CholeclithiasisERCP/CBDENCT00807729
Randomized Trial of ERCP Then Laparoscopic Cholecystectomy vs. Laparoscopic Cholecystectomy Plus Laparoscopic Common Bile Duct Exploration in Patients With Likely Choledocholithiasis
A study testing ERCP and LapCBDE in people with Choleclithiasis and Common Bile Duct Stones, run by University of California, San Francisco at 1 site in United States.
Trial summary
Objective: We compared outcome parameters for good-risk patients with classic signs, symptoms, laboratory and abdominal imaging features of cholecystolithiasis and choledocholithiasis randomized to either LC + LCBDE or ERCP/S + LC. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Choleclithiasis, Common Bile Duct Stones
- What is being tested?
- ERCP and LapCBDE
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 1997to Nov 2007
- 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 years
- Classic biliary-type pain
- Ultrasonographic demonstration of cholecystolithiasis
- Platelet count > 100,000 per mm³ and prothrombin time < 3 seconds of control
- American Society of Anesthesiology (ASA) risk grade I or II:
- Common bile duct diameter greater than 6 mm by ultrasound or computed tomography (CT) scan
- Intrahepatic duct dilation as determined by ultrasound or CT scan Serum bilirubin greater than 2mg/dl, alkaline phosphatase and/or lipase more than 1.5 times upper limit of normal within 48 hours of intended first pro
Who cannot join
- History of bleeding disorders, platelet count <100,000 per mm³ and/or prothrombin time >3 seconds over control
- Uremia as evidenced by a creatinine > 3 mg/dl and/or blood urea nitrogen > 50 mg/dl
- Ultrasonography or CT evidence of cirrhosis, intrahepatic gallbladder, liver mass or abscess, or periampullary neoplasm
- Insulin-dependent diabetes mellitus
- Multiple prior laparotomies
- Morbid obesity
- Clinical, radiologic and/or biochemical evidence of cirrhosis or portal vein thrombosis
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
San Francisco General Hospital
San Francisco, California, 94110
About this study
Official title: Prospective Randomized Trial of Laparoscopic Cholecystectomy Plus Laparoscopic Common Bile Duct Exploration (LC + LCBDE) Versus Endoscopic Retrograde Cholangiopancreatography Sphincterotomy Plus Laparoscopic Cholecystectomy (ERCP/S + LC) for Common Bile Duct Stone Disease
Objective: We compared outcome parameters for good-risk patients with classic signs, symptoms, laboratory and abdominal imaging features of cholecystolithiasis and choledocholithiasis randomized to either LC + LCBDE or ERCP/S + LC.
Design: Our study was a prospective trial conducted following written informed consent with randomization by the serially-numbered opaque envelope technique.
Read more
Setting: Our institution is an academic teaching hospital and the central receiving and trauma center for the City and County of San Francisco.
Patients: We randomized 122 patients (American Society of Anesthesiologists Grade I or II) meeting entry criteria. Ten of these patients, excluded from outcome analysis, were protocol violators having signed out of the hospital against medical advice before one of both procedures were completed.
Interventions: Treatment was pre-operative endoscopic retrograde cholangiopancreatography sphincterotomy (ERCP/S) followed by laparoscopic cholecystectomy (LC), or laparoscopic cholecystectomy plus laparoscopic common bile duct exploration (LC + LCBDE).
Main Outcome Measures: The primary outcome measure was efficacy of stone clearance from the common bile duct. Secondary endpoints were length of hospital stay, cost of index hospitalization, professional fees, hospital charges, morbidity and mortality, and patient acceptance and quality of life scores.
Read the detailed description
Objective: We compared outcome parameters for good-risk patients with classic signs, symptoms, laboratory and abdominal imaging features of cholecystolithiasis and choledocholithiasis randomized to either LC + LCBDE or ERCP/S + LC.
Design: Our study was a prospective trial conducted following written informed consent with randomization by the serially-numbered opaque envelope technique.
Setting: Our institution is an academic teaching hospital and the central receiving and trauma center for the City and County of San Francisco.
Patients: We randomized 122 patients (American Society of Anesthesiologists Grade I or II) meeting entry criteria. Ten of these patients, excluded from outcome analysis, were protocol violators having signed out of the hospital against medical advice before one of both procedures were completed.
Interventions: Treatment was pre-operative endoscopic retrograde cholangiopancreatography sphincterotomy (ERCP/S) followed by laparoscopic cholecystectomy (LC), or laparoscopic cholecystectomy plus laparoscopic common bile duct exploration (LC + LCBDE).
Main Outcome Measures: The primary outcome measure was efficacy of stone clearance from the common bile duct. Secondary endpoints were length of hospital stay, cost of index hospitalization, professional fees, hospital charges, morbidity and mortality, and patient acceptance and quality of life scores.
- Conditions
- Choleclithiasis, Common Bile Duct Stones
- Being tested
- ERCP, LapCBDE
- Keywords
- Laparoscopy, Endoscopic retrograde cholangiopancreatography, Sphincterotomy, Common bile duct stones, Laparoscoopic common bile duct exploration, Cost efficiency, Examination of efficacy, safety, cost of intervention for patients with choleclithiasis and likely common bile duct stones
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ERCPProcedure or surgery
Also called ERCP/ laparoscopic cholecystectomy
Endoscopic Retrograde Cholangiopancreatography Patients randomized to ERCP/S + LC were scheduled to undergo the endoscopic procedure using fluoroscopy (OEC Diasonics 9400) in the endoscopy suite under moderate sedation (principally intravenous midazolam and meperidine) prior to the intended laparoscopy. Duodenal atony during ERCP was routinely achieved using intravenout glucagon. If choledocholithiasis was detected or suspected at the time of ERCP, a sphincterotomy was undertaken so that gallstones could be extracted using a balloon catheter or retrieval basket. Small bowel gas was aspirated endoscopically as much as possible at the conclusion of the ERCP. The laparoscopic cholecystectomy was subsequently performed as soon as technically feasible (i.e. following abdominal gas decompression) following the ERCP
LapCBDEProcedure or surgery
Also called Laparoscopic common bile duct exploration
LC + LCBDE was performed in a routine fashion by one fulltime faculty member (SJR) with fellowship training in laparoscopy. Cholangiograms were obtained fluoroscopically using the same make and model fluoroscope (OEC Diasonics 9400) as used in ERCP by antegrade contrast flushing through the cystic duct. All fluoroscopy was performed by the principal author (SJR) in the presence of and concurrence with the ERCP endoscopist (JPC). When stones were detected or suspected by cholangiography, transcystic exploration was undertaken by balloon or basket with associated balloon dilation of the sphincter of Oddi A completion cholangiogram was obtained to confirm that all stones were removed. Once the LCBDE was completed, the cystic duct was ligated and the gallbladder removed.
| Study group | Role | What they receive |
|---|---|---|
| ERCP | Active comparator | All ERCP's were performed by one of the authors (JPC), a fulltime faculty member and gastroenterology fellowship instructor in the presence and concurrence of the principal author/ surgeon (SJR). Patients randomized to ERCP/S + LC were scheduled to undergo the endoscopic procedure using fluoroscopy (OEC Diasonics 9400) in the endoscopy suite under moderate sedation (principally intravenous midazolam and meperidine) prior to the intended laparoscopy. Duodenal atony during ERCP was routinely achieved using intravenout glucagon. The laparoscopic cholecystectomy was subsequently performed as soon as technically feasible (i.e. following abdominal gas decompression) following the ERCP Receives: Procedure: ERCP |
| Lap CBDE | Active comparator | LC + LCBDE was performed in a routine fashion by one fulltime faculty member (SJR) with fellowship training in laparoscopy. Cholangiograms were obtained fluoroscopically using the same make and model fluoroscope (OEC Diasonics 9400) as used in ERCP by antegrade contrast flushing through the cystic duct. All fluoroscopy was performed by the principal author (SJR) in the presence of and concurrence with the ERCP endoscopist (JPC). When stones were detected or suspected by cholangiography, transcystic exploration was undertaken by balloon or basket with associated balloon dilation of the sphincter of Oddi A completion cholangiogram was obtained to confirm that all stones were removed. Once the LCBDE was completed, the cystic duct was ligated and the gallbladder removed. Receives: Procedure: LapCBDE |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint was the efficacy of common bile duct stone clearance.
Measured: Hospital admmission
Secondary outcomes (1)
Secondary endpoints were length of hospital stay, total cost of index hospitalization, professional fee charges, hospital charges, morbidity and mortality, and patient acceptance and quality of life scores.
Measured: Hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2008 (estimated)
- Study startJan 1997
- Primary completionJul 2003
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CholeclithiasisStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00807729
- Sponsor's protocol ID
- H9437-10261-12
- Other IDs
- K08DK002607
- Acronym
- ERCP/CBDE
- Status last verified
- Sep 2009
- First submitted
- 10 Dec 2008
- Last updated
- 3 Sep 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Rogers SJ, Cello JP, Horn JK, Siperstein AE, Schecter WP, Campbell AR, Mackersie RC, Rodas A, Kreuwel HT, Harris HW. Prospective randomized trial of LC+LCBDE vs ERCP/S+LC for common bile duct stone disease. Arch Surg. 2010 Jan;145(1):28-33. doi: 10.1001/archsurg.2009.226.
PubMed 20083751
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Trial of Laparoscopic Cholecystectomy Plus Laparoscopic Common Bile Duct Exploration (LC + LCBDE) Versus Endoscopic Retrograde Cholangiopancreatography Sphincterotomy Plus Laparoscopic Cholecystectomy (ERCP/S + LC) for Common Bile Duct Stone Disease
- ClinicalTrials.gov ID
- NCT00807729
- Acronym / sponsor ID
- ERCP/CBDE / H9437-10261-12
- Conditions
- Choleclithiasis, Common Bile Duct Stones
- Keywords
- Laparoscopy, Endoscopic retrograde cholangiopancreatography, Sphincterotomy, Common bile duct stones, Laparoscoopic common bile duct exploration, Cost efficiency, Examination of efficacy, safety, cost of intervention for patients with choleclithiasis and likely common bile duct stones
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Jan 1997
- Primary completion
- Jul 2003 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 12 Dec 2008 (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.
Objective: We compared outcome parameters for good-risk patients with classic signs, symptoms, laboratory and abdominal imaging features of cholecystolithiasis and choledocholithiasis randomized to either LC + LCBDE or ERCP/S + LC.
Design: Our study was a prospective trial conducted following written informed consent with randomization by the serially-numbered opaque envelope technique.
Setting: Our institution is an academic teaching hospital and the central receiving and trauma center for the City and County of San Francisco.
Patients: We randomized 122 patients (American Society of Anesthesiologists Grade I or II) meeting entry criteria. Ten of these patients, excluded from outcome analysis, were protocol violators having signed out of the hospital against medical advice before one of both procedures were completed.
Interventions: Treatment was pre-operative endoscopic retrograde cholangiopancreatography sphincterotomy (ERCP/S) followed by laparoscopic cholecystectomy (LC), or laparoscopic cholecystectomy plus laparoscopic common bile duct exploration (LC + LCBDE).
Main Outcome Measures: The primary outcome measure was efficacy of stone clearance from the common bile duct. Secondary endpoints were length of hospital stay, cost of index hospitalization, professional fees, hospital charges, morbidity and mortality, and patient acceptance and quality of life scores.
Detailed description
Objective: We compared outcome parameters for good-risk patients with classic signs, symptoms, laboratory and abdominal imaging features of cholecystolithiasis and choledocholithiasis randomized to either LC + LCBDE or ERCP/S + LC.
Design: Our study was a prospective trial conducted following written informed consent with randomization by the serially-numbered opaque envelope technique.
Setting: Our institution is an academic teaching hospital and the central receiving and trauma center for the City and County of San Francisco.
Patients: We randomized 122 patients (American Society of Anesthesiologists Grade I or II) meeting entry criteria. Ten of these patients, excluded from outcome analysis, were protocol violators having signed out of the hospital against medical advice before one of both procedures were completed.
Interventions: Treatment was pre-operative endoscopic retrograde cholangiopancreatography sphincterotomy (ERCP/S) followed by laparoscopic cholecystectomy (LC), or laparoscopic cholecystectomy plus laparoscopic common bile duct exploration (LC + LCBDE).
Main Outcome Measures: The primary outcome measure was efficacy of stone clearance from the common bile duct. Secondary endpoints were length of hospital stay, cost of index hospitalization, professional fees, hospital charges, morbidity and mortality, and patient acceptance and quality of life scores.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ERCP | Active comparator | Procedure: ERCPAll ERCP's were performed by one of the authors (JPC), a fulltime faculty member and gastroenterology fellowship instructor in the presence and concurrence of the principal author/ surgeon (SJR). Patients randomized to ERCP/S + LC were scheduled to undergo the endoscopic procedure using fluoroscopy (OEC Diasonics 9400) in the endoscopy suite under moderate sedation (principally intravenous midazolam and meperidine) prior to the intended laparoscopy. Duodenal atony during ERCP was routinely achieved using intravenout glucagon. The laparoscopic cholecystectomy was subsequently performed as soon as technically feasible (i.e. following abdominal gas decompression) following the ERCP |
| Lap CBDE | Active comparator | Procedure: LapCBDELC + LCBDE was performed in a routine fashion by one fulltime faculty member (SJR) with fellowship training in laparoscopy. Cholangiograms were obtained fluoroscopically using the same make and model fluoroscope (OEC Diasonics 9400) as used in ERCP by antegrade contrast flushing through the cystic duct. All fluoroscopy was performed by the principal author (SJR) in the presence of and concurrence with the ERCP endoscopist (JPC). When stones were detected or suspected by cholangiography, transcystic exploration was undertaken by balloon or basket with associated balloon dilation of the sphincter of Oddi A completion cholangiogram was obtained to confirm that all stones were removed. Once the LCBDE was completed, the cystic duct was ligated and the gallbladder removed. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age > 18 years
- Classic biliary-type pain
- Ultrasonographic demonstration of cholecystolithiasis
- Platelet count > 100,000 per mm³ and prothrombin time < 3 seconds of control
- American Society of Anesthesiology (ASA) risk grade I or II:
Key exclusion criteria (8 listed)
- History of bleeding disorders, platelet count <100,000 per mm³ and/or prothrombin time >3 seconds over control
- Uremia as evidenced by a creatinine > 3 mg/dl and/or blood urea nitrogen > 50 mg/dl
- Ultrasonography or CT evidence of cirrhosis, intrahepatic gallbladder, liver mass or abscess, or periampullary neoplasm
- Insulin-dependent diabetes mellitus
- Multiple prior laparotomies
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 |
|---|---|---|
| ERCPAlso: ERCP/ laparoscopic cholecystectomyEndoscopic Retrograde Cholangiopancreatography Patients randomized to ERCP/S + LC were scheduled to undergo the endoscopic procedure using fluoroscopy (OEC Diasonics 9400) in the endoscopy suite under moderate sedation (principally intravenous midazolam and meperidine) prior to the intended laparoscopy. Duodenal atony during ERCP was routinely achieved using intravenout glucagon. If choledocholithiasis was detected or suspected at the time of ERCP, a sphincterotomy was undertaken so that gallstones could be extracted using a balloon catheter or retrieval basket. Small bowel gas was aspirated endoscopically as much as possible at the conclusion of the ERCP. The laparoscopic cholecystectomy was subsequently performed as soon as technically feasible (i.e. following abdominal gas decompression) following the ERCP | Procedure or surgery | ERCP |
| LapCBDEAlso: Laparoscopic common bile duct explorationLC + LCBDE was performed in a routine fashion by one fulltime faculty member (SJR) with fellowship training in laparoscopy. Cholangiograms were obtained fluoroscopically using the same make and model fluoroscope (OEC Diasonics 9400) as used in ERCP by antegrade contrast flushing through the cystic duct. All fluoroscopy was performed by the principal author (SJR) in the presence of and concurrence with the ERCP endoscopist (JPC). When stones were detected or suspected by cholangiography, transcystic exploration was undertaken by balloon or basket with associated balloon dilation of the sphincter of Oddi A completion cholangiogram was obtained to confirm that all stones were removed. Once the LCBDE was completed, the cystic duct was ligated and the gallbladder removed. | Procedure or surgery | Lap CBDE |
Primary outcome
The primary endpoint was the efficacy of common bile duct stone clearance.
Time frame: Hospital admmission
1 secondary outcome
Secondary endpoints were length of hospital stay, total cost of index hospitalization, professional fee charges, hospital charges, morbidity and mortality, and patient acceptance and quality of life scores.
Time frame: Hospitalization
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 3 Sep 2009.
- Derived from this study: PubMed 20083751Rogers SJ, Cello JP, Horn JK, Siperstein AE, Schecter WP, Campbell AR, Mackersie RC, Rodas A, Kreuwel HT, Harris HW. Prospective randomized trial of LC+LCBDE vs ERCP/S+LC for common bile duct stone disease. Arch Surg. 2010 Jan;145(1):28-33. doi: 10.1001/archsurg.2009.226.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ERCP and LapCBDE in people with Choleclithiasis and Common Bile Duct Stones, run by University of California, San Francisco at 1 site in United States.
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 8 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 3 Sep 2009. 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 United States. 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?
The primary endpoint was the efficacy of common bile duct stone clearance. (time frame: Hospital admmission). 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 NCT00807729, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2009.