AzTrials
AzTrials

Primary Liver CarcinomaNCT02014025

Laparoscopic Hepatectomy Versus Open Hepatectomy for PHC

A study testing Open hepatectomy and Laparoscope hepatectomy in people with Primary Liver Carcinoma, run by Shuguo Zheng, MD at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Primary Liver Carcinoma
What is being tested?
Open hepatectomy and Laparoscope hepatectomy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
335 participants
Where
1 siteChina
Study dates
Mar 2013to May 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Inclusion criteria for the Laparoscope hepatectomy group are:
  • both male and female, aged 18 to 70;
  • PHC diagnosis is clear preoperative;
  • No active hepatitis and decompensated cirrhosis
  • 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;
  • no rupture or bleeding of the tumor;
Show all 12Show fewer
  • Child-Pugh class A or B liver function;
  • 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;
  • 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.
  • General condition of patients and cardiopulmonary function enough to tolerate surgery
  • voluntary participation in the study, and informed consent.
  • meet the criteria for Laparoscope hepatectomy group;

Who cannot join

  • (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

Trial locations and contacts

1 site in 1 country.

China1 site

  • Southwest Hospital

    Chongqing, Chongqing Municipality, 400038

Other trials in China

About this study

Official title: Laparoscopic Hepatectomy Versus Open Hepatectomy for PHC With a Tumor Size of 5-10cm:a Prospective Case-control Study

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㎝.

Read the detailed description

Background:primary hepatic carcinoma( PHC) is the world's most common and one of the most malignant tumors, the incidence of malignant tumors in the top five in the world, second only to mortality in gastric cancer, ranked No. 3. surgery and comprehensive treatment is recognized by the medical profession Surgical approach, surgical methods include open and laparoscopic liver resection .The safety and efficacy of laparoscopic resection small PHC has been recognized, but the safety and efficacy of laparoscopy PHC resection is still a dispute, that with a tumor size of 5～10㎝, the clinical evidence is a C or D grade level from the standard definition of evidence-based medicine literature which has been published , for laparoscopic liver resection versus open liver resection for these hepatocellular carcinoma prospective case-control study has not been reported.

Intervention:We will let the 90 patients who meet the inclusion criteria .Patients in hepatobiliary surgery A, D district is undergo traditional open liver resection, hepatobiliary surgery E district is undergo laparoscopic liver resection. In addition to the surgery way is different, the rest treatments are same.

Results:

  1. Clinical data include:operation time, intraoperative blood loss, volume of blood transfusion, Rate of blood transfusion, complications and mortality, postoperative liver function, resection margin, long-term curative effect and survival time were collected and analysed.
  2. Statistical method:groups t-test ，univariate/multivariate analysis, logistic regression analysis, mixed linear regression, Cox survival analysis ，Kaplan-Meier survival analysis，Log-rank curves were used.
Being tested
Open hepatectomy, Laparoscope hepatectomy
Keywords
Laparoscope hepatectomy, Open hepatectomy, large PHC, safety and sensibility
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Open hepatectomyProcedure or surgery

    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.

  • Laparoscope hepatectomyProcedure or surgery

    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.

Study groups in NCT02014025
Study groupRoleWhat they receive
laparoscope hepatectomyExperimentalWe 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.
Receives: Procedure: Laparoscope hepatectomy
open hepatectomyExperimentalWe 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.
Receives: Procedure: Open hepatectomy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. survival rate

    follow-up after the surgery every 3months, to understand relapse, death, statistics 1-year, 3-year overall survival rates，disease-free survival rates , recurrence and metastasis rate.

    Measured: 3-year

Secondary outcomes (1)

  1. intraoperative parameters

    operation time, intraoperative blood loss, rate of blood transfusion, tumor resection margin.

    Measured: during the operation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Dec 2013 (estimated)
  2. Study startMar 2013
  3. Primary completionMay 2015
  4. Study completionMay 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
335 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02014025
Sponsor's protocol ID
SWHZSG004
Other IDs
Zhengshuguo
Status last verified
Aug 2015
First submitted
8 Dec 2013
Last updated
11 Aug 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • Parkin 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.

    PubMed 15761078

  • Zhou 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.

    PubMed 12898232

  • Jingli 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.

    PubMed 17024537

  • Fu 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.

    PubMed 18326907

  • Agostini 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.

    PubMed 11928042

  • Metzelder 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.

    PubMed 18493892

  • Yin 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.

    PubMed 23099728

  • Rao A, Rao G, Ahmed I. Laparoscopic vs. open liver resection for malignant liver disease. A systematic review. Surgeon. 2012 Aug;10(4):194-201. doi: 10.1016/j.surge.2011.06.007. Epub 2011 Jul 30.

    PubMed 22818276

  • Toyosaka A, Okamoto E, Mitsunobu M, Oriyama T, Nakao N, Miura K. Intrahepatic metastases in hepatocellular carcinoma: evidence for spread via the portal vein as an efferent vessel. Am J Gastroenterol. 1996 Aug;91(8):1610-5.

    PubMed 8759671

  • Poon RT, Fan ST, Lo CM, Ng IO, Liu CL, Lam CM, Wong J. Improving survival results after resection of hepatocellular carcinoma: a prospective study of 377 patients over 10 years. Ann Surg. 2001 Jul;234(1):63-70. doi: 10.1097/00000658-200107000-00010.

    PubMed 11420484

  • Zhou XD. Recurrence and metastasis of hepatocellular carcinoma: progress and prospects. Hepatobiliary Pancreat Dis Int. 2002 Feb;1(1):35-41.

    PubMed 14607620

  • Hanazaki K, Kajikawa S, Shimozawa N, Matsushita A, Machida T, Shimada K, Yazawa K, Koide N, Adachi W, Amano J. Perioperative blood transfusion and survival following curative hepatic resection for hepatocellular carcinoma. Hepatogastroenterology. 2005 Mar-Apr;52(62):524-9.

    PubMed 15816471

  • Yeh CN, Lee WC, Jeng LB, Chen MF. Hepatic resection for hepatocellular carcinoma in Taiwan. Eur J Surg Oncol. 2002 Sep;28(6):652-6. doi: 10.1053/ejso.2002.1292.

    PubMed 12359203

  • Makino Y, Yamanoi A, Kimoto T, El-Assal ON, Kohno H, Nagasue N. The influence of perioperative blood transfusion on intrahepatic recurrence after curative resection of hepatocellular carcinoma. Am J Gastroenterol. 2000 May;95(5):1294-300. doi: 10.1111/j.1572-0241.2000.02028.x.

    PubMed 10811342

  • Kwon AH, Matsui Y, Kamiyama Y. Perioperative blood transfusion in hepatocellular carcinomas: influence of immunologic profile and recurrence free survival. Cancer. 2001 Feb 15;91(4):771-8.

    PubMed 11241245

Questions about this trial

What is this clinical trial studying?

A study testing Open hepatectomy and Laparoscope hepatectomy in people with Primary Liver Carcinoma, run by Shuguo Zheng, MD at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

survival rate (time frame: 3-year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02014025, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2015.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in