CholedocholithiasisNCT02515474
Comparison of LCBDE vs ERCP + LC for Choledocholithiasis
A study testing Laparoscopy and Endoscopy in people with Choledocholithiasis, run by Hepatopancreatobiliary Surgery Institute of Gansu Province at 12 sites in China.
Trial summary
Protection of Oddi's sphincter remains a huge argument especially in the long term complications like common bile duct stone recurrence or cholangitis after ERCP, which determined to destroy the sphincter of Oddi. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Choledocholithiasis
- What is being tested?
- Laparoscopy and Endoscopy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 12 sitesChina
- Study dates
- 1 Sep 2015to 1 Jan 2024
- 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
- Age 18-65 years old
- Choledocholithiasis patient did not perform any operation
- Common bile duct stone less than 2cm in maximum diameter
Who cannot join
- Unwillingness or inability to consent for the study
- Coagulation dysfunction (INR> 1.3) and low peripheral blood platelet count (<50×109 / L) or using anti-coagulation drugs
- Previous EST, EPBD or percutaneous transhepatic biliary drainage (PTBD)
- Prior surgery of Bismuth Ⅱ and Roux-en-Y
- Benign or malignant CBD stricture
- Preoperative coexistent diseases: acute pancreatitis, GI tract hemorrhage, severe liver disease, primary sclerosing cholangitis (PSC), septic shock
Show all 10Show fewer
- Combined with Mirizzi syndrome and intrahepatic bile duct stones
- Malignancies
- Biliary-duodenal fistula confirmed during ERCP
- Pregnant women
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
China12 sites
The First Hospital of Jilin University
Changchun, Jilin, 130021
Second Xiangya Hospital, Central South University
Changsha, Hunan, 410011
Southwest Hospital of Third Military Medical University
Chongqing, 400038
The First Affiliated Hospital, Zhejiang University
Hangzhou, Zhejiang, 310003
Shandong jiaotong Hospital
Jinan, Shandong, 250000
The first hospital of Lanzhou University
Lanzhou, Gansu, 730000
Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, 200092
Tianjin Nankai Hospital
Tianjin, 300100
The First Teaching Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, 830054
Union hospital,Tongji medical collage,Huazhong University of science and technology
Wuhan, Hubei, 430022
The first affiliated hospital of Xi 'an jiaotong university
Xi’an, Shanxi, 710061
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, 750004
About this study
Official title: A Long Term Comparison of Laparoscopic Common Bile Duct Exploration and Cholecystectomy Versus Sequential ERCP Followed by Cholecystectomy for Choledocholithiasis: a Multicenter Prospected Non-randomized Controlled Study
Protection of Oddi's sphincter remains a huge argument especially in the long term complications like common bile duct stone recurrence or cholangitis after ERCP, which determined to destroy the sphincter of Oddi. The purpose of this study is to compare the long-term outcomes of ERCP sequential LC versus LCBDE for choledocholithiasis.
Read the detailed description
Cholelithiasis, a common etiology factor responsible for abdominal pain, is highly prevalent worldwide. According to data from general investigation, the morbidity of cholelithiasis differs from 2.36% to 42% in different areas, and about 5% to 29% (average 18%) of all cholelithiasis cases have both gallbladder stone and common bile duct stone. In the population with age above 70 years old, 30% of which suffers from gallbladder stone in China. A causal link between the development of gallbladder stone and common bile duct stone is that 10% to 15% of gallstone patients have high potential to develop secondary common bile duct stone. In 1987, the laparoscopic cholecystectomy (LC) came into being as a revolutionary surgical method. With minimally invasive effect and high safety, LC was soon accepted as a 'Golden standard' for the treatment of gallbladder stone. Endoscopic sphincterotomy (EST) was firstly reported by Kawai and Classen in 1970. As of now, the combination of EST with other endoscopic techniques, such as basket extraction, balloon dilation and lithotripsy, have significantly improved the stone removal rate from 85% up to 90%, and ERCP has been considered as the optimal method in regard to CBD stone treatment. In 1991, the laparoscopic common bile duct exploration (LCBDE) which reflected the advantage of rigid scopes had risen to be a very promising minimally invasive alternative for the treatment of common bile duct (CBD) stone. Currently, there are mainly two kinds of minimally invasive treatments for choledocholithiasis, which refers to the "one-stage" laparoscopic method, LCBDE and the "sequential two-stage" method, ERCP followed by LC. Both methods are able to achieve the same therapeutic purpose. However, there has always been a controversy about the advantages and disadvantages due to lack of evidence from long-term follow-ups, especially the difference of long-term complications related to Oddi's sphincter functional status, which importantly refers to stone recurrence rates and cholangitis.
The potential long-term complications resulted from EST remains an issue now. It is believed that EST handles Oddi's sphincter stenosis, regurgitation cholangitis, and higher cholangiocarcinoma risks in a long run. By virtue of ERCP, multiple high stone clearance rates (87%~97%) were reported, but meanwhile high re-ERCP rates (around 25%) were also indicated because of stone residual, and whether great stone residual rates was linked to future stone recurrence and repeated cholangitis is not clear. Several randomized controlled trial (RCT) studies had compared ERCP plus LC and LCBDE, the results were similar to the aspects of stone removal rates, costs, and patient acceptance. However, the postoperative cholangitis rate of one single center study is quite different from another. Moreover, few studies have related the stone recurrence rate in the long term follow-up. Obviously, previous RCT studies were limited by few comparison of ERCP followed by LC versus LCBDE in long-term complications, especially stone recurrence and cholangitis. Therefore, this multicenter randomize control study is designed prospectively to compare the stone recurrence and cholangitis rates between ERCP plus LC and LCBDE which can reflects the valuable of Oddi's sphincter protection during the disease management, further dedicating the treatment of gallbladder and common duct stone.
- Conditions
- Choledocholithiasis
- Being tested
- Laparoscopy, Endoscopy
- Keywords
- Cholangiopancreatography, Endoscopic, Common bile duct, Complication, Recurrence, Laparoscopic
- Medical subject headings
- Choledocholithiasis, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LaparoscopyProcedure or surgery
Also called Laparoscopic common bile duct exploration (LCBDE)
After removing the gallbladder, Laparoscopic common bile duct exploration (LCBDE) was performed by one fulltime attending in laparoscopy in a routine fashion. Access from the opening of the anterior wall of common bile duct or from the dilated cystic duct was acceptable, removed stone(s) and irrigated the duct followed by choledochoscope detection simultaneously. Cholangiograms were also can be a alternative method to obtain stone clearance. If needed, all fluoroscopy was performed by the principal author in the presence of and concurrence with the ERCP endoscopist. Once the LCBDE was completed, the incision of the bile duct was sewed intermittently by absorbed threads, or ligated cystic duct. T-tube was acceptable if needed.
EndoscopyProcedure or surgery
Also called Endoscopic Retrograde cholangiopancreatography (ERCP)
Initially endoscopic retrograde cholangiopancreatography (ERCP) was performed by a fulltime attending and concurrence of the principal author in endoscopy. Patients randomized to ERCP+ LC group were scheduled to undergo the endoscopic procedure using fluoroscopy in the endoscopy center under moderate sedation (principally intravenous midazolam and meperidine) prior to the intended laparoscopy. Gastric intestinal atony during ERCP was routinely achieved using scopolamine butylbromide injection. Sphincterotomy (EST) and Endoscopic papillary balloon dilatation (EPBD) can be choose accordingly. The laparoscopic cholecystectomy was subsequently performed as soon as technically feasible following the ERCP in one month.
| Study group | Role | What they receive |
|---|---|---|
| LCBDE group (single step) | Active comparator | Choledocholithiasis patient, after Laparoscopic Cholecystectomy (LC) to remove the gallbladder, Laparoscopic Common Bile Duct Exploration (LCBDE) was performed for removing the bile duct stone(s) in laparoscopy. Choledochoscope detection or cholangiograms should be chosen as a method of obtain stone clearance. T-tube was acceptable if needed. Receives: Procedure: Laparoscopy |
| ERCP group (sequential step) | Active comparator | Choledocholithiasis patient, Endoscopic Retrograde cholangiopancreatography (ERCP) was performed for removing the bile duct stone(s) in endoscopy prior to Laparoscopic Cholecystectomy (LC). Sphincterotomy (EST) and Endoscopic papillary balloon dilatation (EPBD) can be chosen accordingly. The laparoscopic cholecystectomy was subsequently performed as soon as technically feasible following the ERCP in one month. Receives: Procedure: Endoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Common bile duct stone recurrence
Stone was diagnosed by MRI or CT whenever be confirmed after 3 months after procedures.
Measured: Up to 5 years
Secondary outcomes (11)
The proportion of patients with all stones removed
Measured: Up to 8 hours
Operation time
For arm1 (LCBED): the whole process of the operation; for arm2 (LC+ERCP): the total of the two procedures, LC and ERCP
Measured: Up to 8 hours
Length of stay in hospital
Measured: Up to 60 days
The total hospitalization costs
Measured: Up to 60 days
Upper abdominal pain after each procedure by Numerical Rating Scale
Measured: Up to 60 days
Hemorrhage
Maintained positive fecal occult blood test appears or Hb decreased by 10g/l
Measured: Up to 60 days
Perforation
CT scan shows retroperitoneal space fluid or gas
Measured: Up to 7 days
Acute cholangitis
Intermittent chills and fever after procedures
Measured: Up to 5 years
Bile leakage
Any bile juice aspirated from the abdominal cavity after procedures
Measured: Up to 60 days
Stricture of the bile duct
Any stricture appears after the procedures
Measured: Up to 5 years
Number of Death connected with the procedures and complications
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2015 (estimated)
- Study start1 Sep 2015
- Primary completion1 Jan 2024
- Study completion1 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for CholedocholithiasisStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hepatopancreatobiliary Surgery Institute of Gansu Province
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xun Li, Hepatopancreatobiliary Surgery Institute of Gansu Province
- Investigators
- Xun Li, M.D., Ph.D., Principal investigator, Hepatopancreatobiliary Surgery Institute of Gansu Province
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02515474
- Sponsor's protocol ID
- Complications of LCBED vs ERCP
- Status last verified
- Jan 2024
- First submitted
- 30 Jul 2015
- Last updated
- 5 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Cuschieri A, Lezoche E, Morino M, Croce E, Lacy A, Toouli J, Faggioni A, Ribeiro VM, Jakimowicz J, Visa J, Hanna GB. E.A.E.S. multicenter prospective randomized trial comparing two-stage vs single-stage management of patients with gallstone disease and ductal calculi. Surg Endosc. 1999 Oct;13(10):952-7. doi: 10.1007/s004649901145.
PubMed 10526025Goh ES, Liang B, Fook-Chong S, Shahidah N, Soon SS, Yap S, Leong B, Gan HN, Foo D, Tham LP, Charles R, Ong ME. Effect of location of out-of-hospital cardiac arrest on survival outcomes. Ann Acad Med Singap. 2013 Sep;42(9):437-44.
PubMed 24162318Koc B, Karahan S, Adas G, Tutal F, Guven H, Ozsoy A. Comparison of laparoscopic common bile duct exploration and endoscopic retrograde cholangiopancreatography plus laparoscopic cholecystectomy for choledocholithiasis: a prospective randomized study. Am J Surg. 2013 Oct;206(4):457-63. doi: 10.1016/j.amjsurg.2013.02.004. Epub 2013 Jul 17.
PubMed 23871320Bansal VK, Misra MC, Garg P, Prabhu M. A prospective randomized trial comparing two-stage versus single-stage management of patients with gallstone disease and common bile duct stones. Surg Endosc. 2010 Aug;24(8):1986-9. doi: 10.1007/s00464-010-0891-7. Epub 2010 Feb 5.
PubMed 20135172Jeon TY, Han ME, Lee YW, Lee YS, Kim GH, Song GA, Hur GY, Kim JY, Kim HJ, Yoon S, Baek SY, Kim BS, Kim JB, Oh SO. Overexpression of stathmin1 in the diffuse type of gastric cancer and its roles in proliferation and migration of gastric cancer cells. Br J Cancer. 2010 Feb 16;102(4):710-8. doi: 10.1038/sj.bjc.6605537. Epub 2010 Jan 19.
PubMed 20087351Noble H, Tranter S, Chesworth T, Norton S, Thompson M. A randomized, clinical trial to compare endoscopic sphincterotomy and subsequent laparoscopic cholecystectomy with primary laparoscopic bile duct exploration during cholecystectomy in higher risk patients with choledocholithiasis. J Laparoendosc Adv Surg Tech A. 2009 Dec;19(6):713-20. doi: 10.1089/lap.2008.0428.
PubMed 19792866Sgourakis G, Karaliotas K. Laparoscopic common bile duct exploration and cholecystectomy versus endoscopic stone extraction and laparoscopic cholecystectomy for choledocholithiasis. A prospective randomized study. Minerva Chir. 2002 Aug;57(4):467-74.
PubMed 12145577
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Long Term Comparison of Laparoscopic Common Bile Duct Exploration and Cholecystectomy Versus Sequential ERCP Followed by Cholecystectomy for Choledocholithiasis: a Multicenter Prospected Non-randomized Controlled Study
- ClinicalTrials.gov ID
- NCT02515474
- Acronym / sponsor ID
- Complications of LCBED vs ERCP
- Conditions
- Choledocholithiasis
- Keywords
- Cholangiopancreatography, Endoscopic, Common bile duct, Complication, Recurrence, Laparoscopic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Hepatopancreatobiliary Surgery Institute of Gansu ProvinceUniversity, hospital or other
- Study start
- 1 Sep 2015 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 4 Aug 2015 (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.
Protection of Oddi's sphincter remains a huge argument especially in the long term complications like common bile duct stone recurrence or cholangitis after ERCP, which determined to destroy the sphincter of Oddi. The purpose of this study is to compare the long-term outcomes of ERCP sequential LC versus LCBDE for choledocholithiasis.
Detailed description
Cholelithiasis, a common etiology factor responsible for abdominal pain, is highly prevalent worldwide. According to data from general investigation, the morbidity of cholelithiasis differs from 2.36% to 42% in different areas, and about 5% to 29% (average 18%) of all cholelithiasis cases have both gallbladder stone and common bile duct stone. In the population with age above 70 years old, 30% of which suffers from gallbladder stone in China. A causal link between the development of gallbladder stone and common bile duct stone is that 10% to 15% of gallstone patients have high potential to develop secondary common bile duct stone. In 1987, the laparoscopic cholecystectomy (LC) came into being as a revolutionary surgical method. With minimally invasive effect and high safety, LC was soon accepted as a 'Golden standard' for the treatment of gallbladder stone. Endoscopic sphincterotomy (EST) was firstly reported by Kawai and Classen in 1970. As of now, the combination of EST with other endoscopic techniques, such as basket extraction, balloon dilation and lithotripsy, have significantly improved the stone removal rate from 85% up to 90%, and ERCP has been considered as the optimal method in regard to CBD stone treatment. In 1991, the laparoscopic common bile duct exploration (LCBDE) which reflected the advantage of rigid scopes had risen to be a very promising minimally invasive alternative for the treatment of common bile duct (CBD) stone. Currently, there are mainly two kinds of minimally invasive treatments for choledocholithiasis, which refers to the "one-stage" laparoscopic method, LCBDE and the "sequential two-stage" method, ERCP followed by LC. Both methods are able to achieve the same therapeutic purpose. However, there has always been a controversy about the advantages and disadvantages due to lack of evidence from long-term follow-ups, especially the difference of long-term complications related to Oddi's sphincter functional status, which importantly refers to stone recurrence rates and cholangitis.
The potential long-term complications resulted from EST remains an issue now. It is believed that EST handles Oddi's sphincter stenosis, regurgitation cholangitis, and higher cholangiocarcinoma risks in a long run. By virtue of ERCP, multiple high stone clearance rates (87%~97%) were reported, but meanwhile high re-ERCP rates (around 25%) were also indicated because of stone residual, and whether great stone residual rates was linked to future stone recurrence and repeated cholangitis is not clear. Several randomized controlled trial (RCT) studies had compared ERCP plus LC and LCBDE, the results were similar to the aspects of stone removal rates, costs, and patient acceptance. However, the postoperative cholangitis rate of one single center study is quite different from another. Moreover, few studies have related the stone recurrence rate in the long term follow-up. Obviously, previous RCT studies were limited by few comparison of ERCP followed by LC versus LCBDE in long-term complications, especially stone recurrence and cholangitis. Therefore, this multicenter randomize control study is designed prospectively to compare the stone recurrence and cholangitis rates between ERCP plus LC and LCBDE which can reflects the valuable of Oddi's sphincter protection during the disease management, further dedicating the treatment of gallbladder and common duct stone.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LCBDE group (single step) | Active comparator | Procedure: LaparoscopyCholedocholithiasis patient, after Laparoscopic Cholecystectomy (LC) to remove the gallbladder, Laparoscopic Common Bile Duct Exploration (LCBDE) was performed for removing the bile duct stone(s) in laparoscopy. Choledochoscope detection or cholangiograms should be chosen as a method of obtain stone clearance. T-tube was acceptable if needed. |
| ERCP group (sequential step) | Active comparator | Procedure: EndoscopyCholedocholithiasis patient, Endoscopic Retrograde cholangiopancreatography (ERCP) was performed for removing the bile duct stone(s) in endoscopy prior to Laparoscopic Cholecystectomy (LC). Sphincterotomy (EST) and Endoscopic papillary balloon dilatation (EPBD) can be chosen accordingly. The laparoscopic cholecystectomy was subsequently performed as soon as technically feasible following the ERCP in one month. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18-65 years old
- Choledocholithiasis patient did not perform any operation
- Common bile duct stone less than 2cm in maximum diameter
Key exclusion criteria (10 listed)
- Unwillingness or inability to consent for the study
- Coagulation dysfunction (INR> 1.3) and low peripheral blood platelet count (<50×109 / L) or using anti-coagulation drugs
- Previous EST, EPBD or percutaneous transhepatic biliary drainage (PTBD)
- Prior surgery of Bismuth Ⅱ and Roux-en-Y
- Benign or malignant CBD stricture
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 |
|---|---|---|
| LaparoscopyAlso: Laparoscopic common bile duct exploration (LCBDE)After removing the gallbladder, Laparoscopic common bile duct exploration (LCBDE) was performed by one fulltime attending in laparoscopy in a routine fashion. Access from the opening of the anterior wall of common bile duct or from the dilated cystic duct was acceptable, removed stone(s) and irrigated the duct followed by choledochoscope detection simultaneously. Cholangiograms were also can be a alternative method to obtain stone clearance. If needed, all fluoroscopy was performed by the principal author in the presence of and concurrence with the ERCP endoscopist. Once the LCBDE was completed, the incision of the bile duct was sewed intermittently by absorbed threads, or ligated cystic duct. T-tube was acceptable if needed. | Procedure or surgery | LCBDE group (single step) |
| EndoscopyAlso: Endoscopic Retrograde cholangiopancreatography (ERCP)Initially endoscopic retrograde cholangiopancreatography (ERCP) was performed by a fulltime attending and concurrence of the principal author in endoscopy. Patients randomized to ERCP+ LC group were scheduled to undergo the endoscopic procedure using fluoroscopy in the endoscopy center under moderate sedation (principally intravenous midazolam and meperidine) prior to the intended laparoscopy. Gastric intestinal atony during ERCP was routinely achieved using scopolamine butylbromide injection. Sphincterotomy (EST) and Endoscopic papillary balloon dilatation (EPBD) can be choose accordingly. The laparoscopic cholecystectomy was subsequently performed as soon as technically feasible following the ERCP in one month. | Procedure or surgery | ERCP group (sequential step) |
Primary outcome
Common bile duct stone recurrence
Time frame: Up to 5 years
Stone was diagnosed by MRI or CT whenever be confirmed after 3 months after procedures.
11 secondary outcomes
The proportion of patients with all stones removed
Time frame: Up to 8 hours
Operation time
Time frame: Up to 8 hours
Length of stay in hospital
Time frame: Up to 60 days
The total hospitalization costs
Time frame: Up to 60 days
Upper abdominal pain after each procedure by Numerical Rating Scale
Time frame: Up to 60 days
Hemorrhage
Time frame: Up to 60 days
Perforation
Time frame: Up to 7 days
Acute cholangitis
Time frame: Up to 5 years
Bile leakage
Time frame: Up to 60 days
Stricture of the bile duct
Time frame: Up to 5 years
Number of Death connected with the procedures and complications
Time frame: Up to 5 years
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 5 Jan 2024.
- Background: PubMed 10526025Cuschieri A, Lezoche E, Morino M, Croce E, Lacy A, Toouli J, Faggioni A, Ribeiro VM, Jakimowicz J, Visa J, Hanna GB. E.A.E.S. multicenter prospective randomized trial comparing two-stage vs single-stage management of patients with gallstone disease and ductal calculi. Surg Endosc. 1999 Oct;13(10):952-7. doi: 10.1007/s004649901145.
- Background: PubMed 24162318Goh ES, Liang B, Fook-Chong S, Shahidah N, Soon SS, Yap S, Leong B, Gan HN, Foo D, Tham LP, Charles R, Ong ME. Effect of location of out-of-hospital cardiac arrest on survival outcomes. Ann Acad Med Singap. 2013 Sep;42(9):437-44.
- Background: PubMed 23871320Koc B, Karahan S, Adas G, Tutal F, Guven H, Ozsoy A. Comparison of laparoscopic common bile duct exploration and endoscopic retrograde cholangiopancreatography plus laparoscopic cholecystectomy for choledocholithiasis: a prospective randomized study. Am J Surg. 2013 Oct;206(4):457-63. doi: 10.1016/j.amjsurg.2013.02.004. Epub 2013 Jul 17.
- Background: PubMed 20135172Bansal VK, Misra MC, Garg P, Prabhu M. A prospective randomized trial comparing two-stage versus single-stage management of patients with gallstone disease and common bile duct stones. Surg Endosc. 2010 Aug;24(8):1986-9. doi: 10.1007/s00464-010-0891-7. Epub 2010 Feb 5.
- Background: PubMed 20087351Jeon TY, Han ME, Lee YW, Lee YS, Kim GH, Song GA, Hur GY, Kim JY, Kim HJ, Yoon S, Baek SY, Kim BS, Kim JB, Oh SO. Overexpression of stathmin1 in the diffuse type of gastric cancer and its roles in proliferation and migration of gastric cancer cells. Br J Cancer. 2010 Feb 16;102(4):710-8. doi: 10.1038/sj.bjc.6605537. Epub 2010 Jan 19.
- Background: PubMed 19792866Noble H, Tranter S, Chesworth T, Norton S, Thompson M. A randomized, clinical trial to compare endoscopic sphincterotomy and subsequent laparoscopic cholecystectomy with primary laparoscopic bile duct exploration during cholecystectomy in higher risk patients with choledocholithiasis. J Laparoendosc Adv Surg Tech A. 2009 Dec;19(6):713-20. doi: 10.1089/lap.2008.0428.
- Background: PubMed 12145577Sgourakis G, Karaliotas K. Laparoscopic common bile duct exploration and cholecystectomy versus endoscopic stone extraction and laparoscopic cholecystectomy for choledocholithiasis. A prospective randomized study. Minerva Chir. 2002 Aug;57(4):467-74.
- Individual participant dataSharing planned: No
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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.
Xun Li, M.D., Ph.D. principal investigator
Hepatopancreatobiliary Surgery Institute of Gansu Province
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopy and Endoscopy in people with Choledocholithiasis, run by Hepatopancreatobiliary Surgery Institute of Gansu Province at 12 sites 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 3 inclusion and 10 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 5 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites 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?
Common bile duct stone recurrence (time frame: Up to 5 years). 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 NCT02515474, which also lists 7 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 5 Jan 2024.