Liver DiseasesLAHIGANCT01567631
Classical Procedure Versus Intrahepatic Glisson's Approach
A study testing intrahepatic Glisson's approach and classical hepatectomy in people with Liver Diseases and Liver Neoplasms, run by Shuguo Zheng, MD at 1 site in China.
Trial summary
The purpose of this research is to compare the classical procedure with intrahepatic Glisson's approach for laparoscopic anatomical hepatectomy. The validity, feasibility and limitations were assessed objectively through our clinical prospective study. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Liver Diseases, Liver Neoplasms, Hepatic Haemangioma
- What is being tested?
- intrahepatic Glisson's approach and classical hepatectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- Jan 2012to Dec 2017
- 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
- Patients with liver malignant or benign disease distributed in a segment, lobe or half liver, malignant tumor ≤5 cm, without rupture, bleeding, and liver metastases, benign tumor ≤15cm.
- Liver function > Child-pugh level B, no severe biliary cirrhosis, ICG ≤ 15%, the residual liver volume and standard liver volume ratio ≥ 40%. The conditions of open hepatectomy were achieved
- Age: Between 18 to 70 years
- Patients with regional stones distributed in a segment, lobe or half liver, combined or not combined with extrahepatic biliary calculi, hepatic parenchymal atrophy or fibrosis in the lesion region
- Patients with good general condition, the conditions of open Anatomical Hepatectomy were achieved
- Other organ lesions and previous biliary tract operation is not the absolute exclusion criteria
- Written informed consent
Who cannot join
- Patients with bad general condition or important organ lesions, liver resection could not be tolerated
- Age:Younger than 18 or more than 70 years old
- Malignant tumor recurrence within one month postoperation
- Combined with severe liver atrophy hypertrophy syndrome, hepatic portal transposition or hilar biliary fibrosis / stenosis
- Complicated case need to get emergency operation
- Contraindication of laparoscopy: Combined with complicated acute cholangitis, repeated biliary tract operation, heavy intra-abdominal adhesion, Trocar can not be placed in. Artificial pneumoperitoneum could not be tolerated
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Southwest Hospital
Chongqing, Chongqing Municipality, 400038
Shuguo Zheng, Professor, 0086-13508308676, shuguozh@yahoo.com.cn
shuguo Zheng, professer
About this study
Official title: Laparoscopic Anatomical Hepatectomy With Intrahepatic Glisson's Approach Versus Laparoscopic Anatomical Hepatectomy With Classical Procedure
The purpose of this research is to compare the classical procedure with intrahepatic Glisson's approach for laparoscopic anatomical hepatectomy. The validity, feasibility and limitations were assessed objectively through our clinical prospective study. The investigators expect laparoscopic anatomical hepatectomy with intrahepatic Glisson's approach is safe, effective and feasible.
Read the detailed description
Background: China is the high incidence area of liver disease, some of which need to be treated by surgical liver resection. The development of minimal invasive techniques opened up a new situation for hepatectomy. Intrahepatic Glisson's approach and the classical procedure are the two major operation procedures used in laparoscopic hepatectomy. The intrahepatic Glisson's approach has the advantages of less intraoperative bleeding and shorter operation time in our experience and as previous studies. The investigators expect further comparison of the safety and efficacy through this prospective controlled study by using two kinds of operation procedures.
Intervention: Classical procedure versus intrahepatic Glisson's approach: a prospective randomized study. Eighty patients with liver disease need undergo hepatectomy were selected and divided into intrahepatic Glisson's group and classical procedure group randomly, each group contains 40 cases. Total laparoscopic hepatectomy were performed, with the intrahepatic Glisson's approach or classical procedure respectively.
Results:
- Clinical data include: operation time, intraoperative blood loss, volume of blood transfusion, complications and mortality, postoperative liver function,long-term curative effect were collected and analysed.
- Statistical method: groups t-test univariate/multivariate analysis, logistic regression analysis, mixed linear regression, Cox survival analysis were used.
- Conditions
- Liver Diseases, Liver Neoplasms, Hepatic Haemangioma
- Being tested
- intrahepatic Glisson's approach, classical hepatectomy
- Keywords
- Classical Procedure, Intrahepatic Glisson's Approach, laparoscopic hepatectomy, Minimal invasive surgery, Endoscopic stapling devices
- Medical subject headings
- Liver Diseases, Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intrahepatic Glisson's approachProcedure or surgery
Also called Laparoscopic with Intrahepatic Glssion's approach
Forty patients with liver disease were selected and divided into intrahepatic Glission's group as described in the detailed description.Total laparoscopic hepatectomy with intrahepatic Glisson's approach were performed. Operation began with division of liver ligaments, liver mobilization, followed by intrahepatic access to the Glissonian pedicle (containing arterial, portal, and bile duct branches ). A endoscopic stapler devices was used for Glissonian pedicle cutting and suture. Liver parenchyma was divided by harmonic scalpel combined with vascular stapler. The specimen was extracted through suprapubic incision.
classical hepatectomyProcedure or surgery
Also called Laparoscopic anatomical hepatectomy with classical procedure
Forty patients with liver disease were selected and divided into classical laparoscopic hepatectomy group as described in the detailed description.Total laparoscopic anatomical hepatectomy with classical procedure were performed.The initial step is to dissect hepatic portal and expose the liver artery, portal Vein branch and the bile duct. Then endoscopic stapler devices were used to cut the canal mentioned above. Final step is to divide the liver parenchyma along the following ischemic delineation.
| Study group | Role | What they receive |
|---|---|---|
| intrahepatic Glisson's approach | Experimental | Not described Receives: Procedure: intrahepatic Glisson's approach |
| classical hepatectomy | Active comparator | Not described Receives: Procedure: classical hepatectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with operation complication
Operation time, intraoperative blood loss, volume of blood transfusion, complications and mortality, postoperative liver function were collected and analysed to evaluate the safety of the operation.
Measured: Duration hospitalization(an expected average of 8 days)
Secondary outcomes (1)
Number of participants with abnormal liver function or discomfort symptoms induced by the operation
Liver function, quality of life and survival time were collected and analysed to evaluate the postoperative curative effect. The examination of ultrasound , CT and/or MR were perfomed in outpatient if necessary. The follow up interval time: every six months.
Measured: up to 3 years postoperation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2012 (estimated)
- Study startJan 2012
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Liver DiseasesStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shuguo Zheng, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Shuguo Zheng, MD, Southwest Hospital, China
- Investigators
- Shuguo Zheng, Study director, Shuguo Zheng, MD Study Director Institute of Hepatobiliary Surgery ,Southwest Hospital ,Third Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01567631
- Sponsor's protocol ID
- SWHZSG002
- Other IDs
- Zhengshuguo
- Acronym
- LAHIGA
- Status last verified
- Jan 2016
- First submitted
- 26 Mar 2012
- Last updated
- 1 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Topal B, Aerts R, Penninckx F. Laparoscopic intrahepatic Glissonian approach for right hepatectomy is safe, simple, and reproducible. Surg Endosc. 2007 Nov;21(11):2111. doi: 10.1007/s00464-007-9303-z. Epub 2007 May 4.
PubMed 17479334Cho A, Asano T, Yamamoto H, Nagata M, Takiguchi N, Kainuma O, Souda H, Gunji H, Miyazaki A, Nojima H, Ikeda A, Matsumoto I, Ryu M, Makino H, Okazumi S. Laparoscopy-assisted hepatic lobectomy using hilar Glissonean pedicle transection. Surg Endosc. 2007 Aug;21(8):1466-8. doi: 10.1007/s00464-007-9253-5. Epub 2007 Mar 14.
PubMed 17356935Cho A, Yamamoto H, Kainuma O, Souda H, Ikeda A, Takiguchi N, Nagata M. Safe and feasible extrahepatic Glissonean access in laparoscopic anatomical liver resection. Surg Endosc. 2011 Apr;25(4):1333-6. doi: 10.1007/s00464-010-1358-6. Epub 2010 Sep 25.
PubMed 20872017Astudillo JA, Sporn E, Serrano B, Astudillo R. Ascariasis in the hepatobiliary system: laparoscopic management. J Am Coll Surg. 2008 Oct;207(4):527-32. doi: 10.1016/j.jamcollsurg.2008.05.020. Epub 2008 Jul 14.
PubMed 18926454Lai EC, Tang CN, Ha JP, Li MK. Laparoscopic liver resection for hepatocellular carcinoma: ten-year experience in a single center. Arch Surg. 2009 Feb;144(2):143-7; discussion 148. doi: 10.1001/archsurg.2008.536.
PubMed 19221325Dagher I, Diop PS, Lainas P, Carloni A, Franco D. Laparoscopic liver resection for localized primary intrahepatic bile duct dilatation. Am J Surg. 2010 Jan;199(1):131-5. doi: 10.1016/j.amjsurg.2008.12.027. Epub 2009 Apr 17.
PubMed 19375067Gigot JF, Hubert C, Banice R, Kendrick ML. Laparoscopic management of benign liver diseases: where are we? HPB (Oxford). 2004;6(4):197-212. doi: 10.1080/13651820410023950.
PubMed 18333077Koffron AJ, Stein JA. Laparoscopic liver surgery: parenchymal transection using saline-enhanced electrosurgery. HPB (Oxford). 2008;10(4):225-8. doi: 10.1080/13651820802166864.
PubMed 18773098Gumbs AA, Gayet B, Gagner M. Laparoscopic liver resection: when to use the laparoscopic stapler device. HPB (Oxford). 2008;10(4):296-303. doi: 10.1080/13651820802166773.
PubMed 18773113Belli G, Fantini C, D'Agostino A, Belli A, Russolillo N. Laparoscopic liver resections for hepatocellular carcinoma (HCC) in cirrhotic patients. HPB (Oxford). 2004;6(4):236-46. doi: 10.1080/13651820410023941.
PubMed 18333081Nguyen KT, Gamblin TC, Geller DA. World review of laparoscopic liver resection-2,804 patients. Ann Surg. 2009 Nov;250(5):831-41. doi: 10.1097/SLA.0b013e3181b0c4df.
PubMed 19801936Liao KX, Yu F, Cao L, Wang BL, Li XS, Wang XJ, Li JW, Fan YD, Chen J, Zheng SG. Laparoscopic Glissonian pedicle versus hilar dissection approach hemihepatectomy: A prospective, randomized controlled trial. J Hepatobiliary Pancreat Sci. 2022 Jun;29(6):629-640. doi: 10.1002/jhbp.1129. Epub 2022 Mar 10.
PubMed 35224875
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Anatomical Hepatectomy With Intrahepatic Glisson's Approach Versus Laparoscopic Anatomical Hepatectomy With Classical Procedure
- ClinicalTrials.gov ID
- NCT01567631
- Acronym / sponsor ID
- LAHIGA / SWHZSG002
- Conditions
- Liver Diseases, Liver Neoplasms, Hepatic Haemangioma
- Keywords
- Classical Procedure, Intrahepatic Glisson's Approach, laparoscopic hepatectomy, Minimal invasive surgery, Endoscopic stapling devices
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Shuguo Zheng, MDUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 30 Mar 2012 (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 research is to compare the classical procedure with intrahepatic Glisson's approach for laparoscopic anatomical hepatectomy. The validity, feasibility and limitations were assessed objectively through our clinical prospective study. The investigators expect laparoscopic anatomical hepatectomy with intrahepatic Glisson's approach is safe, effective and feasible.
Detailed description
Background: China is the high incidence area of liver disease, some of which need to be treated by surgical liver resection. The development of minimal invasive techniques opened up a new situation for hepatectomy. Intrahepatic Glisson's approach and the classical procedure are the two major operation procedures used in laparoscopic hepatectomy. The intrahepatic Glisson's approach has the advantages of less intraoperative bleeding and shorter operation time in our experience and as previous studies. The investigators expect further comparison of the safety and efficacy through this prospective controlled study by using two kinds of operation procedures.
Intervention: Classical procedure versus intrahepatic Glisson's approach: a prospective randomized study. Eighty patients with liver disease need undergo hepatectomy were selected and divided into intrahepatic Glisson's group and classical procedure group randomly, each group contains 40 cases. Total laparoscopic hepatectomy were performed, with the intrahepatic Glisson's approach or classical procedure respectively.
Results:
- Clinical data include: operation time, intraoperative blood loss, volume of blood transfusion, complications and mortality, postoperative liver function,long-term curative effect were collected and analysed.
- Statistical method: groups t-test univariate/multivariate analysis, logistic regression analysis, mixed linear regression, Cox survival analysis were used.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intrahepatic Glisson's approach | Experimental | Procedure: intrahepatic Glisson's approach |
| classical hepatectomy | Active comparator | Procedure: classical hepatectomy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with liver malignant or benign disease distributed in a segment, lobe or half liver, malignant tumor ≤5 cm, without rupture, bleeding, and liver metastases, benign tumor ≤15cm.
- Liver function > Child-pugh level B, no severe biliary cirrhosis, ICG ≤ 15%, the residual liver volume and standard liver volume ratio ≥ 40%. The conditions of open hepatectomy were achieved
- Age: Between 18 to 70 years
- Patients with regional stones distributed in a segment, lobe or half liver, combined or not combined with extrahepatic biliary calculi, hepatic parenchymal atrophy or fibrosis in the lesion region
- Patients with good general condition, the conditions of open Anatomical Hepatectomy were achieved
Key exclusion criteria (6 listed)
- Patients with bad general condition or important organ lesions, liver resection could not be tolerated
- Age:Younger than 18 or more than 70 years old
- Malignant tumor recurrence within one month postoperation
- Combined with severe liver atrophy hypertrophy syndrome, hepatic portal transposition or hilar biliary fibrosis / stenosis
- Complicated case need to get emergency operation
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 |
|---|---|---|
| intrahepatic Glisson's approachAlso: Laparoscopic with Intrahepatic Glssion's approachForty patients with liver disease were selected and divided into intrahepatic Glission's group as described in the detailed description.Total laparoscopic hepatectomy with intrahepatic Glisson's approach were performed. Operation began with division of liver ligaments, liver mobilization, followed by intrahepatic access to the Glissonian pedicle (containing arterial, portal, and bile duct branches ). A endoscopic stapler devices was used for Glissonian pedicle cutting and suture. Liver parenchyma was divided by harmonic scalpel combined with vascular stapler. The specimen was extracted through suprapubic incision. | Procedure or surgery | intrahepatic Glisson's approach |
| classical hepatectomyAlso: Laparoscopic anatomical hepatectomy with classical procedureForty patients with liver disease were selected and divided into classical laparoscopic hepatectomy group as described in the detailed description.Total laparoscopic anatomical hepatectomy with classical procedure were performed.The initial step is to dissect hepatic portal and expose the liver artery, portal Vein branch and the bile duct. Then endoscopic stapler devices were used to cut the canal mentioned above. Final step is to divide the liver parenchyma along the following ischemic delineation. | Procedure or surgery | classical hepatectomy |
Primary outcome
Number of participants with operation complication
Time frame: Duration hospitalization(an expected average of 8 days)
Operation time, intraoperative blood loss, volume of blood transfusion, complications and mortality, postoperative liver function were collected and analysed to evaluate the safety of the operation.
1 secondary outcome
Number of participants with abnormal liver function or discomfort symptoms induced by the operation
Time frame: up to 3 years postoperation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2016.
- Background: PubMed 17479334Topal B, Aerts R, Penninckx F. Laparoscopic intrahepatic Glissonian approach for right hepatectomy is safe, simple, and reproducible. Surg Endosc. 2007 Nov;21(11):2111. doi: 10.1007/s00464-007-9303-z. Epub 2007 May 4.
- Background: PubMed 17356935Cho A, Asano T, Yamamoto H, Nagata M, Takiguchi N, Kainuma O, Souda H, Gunji H, Miyazaki A, Nojima H, Ikeda A, Matsumoto I, Ryu M, Makino H, Okazumi S. Laparoscopy-assisted hepatic lobectomy using hilar Glissonean pedicle transection. Surg Endosc. 2007 Aug;21(8):1466-8. doi: 10.1007/s00464-007-9253-5. Epub 2007 Mar 14.
- Background: PubMed 20872017Cho A, Yamamoto H, Kainuma O, Souda H, Ikeda A, Takiguchi N, Nagata M. Safe and feasible extrahepatic Glissonean access in laparoscopic anatomical liver resection. Surg Endosc. 2011 Apr;25(4):1333-6. doi: 10.1007/s00464-010-1358-6. Epub 2010 Sep 25.
- Background: PubMed 18926454Astudillo JA, Sporn E, Serrano B, Astudillo R. Ascariasis in the hepatobiliary system: laparoscopic management. J Am Coll Surg. 2008 Oct;207(4):527-32. doi: 10.1016/j.jamcollsurg.2008.05.020. Epub 2008 Jul 14.
- Background: PubMed 19221325Lai EC, Tang CN, Ha JP, Li MK. Laparoscopic liver resection for hepatocellular carcinoma: ten-year experience in a single center. Arch Surg. 2009 Feb;144(2):143-7; discussion 148. doi: 10.1001/archsurg.2008.536.
- Background: PubMed 19375067Dagher I, Diop PS, Lainas P, Carloni A, Franco D. Laparoscopic liver resection for localized primary intrahepatic bile duct dilatation. Am J Surg. 2010 Jan;199(1):131-5. doi: 10.1016/j.amjsurg.2008.12.027. Epub 2009 Apr 17.
- Background: PubMed 18333077Gigot JF, Hubert C, Banice R, Kendrick ML. Laparoscopic management of benign liver diseases: where are we? HPB (Oxford). 2004;6(4):197-212. doi: 10.1080/13651820410023950.
- Background: PubMed 18773098Koffron AJ, Stein JA. Laparoscopic liver surgery: parenchymal transection using saline-enhanced electrosurgery. HPB (Oxford). 2008;10(4):225-8. doi: 10.1080/13651820802166864.
- Background: PubMed 18773113Gumbs AA, Gayet B, Gagner M. Laparoscopic liver resection: when to use the laparoscopic stapler device. HPB (Oxford). 2008;10(4):296-303. doi: 10.1080/13651820802166773.
- Background: PubMed 18333081Belli G, Fantini C, D'Agostino A, Belli A, Russolillo N. Laparoscopic liver resections for hepatocellular carcinoma (HCC) in cirrhotic patients. HPB (Oxford). 2004;6(4):236-46. doi: 10.1080/13651820410023941.
- Background: PubMed 19801936Nguyen KT, Gamblin TC, Geller DA. World review of laparoscopic liver resection-2,804 patients. Ann Surg. 2009 Nov;250(5):831-41. doi: 10.1097/SLA.0b013e3181b0c4df.
- Derived from this study: PubMed 35224875Liao KX, Yu F, Cao L, Wang BL, Li XS, Wang XJ, Li JW, Fan YD, Chen J, Zheng SG. Laparoscopic Glissonian pedicle versus hilar dissection approach hemihepatectomy: A prospective, randomized controlled trial. J Hepatobiliary Pancreat Sci. 2022 Jun;29(6):629-640. doi: 10.1002/jhbp.1129. Epub 2022 Mar 10.
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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.
Shuguo Zheng study director
Shuguo Zheng, MD Study Director Institute of Hepatobiliary Surgery ,Southwest Hospital ,Third Military Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intrahepatic Glisson's approach and classical hepatectomy in people with Liver Diseases and Liver Neoplasms, 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 7 inclusion and 6 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 1 Feb 2016. 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 Shuguo Zheng (0086-13508308676, shuguozh@yahoo.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with operation complication (time frame: Duration hospitalization(an expected average of 8 days)). 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 NCT01567631, which also lists 12 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 1 Feb 2016.