAL
- label
- open hepatectomy
- description
- We let the 45 patients who are meet the inclusion criteria .Hospital in hepatobiliary surgery A and D district is Group A ,they will accept Open Hepatectomy: tumors are totally resected by conventional laparotomy.
- interventionNames
- Procedure: Open hepatectomy
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Inclusion criteria for the Laparoscope hepatectomy group are: 1. both male and female, aged 18 to 70; 2. PHC diagnosis is clear preoperative; 3. No active hepatitis and decompensated cirrhosis 4. tumor size of 5-10 cm,no intrahepatic or distant metastasis,no tumor thrombus in the portal vein, hepatic vein, vena cava, or bile duct; and no invasion of the diaphragm or surrounding tissues; 5. no rupture or bleeding of the tumor; 6. Child-Pugh class A or B liver function; 7. indocyanine green retention rate at 15 min of \<15%, and a remnant liver volume/standard liver volume ratio of \>50% in patients with liver cirrhosis and \>35% in patients without liver cirrhosis; 8. upper abdominal surgery, radiofrequency ablation, Transhepatic Arterial Chemotherapy And Embolization treatment, radiotherapy and chemotherapy have not been implemented and no previous surgery that absolutely contraindicated Laparoscope hepatectomy. 9. General condition of patients and cardiopulmonary function enough to tolerate surgery 10. voluntary participation in the study, and informed consent. * Inclusion criteria for the Open hepatectomy group are: meet the criteria for Laparoscope hepatectomy group; Exclusion Criteria: * (1) age \<18 years or\> 70 years , pregnant or lactating women; (2) tumor size ≥10 cm, or tumor location that would interfere with intraoperative exposure and isolation of the hepatic hilum; (3) tumor encroaching on the hepatic hilum , the portal vein, primary bile duct or tumor adjacent to the major vascular structures ; (4) unable to tolerate a pneumoperitoneum or can't tolerate surgery duo to cardiopulmonary dysfunction; (5) severe upper abdominal adhesions; (6)Pathologically confirmed positive margins
References
Publications (15)
- BACKGROUNDParkin DM, Bray F, Ferlay J, Pisani P. Global cancer statistics, 2002. CA Cancer J Clin. 2005 Mar-Apr;55(2):74-108. doi: 10.3322/canjclin.55.2.74. PMID 15761078
- BACKGROUNDZhou XD, Tang ZY, Ma ZC, Wu ZQ, Fan J, Qin LX, Zhang BH. Surgery for large primary liver cancer more than 10 cm in diameter. J Cancer Res Clin Oncol. 2003 Sep;129(9):543-8. doi: 10.1007/s00432-003-0446-6. Epub 2003 Jul 30. PMID 12898232
- BACKGROUNDJingli C, Rong C, Rubai X. Influence of colorectal laparoscopic surgery on dissemination and seeding of tumor cells. Surg Endosc. 2006 Nov;20(11):1759-61. doi: 10.1007/s00464-005-0694-4. Epub 2006 Oct 5. PMID 17024537
- BACKGROUNDFu C, Li GY, Liu FY, Lin QH, Fang XL. [Effect of carbon dioxide pneumoperitoneum-laparoscopic surgery on tumor seeding and metastases in endometrial cancer]. Zhong Nan Da Xue Xue Bao Yi Xue Ban. 2008 Feb;33(2):130-7. Chinese. PMID 18326907
- BACKGROUNDAgostini A, Robin F, Jais JP, Aggerbeck M, Vilde F, Blanc B, Lecuru F. Impact of different gases and pneumoperitoneum pressures on tumor growth during laparoscopy in a rat model. Surg Endosc. 2002 Mar;16(3):529-32. doi: 10.1007/s004640090081. Epub 2001 Nov 16. PMID 11928042
- BACKGROUNDMetzelder M, Kuebler JF, Shimotakahara A, Chang DH, Vieten G, Ure B. CO2 pneumoperitoneum increases survival in mice with polymicrobial peritonitis. Eur J Pediatr Surg. 2008 Jun;18(3):171-5. doi: 10.1055/s-2008-1038365. PMID 18493892
- BACKGROUNDYin Z, Fan X, Ye H, Yin D, Wang J. Short- and long-term outcomes after laparoscopic and open hepatectomy for hepatocellular carcinoma: a global systematic review and meta-analysis. Ann Surg Oncol. 2013 Apr;20(4):1203-15. doi: 10.1245/s10434-012-2705-8. Epub 2012 Oct 26. PMID 23099728