Liver ResectionNCT01355887
A Trial to Compare Pringle Maneuver With Either Infrahepatic Inferior Vena Cava Clamping or Low Central Venous Pressure
An observational study of Liver Resection, run by Huazhong University of Science and Technology at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Liver Resection
- How many people
- 192 participants
- Where
- 1 siteChina
- Study dates
- Jan 2008to Dec 2011
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: During the study period, all patients who received liver resections were considered to be included into this study.
Who may be able to join
- 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.
Who cannot join
- extrahepatic metastases in patients with malignancy;
- patients who refused to take part in this study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Hepatic surgery center, Tong ji Hospital
Wuhan, Hubei, 430030
Xiaoping Chen, Doctor, 8602783662851, chenxp@medmail.com.cn
peng zhu, doctor
About this study
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
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.
Read the detailed description
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.
- Conditions
- Liver Resection
- Keywords
- blood loss, hepatectomy, prospective study, PTC
- Medical subject headings
- Hemorrhage
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2011 (estimated)
- Study startJan 2008
- Primary completionDec 2011 (estimated)
- Study completionDec 2011 (estimated)
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 Liver ResectionStudies of the same condition, open and under way.
- More trials run by Huazhong University of Science and TechnologyThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 192 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Chinese University of Hong Kong
- Investigators
- Xiaoping Chen, Doctor, Study director, Hepatic Surgery Center, Tongji Hospital, Tongji Medical college, Huazhong University of Science and Technology, Wuhan, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01355887
- Sponsor's protocol ID
- CHENXP003
- Status last verified
- Jan 2008
- First submitted
- 16 May 2011
- Last updated
- 18 May 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Zhu P, Lau WY, Chen YF, Zhang BX, Huang ZY, Zhang ZW, Zhang W, Dou L, Chen XP. Randomized clinical trial comparing infrahepatic inferior vena cava clamping with low central venous pressure in complex liver resections involving the Pringle manoeuvre. Br J Surg. 2012 Jun;99(6):781-8. doi: 10.1002/bjs.8714. Epub 2012 Mar 2.
PubMed 22389136
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01355887
- Acronym / sponsor ID
- CHENXP003
- Conditions
- Liver Resection
- Keywords
- blood loss, hepatectomy, prospective study, PTC
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 192 participants (estimated)
- Lead sponsor
- Huazhong University of Science and TechnologyUniversity, hospital or other
- Collaborators
- Chinese University of Hong Kong
- Study start
- Jan 2008
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 18 May 2011 (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.
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.
Detailed description
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- During the study period, all patients who received liver resections were considered to be included into this study.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- extrahepatic metastases in patients with malignancy;
- patients who refused to take part in this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2011.
- Derived from this study: PubMed 22389136Zhu P, Lau WY, Chen YF, Zhang BX, Huang ZY, Zhang ZW, Zhang W, Dou L, Chen XP. Randomized clinical trial comparing infrahepatic inferior vena cava clamping with low central venous pressure in complex liver resections involving the Pringle manoeuvre. Br J Surg. 2012 Jun;99(6):781-8. doi: 10.1002/bjs.8714. Epub 2012 Mar 2.
Related trials for Liver Resection
Not yet recruitingPhase 2
NIVO+IPI Neoadjuvant Therapy for Recurrent Resectable HCC
Hepatocellular Carcinoma (HCC), Recurrent Hepatocellular Cancer
Not yet recruiting
RAPID for Unresectable Colorectal Liver Metastases
Colorectal Liver Metastases (CRCLM), Colorectal Neoplasms
RecruitingPhase 4
Remimazolam Versus Propofol for Maintenance of Anaesthesia During Major Hepatectomy Under Low Central Venous Pressure
Intraoperative Hypotension, Hepatectomy
RecruitingPhase 2
Circulating Tumor DNA Methylation-Guided Adjuvant Therapy Decision-Making in Patients With Resectable Colorectal Cancer Liver Metastases After Resection
Colorectal Cancer Liver Metastases (CRLM), ctDNA
Recruiting
Implementation of a Pain Management Plan in Major Open Abdominal Surgeries.
Abdomen Cancer, Pancreas Adenocarcinoma (MSI-H)
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.
Xiaoping Chen, Doctor study director
Hepatic Surgery Center, Tongji Hospital, Tongji Medical college, Huazhong University of Science and Technology, Wuhan, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Resection, run by Huazhong University of Science and Technology 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 5 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 18 May 2011. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaoping Chen, doctor (8602783662851 ext. 430030, chenxp@medmail.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01355887, 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 18 May 2011.