Biliary StonesNCT01563510

Research of the Key Technology and Standardization of Minimal Invasive Treatment for Hepatolithiasis

A study testing Laparoscopic operation and Open operation in people with Biliary Stones, run by Shuguo Zheng, MD at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Biliary Stones
What is being tested?: Laparoscopic operation and Open operation
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 100 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 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
Liver function > Child-pugh level B, no severe biliary cirrhosis, ICG ≤ 15%, the residual liver volume and standard liver volume ratio ≥ 40%
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

Age: older than 70 years old, younger than 18 years old
Patients with bad general condition or important organ lesions, liver resection could not be tolerated
Complicated case needed to get emergency operation
Combined with severe liver atrophy hypertrophy syndrome, hepatic portal transposition or hilar biliary fibrosis / stenosis
Combined with severe biliary cirrhosis and portal hypertension, severe varicose of hepatic portal vein , hepatic insufficiency
Diagnosed with cholangiocellular carcinoma intraoperatively or by postoperative pathology
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

Institute of Hepatobiliary Surgery ,Southwest Hospital ,Third Military Medical University
Chongqing, Chongqing Municipality, 400038

Other trials in China

About this study

Official title: Comparison of Laparoscopic Versus Open Operation for Hepatolithiasis

The purpose of this research is to investigate the key technology and the related issues of minimal invasive treatment for hepatolithiasis and to build new methods of minimal invasive operation for hepatolithiasis. The validity, feasibility and limitations of the laparoscopic operation were assessed objectively through our clinical prospective study. The technique points, indications and contraindications were summarized to evaluate the status and role of minimal invasive laparoscopic operation in the treatment of hepatolithiasis.

Read the detailed description

Background: China is the high incidence area of hepatolithiasis. The development of minimal invasive techniques opened up a new situation for the treatment of hepatolithiasis, but it has not been widely applied.

Intervention: Comparison of minimal invasive versus open operation for hepatolithiasis: a prospective randomized study. One hundred patients with early regional hepatolithiasis were selected and divided into laparoscopic operation group and open operation group randomly, each group contains 50 cases. Laparoscopic anatomical hepatectomy or open regular hepatectomy were performed respectively, combined with cholecystectomy and bile duct exploration when necessary. The intraoperative ultrasound and choledochoscope were used selectively.

Results:

Clinical data: previous operation history, operation time, intraoperative blood loss, volume of blood transfusion, complications and mortality, postoperative liver function, residual stones, recurrence rate, long-term curative effect and survival time were collected and analysed.
Statistical method: univariate/multivariate analysis, logistic regression analysis, mixed linear regression, Cox survival analysis were used.

Conditions: Biliary Stones
Being tested: Laparoscopic operation, Open operation
Keywords: Hepatolithiasis, Minimal invasive surgery, Laparoscopic hepatectomy, Choledochoscope
Medical subject headings: Cholecystolithiasis

What participants receive

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

Laparoscopic operationProcedure or surgery
Also called Laparoscopic hepatectomy for early regional hepatolithiasis
Fifty patients with early regional hepatolithiasis were selected and divided into laparoscopic hepatectomy group as described in the detailed description. Total laparoscopic anatomical hepatectomy were performed, combined with cholecystectomy and bile duct exploration when necessary. The intraoperative ultrasound, choledochoscope and hepatic segmental staining were used selectively.
Open operationProcedure or surgery
Also called Open operation for regional hepatolithiasis
Fifty patients with early regional hepatolithiasis were selected and divided into open group as described in the detailed description. The traditional open regular hepatectomy were performed, combined with cholecystectomy and bile duct exploration when necessary. The intraoperative ultrasound and choledochoscope were used selectively.

Study groups in NCT01563510
Study group	Role	What they receive
Laparoscopic operation	Experimental	Total laparoscopic anatomical hepatectomy were performed, combined with cholecystectomy and bile duct exploration when necessary. The intraoperative ultrasound, choledochoscope and hepatic segmental staining were used selectively. Receives: Procedure: Laparoscopic operation
Open operation	Active comparator	The traditional open regular hepatectomy were performed, combined with cholecystectomy and bile duct exploration when necessary. The intraoperative ultrasound and choledochoscope were used selectively. Receives: Procedure: Open operation

What is being measured

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

Number of participants with residual stones or cholangitis symptoms
Liver function, recurrence rate, cholangitis symptoms, quality of life and survival time were collected and analysed to evaluate the postoperative curative effect. The follow up interval time: every six months.
Measured: up to 5 years postoperation

Secondary outcomes (1)

Number of participants with operation complication
Operation time, intraoperative blood loss, volume of blood transfusion, complications and mortality, postoperative liver function, residual stones were collected and analysed to evaluate the safety and effectiveness of the operation.
Measured: Duration hospitalization(an expected average of 2 weeks) to 2 months postoperation

Timeline

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

Jan 2012Dec 2017

First posted27 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 (9)Papers the sponsor has linked to this study.
Other trials for Biliary StonesStudies 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: 100 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01563510
Sponsor's protocol ID: SWHZSG001
Other IDs: zhengshuguo
Status last verified: Oct 2012
First submitted: 21 Mar 2012
Last updated: 10 Oct 2012
Results posted: No
Data monitoring committee: Yes

Publications

Uchiyama K, Kawai M, Ueno M, Ozawa S, Tani M, Yamaue H. Reducing residual and recurrent stones by hepatectomy for hepatolithiasis. J Gastrointest Surg. 2007 May;11(5):626-30. doi: 10.1007/s11605-006-0024-8.
PubMed 17468921
Lee SK, Seo DW, Myung SJ, Park ET, Lim BC, Kim HJ, Yoo KS, Park HJ, Joo YH, Kim MH, Min YI. Percutaneous transhepatic cholangioscopic treatment for hepatolithiasis: an evaluation of long-term results and risk factors for recurrence. Gastrointest Endosc. 2001 Mar;53(3):318-23. doi: 10.1016/s0016-5107(01)70405-1.
PubMed 11231390
Uenishi T, Hamba H, Takemura S, Oba K, Ogawa M, Yamamoto T, Tanaka S, Kubo S. Outcomes of hepatic resection for hepatolithiasis. Am J Surg. 2009 Aug;198(2):199-202. doi: 10.1016/j.amjsurg.2008.08.020. Epub 2009 Feb 27.
PubMed 19249730
Otani K, Shimizu S, Chijiiwa K, Ogawa T, Morisaki T, Sugitani A, Yamaguchi K, Tanaka M. Comparison of treatments for hepatolithiasis: hepatic resection versus cholangioscopic lithotomy. J Am Coll Surg. 1999 Aug;189(2):177-82. doi: 10.1016/s1072-7515(99)00109-x.
PubMed 10437840
Buell JF, Cherqui D, Geller DA, O'Rourke N, Iannitti D, Dagher I, Koffron AJ, Thomas M, Gayet B, Han HS, Wakabayashi G, Belli G, Kaneko H, Ker CG, Scatton O, Laurent A, Abdalla EK, Chaudhury P, Dutson E, Gamblin C, D'Angelica M, Nagorney D, Testa G, Labow D, Manas D, Poon RT, Nelson H, Martin R, Clary B, Pinson WC, Martinie J, Vauthey JN, Goldstein R, Roayaie S, Barlet D, Espat J, Abecassis M, Rees M, Fong Y, McMasters KM, Broelsch C, Busuttil R, Belghiti J, Strasberg S, Chari RS; World Consensus Conference on Laparoscopic Surgery. The international position on laparoscopic liver surgery: The Louisville Statement, 2008. Ann Surg. 2009 Nov;250(5):825-30. doi: 10.1097/sla.0b013e3181b3b2d8.
PubMed 19916210
Lai EC, Ngai TC, Yang GP, Li MK. Laparoscopic approach of surgical treatment for primary hepatolithiasis: a cohort study. Am J Surg. 2010 May;199(5):716-21. doi: 10.1016/j.amjsurg.2009.02.007. Epub 2009 Dec 3.
PubMed 19959158
Cho JY, Han HS, Yoon YS, Shin SH. Experiences of laparoscopic liver resection including lesions in the posterosuperior segments of the liver. Surg Endosc. 2008 Nov;22(11):2344-9. doi: 10.1007/s00464-008-9966-0. Epub 2008 Jun 5.
PubMed 18528623
Zhang L, Chen YJ, Shang CZ, Zhang HW, Huang ZJ. Total laparoscopic liver resection in 78 patients. World J Gastroenterol. 2009 Dec 7;15(45):5727-31. doi: 10.3748/wjg.15.5727.
PubMed 19960572
Nguyen 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 19801936

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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RecruitingObservational study
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Recruiting
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All Biliary Stones trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of Laparoscopic Versus Open Operation for Hepatolithiasis
ClinicalTrials.gov ID: NCT01563510
Acronym / sponsor ID: SWHZSG001
Conditions: Biliary Stones
Keywords: Hepatolithiasis, Minimal invasive surgery, Laparoscopic hepatectomy, Choledochoscope
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 100 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: 27 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.

Detailed description

Results:

Clinical data: previous operation history, operation time, intraoperative blood loss, volume of blood transfusion, complications and mortality, postoperative liver function, residual stones, recurrence rate, long-term curative effect and survival time were collected and analysed.
Statistical method: 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
Laparoscopic operation	Experimental	Procedure: Laparoscopic operationTotal laparoscopic anatomical hepatectomy were performed, combined with cholecystectomy and bile duct exploration when necessary. The intraoperative ultrasound, choledochoscope and hepatic segmental staining were used selectively.
Open operation	Active comparator	Procedure: Open operationThe traditional open regular hepatectomy were performed, combined with cholecystectomy and bile duct exploration when necessary. The intraoperative ultrasound and choledochoscope were used selectively.

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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
Liver function > Child-pugh level B, no severe biliary cirrhosis, ICG ≤ 15%, the residual liver volume and standard liver volume ratio ≥ 40%
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

Key exclusion criteria (7 listed)

Age: older than 70 years old, younger than 18 years old
Patients with bad general condition or important organ lesions, liver resection could not be tolerated
Complicated case needed to get emergency operation
Combined with severe liver atrophy hypertrophy syndrome, hepatic portal transposition or hilar biliary fibrosis / stenosis
Combined with severe biliary cirrhosis and portal hypertension, severe varicose of hepatic portal vein , hepatic insufficiency

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
Laparoscopic operationAlso: Laparoscopic hepatectomy for early regional hepatolithiasisFifty patients with early regional hepatolithiasis were selected and divided into laparoscopic hepatectomy group as described in the detailed description. Total laparoscopic anatomical hepatectomy were performed, combined with cholecystectomy and bile duct exploration when necessary. The intraoperative ultrasound, choledochoscope and hepatic segmental staining were used selectively.	Procedure or surgery	Laparoscopic operation
Open operationAlso: Open operation for regional hepatolithiasisFifty patients with early regional hepatolithiasis were selected and divided into open group as described in the detailed description. The traditional open regular hepatectomy were performed, combined with cholecystectomy and bile duct exploration when necessary. The intraoperative ultrasound and choledochoscope were used selectively.	Procedure or surgery	Open operation

Primary outcome

Number of participants with residual stones or cholangitis symptoms
Time frame: up to 5 years postoperation
Liver function, recurrence rate, cholangitis symptoms, quality of life and survival time were collected and analysed to evaluate the postoperative curative effect. The follow up interval time: every six months.

1 secondary outcome

Number of participants with operation complication
Time frame: Duration hospitalization(an expected average of 2 weeks) to 2 months postoperation

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2012.
Background: PubMed 17468921Uchiyama K, Kawai M, Ueno M, Ozawa S, Tani M, Yamaue H. Reducing residual and recurrent stones by hepatectomy for hepatolithiasis. J Gastrointest Surg. 2007 May;11(5):626-30. doi: 10.1007/s11605-006-0024-8.
Background: PubMed 11231390Lee SK, Seo DW, Myung SJ, Park ET, Lim BC, Kim HJ, Yoo KS, Park HJ, Joo YH, Kim MH, Min YI. Percutaneous transhepatic cholangioscopic treatment for hepatolithiasis: an evaluation of long-term results and risk factors for recurrence. Gastrointest Endosc. 2001 Mar;53(3):318-23. doi: 10.1016/s0016-5107(01)70405-1.
Background: PubMed 19249730Uenishi T, Hamba H, Takemura S, Oba K, Ogawa M, Yamamoto T, Tanaka S, Kubo S. Outcomes of hepatic resection for hepatolithiasis. Am J Surg. 2009 Aug;198(2):199-202. doi: 10.1016/j.amjsurg.2008.08.020. Epub 2009 Feb 27.
Background: PubMed 10437840Otani K, Shimizu S, Chijiiwa K, Ogawa T, Morisaki T, Sugitani A, Yamaguchi K, Tanaka M. Comparison of treatments for hepatolithiasis: hepatic resection versus cholangioscopic lithotomy. J Am Coll Surg. 1999 Aug;189(2):177-82. doi: 10.1016/s1072-7515(99)00109-x.
Background: PubMed 19916210Buell JF, Cherqui D, Geller DA, O'Rourke N, Iannitti D, Dagher I, Koffron AJ, Thomas M, Gayet B, Han HS, Wakabayashi G, Belli G, Kaneko H, Ker CG, Scatton O, Laurent A, Abdalla EK, Chaudhury P, Dutson E, Gamblin C, D'Angelica M, Nagorney D, Testa G, Labow D, Manas D, Poon RT, Nelson H, Martin R, Clary B, Pinson WC, Martinie J, Vauthey JN, Goldstein R, Roayaie S, Barlet D, Espat J, Abecassis M, Rees M, Fong Y, McMasters KM, Broelsch C, Busuttil R, Belghiti J, Strasberg S, Chari RS; World Consensus Conference on Laparoscopic Surgery. The international position on laparoscopic liver surgery: The Louisville Statement, 2008. Ann Surg. 2009 Nov;250(5):825-30. doi: 10.1097/sla.0b013e3181b3b2d8.
Background: PubMed 19959158Lai EC, Ngai TC, Yang GP, Li MK. Laparoscopic approach of surgical treatment for primary hepatolithiasis: a cohort study. Am J Surg. 2010 May;199(5):716-21. doi: 10.1016/j.amjsurg.2009.02.007. Epub 2009 Dec 3.
Background: PubMed 18528623Cho JY, Han HS, Yoon YS, Shin SH. Experiences of laparoscopic liver resection including lesions in the posterosuperior segments of the liver. Surg Endosc. 2008 Nov;22(11):2344-9. doi: 10.1007/s00464-008-9966-0. Epub 2008 Jun 5.
Background: PubMed 19960572Zhang L, Chen YJ, Shang CZ, Zhang HW, Huang ZJ. Total laparoscopic liver resection in 78 patients. World J Gastroenterol. 2009 Dec 7;15(45):5727-31. doi: 10.3748/wjg.15.5727.
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.

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Effect of Prophylactic Dexamethasone vs Placebo on Airway Dimensions Assessed by Ultrasonography in Patients Undergoing Laparoscopic Cholecystectomy
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Two Bupivacaine Concentrations for Recto-Intercostal Fascial Plane Block After Laparoscopic Cholecystectomy
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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, 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 Laparoscopic operation and Open operation in people with Biliary Stones, 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 5 inclusion and 7 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 10 Oct 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?

Results are not available in the source record.

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?

Number of participants with residual stones or cholangitis symptoms (time frame: up to 5 years postoperation). 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 NCT01563510, which also lists 9 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 10 Oct 2012.