Hepatocellular CarcinomaNCT00725335
Effect of I/R Injuries by Pringle Manoeuvre on the Prognosis of HCC Patients After Curative Hepatectomy
A study testing curative resection without Pringle and curative resection with Pringle manoeuvre in people with Hepatocellular Carcinoma, run by Southwest Hospital, China at 1 site in China.
Trial summary
This is a multi-centre prospective randomized controlled trial to explore the influence of ischemia-reperfusion injuries elicited by pringle manoeuvre during radical excision on the prognosis of Hepatocellular Carcinoma (HCC) patients. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- curative resection without Pringle and curative resection with Pringle manoeuvre
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 498 participants
- Where
- 1 siteChina
- Study dates
- Sep 2008to Nov 2012
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of resectable primary liver cancer
- The liver function showed:Child-Pugh A，ICG-R15 < 20%
- HbsAg (+)
- tumor nodes in the liver were singular or multiple and could be radical excision
- No preoperative anti-cancer therapy
- Written informed consent from the patient or legal guardian prior to entering the study
Who cannot join
- Pregnancy patients
- With extrahepatic tumor or lymphnode metastasis
- Tumor invasion or thrombosis in portal vein,hepatic vein or inferior vena cava
- Positive marginal
Trial locations and contacts
1 site in 1 country.
China1 site
Institute of hepatobiliary surgery,southwest hospital
Chongqing, Chongqing Municipality, 400038
About this study
Official title: The Effect of Ischemia/Reperfusion Injuries Elicited by Pringle Manoeuvre on the Prognosis of HCC Patients After Curative Excision:A Multicenter Prospective Randomized Controlled Trial
This is a multi-centre prospective randomized controlled trial to explore the influence of ischemia-reperfusion injuries elicited by pringle manoeuvre during radical excision on the prognosis of Hepatocellular Carcinoma (HCC) patients.
Read the detailed description
Until now there are two popular procedures during the radical excision of primary liver cancer in our country.One is to give a pringle manoeuvre to control the operative blood loss,the other is using a combination of CUSA and Tissue-link to control the bleeding while without liver ischemia.According to the recent experimental studies in rats,we know that the ischemia and reperfusion injury may contribute to the metastasis of the tumor.In order to test the actual contribution of ischemia on human,we conduct this prospective clinical trial to compare the two popular procedures' effect on the prognosis of liver cancer patients undergoing radical excision.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- curative resection without Pringle, curative resection with Pringle manoeuvre
- Keywords
- ischemia, liver cancer, radical excision, prognosis
- Medical subject headings
- Carcinoma, Hepatocellular, Ischemia, Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
curative resection without PringleProcedure or surgery
Also called Experimental group
Radical excision of liver cancer without the procedure of pringle manoeuvre
curative resection with Pringle manoeuvreProcedure or surgery
Also called control group
curative resection liver cancer under pringle manoeuvre
| Study group | Role | What they receive |
|---|---|---|
| group A,non-pringle group | Experimental | Intervention of curative resection of HCC Without pringle manoeuvre in this arm Receives: Procedure: curative resection without Pringle |
| pringle group(B) | Active comparator | when the curative resection of HCC performed, the pringle manoeuvre will be routinely applied. Receives: Procedure: curative resection with Pringle manoeuvre |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease free survival
Measured: 1,3,5-year
Secondary outcomes (1)
overall survival,morbidity,postoperative mortality;blood loss,Liver function test,etc
Measured: baseline~2 weeks, 5-year overall survival
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2008 (estimated)
- Study startSep 2008
- Primary completionJun 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 498 participants (actual)
Sponsor and investigators
- Lead sponsor
- Southwest Hospital, China
- Sponsor type
- University, hospital or other
- Collaborators
- Chinese PLA General Hospital, Fudan University, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, First Affiliated Hospital, Sun Yat-Sen University
- Responsible party
- Principal investigator, feng xiaobin, Southwest Hospital, China
- Investigators
- Dong Jiahong, Ph D, Study director, Institue of hepatobiliary surgery,Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00725335
- Sponsor's protocol ID
- SWHB001
- Other IDs
- ISRCTN01960869
- Status last verified
- Nov 2012
- First submitted
- 24 Jul 2008
- Last updated
- 27 Nov 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Xiaobin F, Shuguo Z, Jian Z, Yudong Q, Lijian L, Kuansheng M, Xiaowu L, Feng X, Dong Y, Shuguang W, Ping B, Jiahong D. Effect of the pringle maneuver on tumor recurrence of hepatocellular carcinoma after curative resection (EPTRH): a randomized, prospective, controlled multicenter trial. BMC Cancer. 2012 Aug 3;12:340. doi: 10.1186/1471-2407-12-340.
PubMed 22862951
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Ischemia/Reperfusion Injuries Elicited by Pringle Manoeuvre on the Prognosis of HCC Patients After Curative Excision:A Multicenter Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00725335
- Acronym / sponsor ID
- SWHB001
- Conditions
- Hepatocellular Carcinoma
- Keywords
- ischemia, liver cancer, radical excision, prognosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 498 participants (actual)
- Lead sponsor
- Southwest Hospital, ChinaUniversity, hospital or other
- Collaborators
- Chinese PLA General Hospital, Fudan University, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, First Affiliated Hospital, Sun Yat-Sen University
- Study start
- Sep 2008
- Primary completion
- Jun 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 30 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multi-centre prospective randomized controlled trial to explore the influence of ischemia-reperfusion injuries elicited by pringle manoeuvre during radical excision on the prognosis of Hepatocellular Carcinoma (HCC) patients.
Detailed description
Until now there are two popular procedures during the radical excision of primary liver cancer in our country.One is to give a pringle manoeuvre to control the operative blood loss,the other is using a combination of CUSA and Tissue-link to control the bleeding while without liver ischemia.According to the recent experimental studies in rats,we know that the ischemia and reperfusion injury may contribute to the metastasis of the tumor.In order to test the actual contribution of ischemia on human,we conduct this prospective clinical trial to compare the two popular procedures' effect on the prognosis of liver cancer patients undergoing radical excision.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group A,non-pringle group | Experimental | Procedure: curative resection without PringleIntervention of curative resection of HCC Without pringle manoeuvre in this arm |
| pringle group(B) | Active comparator | Procedure: curative resection with Pringle manoeuvrewhen the curative resection of HCC performed, the pringle manoeuvre will be routinely applied. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Clinical diagnosis of resectable primary liver cancer
- The liver function showed:Child-Pugh A，ICG-R15 < 20%
- HbsAg (+)
- tumor nodes in the liver were singular or multiple and could be radical excision
- No preoperative anti-cancer therapy
Key exclusion criteria (4 listed)
- Pregnancy patients
- With extrahepatic tumor or lymphnode metastasis
- Tumor invasion or thrombosis in portal vein,hepatic vein or inferior vena cava
- Positive marginal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| curative resection without PringleAlso: Experimental groupRadical excision of liver cancer without the procedure of pringle manoeuvre | Procedure or surgery | group A,non-pringle group |
| curative resection with Pringle manoeuvreAlso: control groupcurative resection liver cancer under pringle manoeuvre | Procedure or surgery | pringle group(B) |
Primary outcome
Disease free survival
Time frame: 1,3,5-year
1 secondary outcome
overall survival,morbidity,postoperative mortality;blood loss,Liver function test,etc
Time frame: baseline~2 weeks, 5-year overall survival
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2012.
- Derived from this study: PubMed 22862951Xiaobin F, Shuguo Z, Jian Z, Yudong Q, Lijian L, Kuansheng M, Xiaowu L, Feng X, Dong Y, Shuguang W, Ping B, Jiahong D. Effect of the pringle maneuver on tumor recurrence of hepatocellular carcinoma after curative resection (EPTRH): a randomized, prospective, controlled multicenter trial. BMC Cancer. 2012 Aug 3;12:340. doi: 10.1186/1471-2407-12-340.
- ProtocolLink provided by the sponsor.
Related trials for Hepatocellular Carcinoma
RecruitingObservational study
Real-world Evaluation of the HistoSonics Edison System for Treatment of Liver Tumors Across Multidisciplinary Users (BOOMBOX: Master Study)
Liver Neoplasms, Primary Liver Cancer
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
RecruitingObservational study
A Study to Evaluate Patient-Reported Satisfaction, Effectiveness, and Safety of Atezolizumab in Participants Treated in Routine Clinical Practice
Lung Cancer, Hepatocellular Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dong Jiahong, Ph D study director
Institue of hepatobiliary surgery,Chinese PLA General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing curative resection without Pringle and curative resection with Pringle manoeuvre in people with Hepatocellular Carcinoma, run by Southwest Hospital, China 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 6 inclusion and 4 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 27 Nov 2012. 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?
Disease free survival (time frame: 1,3,5-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 NCT00725335, which also lists 1 linked publication.
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 27 Nov 2012.