Choledocholithiasis With Cholecystitis With ObstructionNCT04213092
Single Setting ERCP and Laparoscopic Cholecystectomy is a Safe Procedure in Patients With Cholecysto-Choledocholithiasis
An observational study of Choledocholithiasis With Cholecystitis With Obstruction and Choledocholithiasis With Acute and Chronic Cholecystitis, run by Lumbini Medical College.
Trial summary
The ideal management of cholecysto-choledocholithiasis is an open cholecystectomy (OC) with the common bile duct (CBD) exploration worldwide. The single setting 2-stage approach- endoscopic retrograde cholangiopancreatography (ERCP), endoscopic sphincterotomy (EST), and CBD clearance followed by laparoscopic… Read more about this study
- Who is it for?
- Ages 13 to 85 years
- Conditions the study is for
- Choledocholithiasis With Cholecystitis With Obstruction, Choledocholithiasis With Acute and Chronic Cholecystitis, Cholelithiasis With Acute and Chronic Cholecystitis
- What is being tested?
- ERCP+LC and OC+CBD
- Type of treatment
- Surgery or procedure
- How many people
- 160 participants
- Where
- No sites listed yet
- Study dates
- Nov 2012to Oct 2015
- 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 13 to 85 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study was carried out in a peripheral setting hospital located in a remote city of Nepal-"Palpa" and the population is heterogeneous in terms of age.
Who may be able to join
- All the sonological proven cases of choledocholithiasis with cholelithiasis.
- CBD diameter <2cm.
- Age >13 yrs.
Who cannot join
- Clinical, radiologic, or biochemical evidence of cholangitis and pancreatitis.
- Evidence of cirrhosis, intrahepatic gallbladder, liver mass or abscess, neoplasm, Suppurative or necrotizing cholecystitis, gall bladder empyema, or perforation, Pregnancy.
- Age >85 yrs.
About this study
Official title: "Single Setting ERCP and Laparoscopic Cholecystectomy is a Safe Procedure in Patients With Cholecysto-Choledocholithiasis: A Prospective Study in a Peripheral-Level Hospital"
The ideal management of cholecysto-choledocholithiasis is an open cholecystectomy (OC) with the common bile duct (CBD) exploration worldwide. The single setting 2-stage approach- endoscopic retrograde cholangiopancreatography (ERCP), endoscopic sphincterotomy (EST), and CBD clearance followed by laparoscopic cholecystectomy (LC) offers an advantage, mainly by reducing the hospital stay, the cost, and the morbidity. Investigators did a prospective study in patients admitted for the management of the cholecysto-choledocholithiasis in the Department of Surgery at the Lumbini Medical College and Teaching Hospital from November 2012- October 2015. They underwent 2-stage ERCP+LC in a single setting and investigators compared them with 2-stage OC+CBD exploration in a single setting approach. The patients with the open procedure were the investigator's control groups. All the included cases in the study were elective.
Read the detailed description
This was a prospective study done on patients admitted for management of the cholecysto-choledocholithiasis in the Department of Surgery at the Lumbini Medical College and Teaching Hospital from November 2012 - October 2015. This is a peripheral setting hospital located in a remote city of Nepal-"Palpa". The study was approved by the institutional ethical committee- "IRC of Lumbini Medical College and Teaching Hospital" and written consent was obtained from all of the patients. A comprehensive literature search published in English was done till 2019 using Hinari, PubMed, Cochrane Library, EMBASE, Web of Science, and ScienceDirect.
This is an interim analysis of 160 patients with 83 (51.9%) patients in ERCP+LC and 77 (48.1%) in open procedure (OC with CBD exploration) group respectively. The primary objective was to compare the single setting ERCP+LC with OC+CBD exploration and the secondary objectives were to study 1) the feasibility of the procedure, 2) detect the morbidity (cholangitis, pancreatitis, abdominal collection, and wound infection), 3) the length of stay, and ). The stone clearance respectively. The investigators defined their single-setting procedure as ERCP followed by LC. The patients from an open procedure group were those who underwent the procedure before our team was trained to carry out the ERCP. This open procedure group also included 10 patients who underwent open surgery due to unsuccessful ERCP. And finally, investigators compared ERCP+LC group with those who underwent the open procedure. The inclusion and exclusion criteria for ERCP+LC and open procedure are shown in Table 1 and Table 2 respectively.
After being informed about the related therapeutic maneuver, the patients were chosen for the sequence of endoscopic procedures and LC. And, the unsuccessful patients underwent through the OC with CBD exploration along with choledochoscopy. General anesthesia with nasal endotracheal intubation was done in all the patients. Antibiotic prophylaxis was given according to the standard recommendation for cholecystectomy.18 The ERCP procedure was performed with the patients in the prone position. A duodenoscope (TJF160R, Fujinon, Japan) was inserted into the second segment of duodenum via the mouth. A cholangiogram was carried out using C-arm X-ray (SIEMENS) and an EST was performed to extract the CBD stones. The stones were removed by basket or balloon catheter. Stones larger than 10 mm were removed using a mechanical lithotripter. Following ERCP, care was taken to remove all the gas from the stomach to facilitate LC. The patients were then placed in the reverse Trendelenburg position. LC was performed using the four trocar technique. A sub-hepatic drain was positioned if there was any concern about the possible bile leakage or bleeding in the postoperative period.
In cases of failed ERCP, the patients were placed in the supine position and OC with CBD explorations were performed in the same setting. A right subcostal incision was given for the open surgery. Cholecystectomy was performed ante-grade or retro-grade technique depending upon the anatomical variations of the gallbladder. CBD was opened below the opening of the cystic duct and stone clearances were done. To assure the stone clearances intraoperative choledochoscopies were performed. All the procedure viz. ERCP, LC, and open surgeries were performed by an experienced single surgeon and his team.
The statistical data were analyzed with a t-test, Pearson's χ2, Fisher's exact test, Mann Whitney's test, and Kruskal Wallis test using a statistical analysis program (SPSS 16), p <0.05 was considered statistically significant.
- Conditions
- Choledocholithiasis With Cholecystitis With Obstruction, Choledocholithiasis With Acute and Chronic Cholecystitis, Cholelithiasis With Acute and Chronic Cholecystitis
- Being tested
- ERCP+LC, OC+CBD
- Keywords
- Common bile duct stones, Endoscopic Retrograde Cholangiopancreatography, Laparoscopic Cholecystectomy, Open Cholecystectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ERCP+LCProcedure or surgery
Patients in this group underwent a single setting ERCP and Laparoscopic cholecystectomy.
OC+CBDProcedure or surgery
Patients in this group underwent a single setting open cholecystectomy and open CBD exploration.
| Study group | Role | What they receive |
|---|---|---|
| ERCP+LC | Patients in this group underwent 2-stage ERCP+LC in a single setting. And, it was compared with our control group Receives: Procedure: ERCP+LC | |
| OC+CBD | This group with 2-stage OC+CBD exploration in a single setting approach was taken as a control group. Receives: Procedure: OC+CBD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare ERCP+LC with OC+CBD exploration
To compare the single setting ERCP+LC with OC+CBD exploration and the Feasibility of the procedure at the peripheral setting hospital.
Measured: 7 days
Secondary outcomes (2)
Morbidity
Detect cholangitis, pancreatitis, abdominal collection, and wound infection respectively
Measured: 7 days
Length
The length of Hospital stay
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2019
- Study startNov 2012
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Choledocholithiasis With Cholecystitis With ObstructionStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lumbini Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, NabinPokharel, Lumbini Medical College
- Investigators
- Chet R Pant, MD, MPH, Study chair, Lumbini Medical College & Teaching Hospital Ltd, Kathmandu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04213092
- Sponsor's protocol ID
- IRC-LMC 01-H-015
- Status last verified
- Dec 2019
- First submitted
- 25 Dec 2019
- Last updated
- 2 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We can share our study IPD to interested researchers. Please email us at nabin.pokharel@gmail.com
Publications
European Association for the Study of the Liver (EASL). Electronic address: easloffice@easloffice.eu. EASL Clinical Practice Guidelines on the prevention, diagnosis and treatment of gallstones. J Hepatol. 2016 Jul;65(1):146-181. doi: 10.1016/j.jhep.2016.03.005. Epub 2016 Apr 13. No abstract available.
PubMed 27085810Zhu HY, Xu M, Shen HJ, Yang C, Li F, Li KW, Shi WJ, Ji F. A meta-analysis of single-stage versus two-stage management for concomitant gallstones and common bile duct stones. Clin Res Hepatol Gastroenterol. 2015 Oct;39(5):584-93. doi: 10.1016/j.clinre.2015.02.002. Epub 2015 Apr 27.
PubMed 25936687ASGE Standards of Practice Committee; Maple JT, Ikenberry SO, Anderson MA, Appalaneni V, Decker GA, Early D, Evans JA, Fanelli RD, Fisher D, Fisher L, Fukami N, Hwang JH, Jain R, Jue T, Khan K, Krinsky ML, Malpas P, Ben-Menachem T, Sharaf RN, Dominitz JA. The role of endoscopy in the management of choledocholithiasis. Gastrointest Endosc. 2011 Oct;74(4):731-44. doi: 10.1016/j.gie.2011.04.012. No abstract available.
PubMed 21951472Gurusamy KS, Giljaca V, Takwoingi Y, Higgie D, Poropat G, Stimac D, Davidson BR. Ultrasound versus liver function tests for diagnosis of common bile duct stones. Cochrane Database Syst Rev. 2015 Feb 26;2015(2):CD011548. doi: 10.1002/14651858.CD011548.
PubMed 25719223Miletic D, Uravic M, Mazur-Brbac M, Stimac D, Petranovic D, Sestan B. Role of magnetic resonance cholangiography in the diagnosis of bile duct lithiasis. World J Surg. 2006 Sep;30(9):1705-12. doi: 10.1007/s00268-005-0459-1.
PubMed 16850153Freitas ML, Bell RL, Duffy AJ. Choledocholithiasis: evolving standards for diagnosis and management. World J Gastroenterol. 2006 May 28;12(20):3162-7. doi: 10.3748/wjg.v12.i20.3162.
PubMed 16718834Lee A, Min SK, Park JJ, Lee HK. Laparoscopic common bile duct exploration for elderly patients: as a first treatment strategy for common bile duct stones. J Korean Surg Soc. 2011 Aug;81(2):128-33. doi: 10.4174/jkss.2011.81.2.128. Epub 2011 Aug 3.
PubMed 22066112Gurusamy KS, Giljaca V, Takwoingi Y, Higgie D, Poropat G, Stimac D, Davidson BR. Endoscopic retrograde cholangiopancreatography versus intraoperative cholangiography for diagnosis of common bile duct stones. Cochrane Database Syst Rev. 2015 Feb 26;2015(2):CD010339. doi: 10.1002/14651858.CD010339.pub2.
PubMed 25719222Gomez-Torres GA, Gonzalez-Hernandez J, Lopez-Lizarraga CR, Navarro-Muniz E, Ortega-Garcia OS, Bonnet-Lemus FM, Abarca-Rendon FM, De la Cerda-Trujillo LF. Intraoperative cholangiography versus magnetic resonance cholangiography in patients with mild acute biliary pancreatitis: A prospective study in a second-level hospital. Medicine (Baltimore). 2018 Nov;97(44):e12976. doi: 10.1097/MD.0000000000012976.
PubMed 30383648Alexakis N, Connor S. Meta-analysis of one- vs. two-stage laparoscopic/endoscopic management of common bile duct stones. HPB (Oxford). 2012 Apr;14(4):254-9. doi: 10.1111/j.1477-2574.2012.00439.x. Epub 2012 Feb 3.
PubMed 22404264ElGeidie AA, ElShobary MM, Naeem YM. Laparoscopic exploration versus intraoperative endoscopic sphincterotomy for common bile duct stones: a prospective randomized trial. Dig Surg. 2011;28(5-6):424-31. doi: 10.1159/000331470. Epub 2012 Jan 7.
PubMed 22236538
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Single Setting ERCP and Laparoscopic Cholecystectomy is a Safe Procedure in Patients With Cholecysto-Choledocholithiasis: A Prospective Study in a Peripheral-Level Hospital"
- ClinicalTrials.gov ID
- NCT04213092
- Acronym / sponsor ID
- IRC-LMC 01-H-015
- Conditions
- Choledocholithiasis With Cholecystitis With Obstruction, Choledocholithiasis With Acute and Chronic Cholecystitis, Cholelithiasis With Acute and Chronic Cholecystitis
- Keywords
- Common bile duct stones, Endoscopic Retrograde Cholangiopancreatography, Laparoscopic Cholecystectomy, Open Cholecystectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Lumbini Medical CollegeUniversity, hospital or other
- Study start
- Nov 2012 (actual)
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 30 Dec 2019 (actual)
- 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 ideal management of cholecysto-choledocholithiasis is an open cholecystectomy (OC) with the common bile duct (CBD) exploration worldwide. The single setting 2-stage approach- endoscopic retrograde cholangiopancreatography (ERCP), endoscopic sphincterotomy (EST), and CBD clearance followed by laparoscopic cholecystectomy (LC) offers an advantage, mainly by reducing the hospital stay, the cost, and the morbidity. Investigators did a prospective study in patients admitted for the management of the cholecysto-choledocholithiasis in the Department of Surgery at the Lumbini Medical College and Teaching Hospital from November 2012- October 2015. They underwent 2-stage ERCP+LC in a single setting and investigators compared them with 2-stage OC+CBD exploration in a single setting approach. The patients with the open procedure were the investigator's control groups. All the included cases in the study were elective.
Detailed description
This was a prospective study done on patients admitted for management of the cholecysto-choledocholithiasis in the Department of Surgery at the Lumbini Medical College and Teaching Hospital from November 2012 - October 2015. This is a peripheral setting hospital located in a remote city of Nepal-"Palpa". The study was approved by the institutional ethical committee- "IRC of Lumbini Medical College and Teaching Hospital" and written consent was obtained from all of the patients. A comprehensive literature search published in English was done till 2019 using Hinari, PubMed, Cochrane Library, EMBASE, Web of Science, and ScienceDirect.
This is an interim analysis of 160 patients with 83 (51.9%) patients in ERCP+LC and 77 (48.1%) in open procedure (OC with CBD exploration) group respectively. The primary objective was to compare the single setting ERCP+LC with OC+CBD exploration and the secondary objectives were to study 1) the feasibility of the procedure, 2) detect the morbidity (cholangitis, pancreatitis, abdominal collection, and wound infection), 3) the length of stay, and ). The stone clearance respectively. The investigators defined their single-setting procedure as ERCP followed by LC. The patients from an open procedure group were those who underwent the procedure before our team was trained to carry out the ERCP. This open procedure group also included 10 patients who underwent open surgery due to unsuccessful ERCP. And finally, investigators compared ERCP+LC group with those who underwent the open procedure. The inclusion and exclusion criteria for ERCP+LC and open procedure are shown in Table 1 and Table 2 respectively.
After being informed about the related therapeutic maneuver, the patients were chosen for the sequence of endoscopic procedures and LC. And, the unsuccessful patients underwent through the OC with CBD exploration along with choledochoscopy. General anesthesia with nasal endotracheal intubation was done in all the patients. Antibiotic prophylaxis was given according to the standard recommendation for cholecystectomy.18 The ERCP procedure was performed with the patients in the prone position. A duodenoscope (TJF160R, Fujinon, Japan) was inserted into the second segment of duodenum via the mouth. A cholangiogram was carried out using C-arm X-ray (SIEMENS) and an EST was performed to extract the CBD stones. The stones were removed by basket or balloon catheter. Stones larger than 10 mm were removed using a mechanical lithotripter. Following ERCP, care was taken to remove all the gas from the stomach to facilitate LC. The patients were then placed in the reverse Trendelenburg position. LC was performed using the four trocar technique. A sub-hepatic drain was positioned if there was any concern about the possible bile leakage or bleeding in the postoperative period.
In cases of failed ERCP, the patients were placed in the supine position and OC with CBD explorations were performed in the same setting. A right subcostal incision was given for the open surgery. Cholecystectomy was performed ante-grade or retro-grade technique depending upon the anatomical variations of the gallbladder. CBD was opened below the opening of the cystic duct and stone clearances were done. To assure the stone clearances intraoperative choledochoscopies were performed. All the procedure viz. ERCP, LC, and open surgeries were performed by an experienced single surgeon and his team.
The statistical data were analyzed with a t-test, Pearson's χ2, Fisher's exact test, Mann Whitney's test, and Kruskal Wallis test using a statistical analysis program (SPSS 16), p <0.05 was considered statistically significant.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ERCP+LC | – | Procedure: ERCP+LCPatients in this group underwent 2-stage ERCP+LC in a single setting. And, it was compared with our control group |
| OC+CBD | – | Procedure: OC+CBDThis group with 2-stage OC+CBD exploration in a single setting approach was taken as a control group. |
Who may qualify
- Ages
- 13 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study was carried out in a peripheral setting hospital located in a remote city of Nepal-"Palpa" and the population is heterogeneous in terms of age.
Key inclusion criteria (3 listed)
- All the sonological proven cases of choledocholithiasis with cholelithiasis.
- CBD diameter <2cm.
- Age >13 yrs.
Key exclusion criteria (3 listed)
- Clinical, radiologic, or biochemical evidence of cholangitis and pancreatitis.
- Evidence of cirrhosis, intrahepatic gallbladder, liver mass or abscess, neoplasm, Suppurative or necrotizing cholecystitis, gall bladder empyema, or perforation, Pregnancy.
- Age >85 yrs.
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 |
|---|---|---|
| ERCP+LCPatients in this group underwent a single setting ERCP and Laparoscopic cholecystectomy. | Procedure or surgery | ERCP+LC |
| OC+CBDPatients in this group underwent a single setting open cholecystectomy and open CBD exploration. | Procedure or surgery | OC+CBD |
Primary outcome
Compare ERCP+LC with OC+CBD exploration
Time frame: 7 days
To compare the single setting ERCP+LC with OC+CBD exploration and the Feasibility of the procedure at the peripheral setting hospital.
2 secondary outcomes
Morbidity
Time frame: 7 days
Length
Time frame: 7 days
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 2 Jan 2020.
- Background: PubMed 27085810European Association for the Study of the Liver (EASL). Electronic address: easloffice@easloffice.eu. EASL Clinical Practice Guidelines on the prevention, diagnosis and treatment of gallstones. J Hepatol. 2016 Jul;65(1):146-181. doi: 10.1016/j.jhep.2016.03.005. Epub 2016 Apr 13. No abstract available.
- Background: PubMed 25936687Zhu HY, Xu M, Shen HJ, Yang C, Li F, Li KW, Shi WJ, Ji F. A meta-analysis of single-stage versus two-stage management for concomitant gallstones and common bile duct stones. Clin Res Hepatol Gastroenterol. 2015 Oct;39(5):584-93. doi: 10.1016/j.clinre.2015.02.002. Epub 2015 Apr 27.
- Background: PubMed 21951472ASGE Standards of Practice Committee; Maple JT, Ikenberry SO, Anderson MA, Appalaneni V, Decker GA, Early D, Evans JA, Fanelli RD, Fisher D, Fisher L, Fukami N, Hwang JH, Jain R, Jue T, Khan K, Krinsky ML, Malpas P, Ben-Menachem T, Sharaf RN, Dominitz JA. The role of endoscopy in the management of choledocholithiasis. Gastrointest Endosc. 2011 Oct;74(4):731-44. doi: 10.1016/j.gie.2011.04.012. No abstract available.
- Background: PubMed 25719223Gurusamy KS, Giljaca V, Takwoingi Y, Higgie D, Poropat G, Stimac D, Davidson BR. Ultrasound versus liver function tests for diagnosis of common bile duct stones. Cochrane Database Syst Rev. 2015 Feb 26;2015(2):CD011548. doi: 10.1002/14651858.CD011548.
- Background: PubMed 16850153Miletic D, Uravic M, Mazur-Brbac M, Stimac D, Petranovic D, Sestan B. Role of magnetic resonance cholangiography in the diagnosis of bile duct lithiasis. World J Surg. 2006 Sep;30(9):1705-12. doi: 10.1007/s00268-005-0459-1.
- Background: PubMed 16718834Freitas ML, Bell RL, Duffy AJ. Choledocholithiasis: evolving standards for diagnosis and management. World J Gastroenterol. 2006 May 28;12(20):3162-7. doi: 10.3748/wjg.v12.i20.3162.
- Background: PubMed 22066112Lee A, Min SK, Park JJ, Lee HK. Laparoscopic common bile duct exploration for elderly patients: as a first treatment strategy for common bile duct stones. J Korean Surg Soc. 2011 Aug;81(2):128-33. doi: 10.4174/jkss.2011.81.2.128. Epub 2011 Aug 3.
- Background: PubMed 25719222Gurusamy KS, Giljaca V, Takwoingi Y, Higgie D, Poropat G, Stimac D, Davidson BR. Endoscopic retrograde cholangiopancreatography versus intraoperative cholangiography for diagnosis of common bile duct stones. Cochrane Database Syst Rev. 2015 Feb 26;2015(2):CD010339. doi: 10.1002/14651858.CD010339.pub2.
- Background: PubMed 30383648Gomez-Torres GA, Gonzalez-Hernandez J, Lopez-Lizarraga CR, Navarro-Muniz E, Ortega-Garcia OS, Bonnet-Lemus FM, Abarca-Rendon FM, De la Cerda-Trujillo LF. Intraoperative cholangiography versus magnetic resonance cholangiography in patients with mild acute biliary pancreatitis: A prospective study in a second-level hospital. Medicine (Baltimore). 2018 Nov;97(44):e12976. doi: 10.1097/MD.0000000000012976.
- Background: PubMed 22404264Alexakis N, Connor S. Meta-analysis of one- vs. two-stage laparoscopic/endoscopic management of common bile duct stones. HPB (Oxford). 2012 Apr;14(4):254-9. doi: 10.1111/j.1477-2574.2012.00439.x. Epub 2012 Feb 3.
- Background: PubMed 22236538ElGeidie AA, ElShobary MM, Naeem YM. Laparoscopic exploration versus intraoperative endoscopic sphincterotomy for common bile duct stones: a prospective randomized trial. Dig Surg. 2011;28(5-6):424-31. doi: 10.1159/000331470. Epub 2012 Jan 7.
- Individual participant dataSharing planned: Yes. We can share our study IPD to interested researchers. Please email us at nabin.pokharel@gmail.com
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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.
Chet R Pant, MD, MPH study chair
Lumbini Medical College & Teaching Hospital Ltd, Kathmandu University
Questions about this trial
What is this clinical trial studying?
An observational study of Choledocholithiasis With Cholecystitis With Obstruction and Choledocholithiasis With Acute and Chronic Cholecystitis, run by Lumbini Medical College.
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 3 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 2 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Compare ERCP+LC with OC+CBD exploration (time frame: 7 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 NCT04213092, which also lists 11 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 2 Jan 2020.