CholelithiasisCCK firstNCT01492790
Cholecystectomy First vs Sequential Common Bile Duct Imaging + Cholecystectomy
A study testing Emergency cholecystectomy first and Sequential common bile duct imaging/cholecystectomy in people with Cholelithiasis and Cholecystitis, run by University Hospital, Geneva at 1 site in Switzerland.
Trial summary
The purpose of this study is to evaluate if cholecystectomy first (studied group) versus sequential common bile duct imaging/cholecystectomy (control group) result in a decrease of hospital stay, morbidity/mortality and costs in the management of patients with a suspicion of gallstone migration. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Cholelithiasis, Cholecystitis
- What is being tested?
- Emergency cholecystectomy first and Sequential common bile duct imaging/cholecystectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jun 2011to Aug 2013
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients must have a clinical diagnosis of gallstone migration, defined as right upper quadrant or epigastric abdominal pain and abnormal liver function tests (increase of at least two common hepatic parameters [AST, ALT, alkaline phosphatase, gGT and/or bilirubin], with one of them being either AST or ALT with a value at least two times higher than the norm) with a reasonable exclusion of other common differential diagnoses
- Patients will be included regardless the presence of an associated cholecystitis, defined as right upper quadrant abdominal pain, radiological signs of cholecystitis (including radiological Murphy sign and/or thickened gallbladder wall and/or free abdominal fluid around the gallbladder) and signs of infection (including fever, increased CRP or white blood cell count)
- Age ≥ 16 years
Who cannot join
- Presence of CBD stone on CT or US performed on admission (which will require ERCP exploration prior to surgery)
- Associated radiologically proven gallstone pancreatitis
- Associated cholangitis
- Medical conditions preventing surgery such as acute stroke, acute coronary syndrome, severe cardiac failure (NYHA class IV and/or respiratory failure with SpO2 < 85% with room air and/or LVEF < 35%), severe COPD with VEMS < 30 % of predicted value
- Medical conditions preventing informed consent
- Patients with contraindications to MRI (MRI-incompatible electronic devices [e.g. pacemakers], implants or prostheses, vascular clips less than 2 weeks, severe claustrophobia) and to EUS/ERCP (surgery with gastric diversion, severe cardiac dysfunction)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Randomized Study Comparing Emergency Cholecystectomy First Versus Sequential Common Bile Duct Imaging/Cholecystectomy for the Management of Gallstone Migration
The purpose of this study is to evaluate if cholecystectomy first (studied group) versus sequential common bile duct imaging/cholecystectomy (control group) result in a decrease of hospital stay, morbidity/mortality and costs in the management of patients with a suspicion of gallstone migration.
Read the detailed description
Emergency cholecystectomy is nowadays an accepted surgical procedure routinely performed worldwide. The main indications include acute cholecystitis, cholangitis and gallstone migration. Abnormal liver function tests upon admission and suspicion for accompanying common bile duct (CBD) stone can delay the surgical management due to the need for further investigations and/or therapeutic maneuvers. These procedures include magnetic resonance cholangio-pancreatography (MRCP), endoscopic ultrasound (EUS) and endoscopic retrograde cholangio-pancreatography (ERCP).
While useful to detect or exclude potential CBD stones, these procedures include inherent risks, delay the surgical treatment, extend hospital stay and as a result, increase the overall medical costs. They can also potentially increase the morbidity and/or mortality by delaying emergency cholecystectomy (due to the presence of more local inflammation and adherence). Finally, more and more centers perform systematic intra-operative cholangiogram during cholecystectomies (laparoscopic or open), which allow an accurate assessment of the CBD and potentially lead to its subsequent exploration (endoscopic or surgical).
In this study, the investigators will assess the following hypotheses:
- Patients with a SUSPICION of gallstone migration (with or without associated cholecystitis) should undergo emergency cholecystectomy with intra-operative cholangiogram (IOC) first
- "Cholecystectomy first" strategy will decrease both the length of hospital stay and the morbidity/mortality by decreasing the number of unnecessary EUS, MRCP and ERCP and therefore decreasing the overall number of their complications, as well as decreasing the complications related to delayed cholecystectomy (increased adherences due to inflammation, especially in case of associated cholecystitis, which increase the risk of bleeding, CBD lesion, duodenal lesion, gastric lesion, colon lesion, gallbladder perforation and intra-abdominal gallstones spillage with potential
- Conditions
- Cholelithiasis, Cholecystitis
- Being tested
- Emergency cholecystectomy first, Sequential common bile duct imaging/cholecystectomy
- Medical subject headings
- Cholelithiasis, Cholecystitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emergency cholecystectomy firstProcedure or surgery
The intervention is an emergency cholecystectomy without prior common bile duct imaging
Sequential common bile duct imaging/cholecystectomyProcedure or surgery
This intervention is a common bile duct imaging modality and, if needed, ERCP first followed in the same hospital stay by a cholecystectomy
| Study group | Role | What they receive |
|---|---|---|
| Cholecystectomy first | Experimental | Patients enrolled in this arm will undergo emergency cholecystectomy first without any common bile duct imaging Receives: Procedure: Emergency cholecystectomy first |
| Sequential common bile duct imaging/cholecystectomy | Active comparator | Patients enrolled in this arm will undergo common bile duct imaging and, if needed, ERCP first followed by emergency cholecystectomy Receives: Procedure: Sequential common bile duct imaging/cholecystectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital stay [days]
We will evaluate if our "new treatment" arm will have a decreased hospital stay. We do not expect patients to stay more than 30 days.
Measured: 0 - 30 days
Secondary outcomes (2)
Morbidity
We will follow-up patients until 6 months after their operation (cholecystectomy) and compare if there is any statistically significant difference between the two arms of the study in terms of morbidity.
Measured: 6 months
Mortality
We will follow-up patients until 6 months after their operation (cholecystectomy) and compare if there is any statistically significant difference between the two arms of the study in terms of mortality.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2011 (estimated)
- Study startJun 2011
- Primary completionFeb 2013
- Study completionAug 2013
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 CholelithiasisStudies 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
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pouya Iranmanesh, University Hospital, Geneva
- Investigators
- Pouya Iranmanesh, MD, Principal investigator, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01492790
- Sponsor's protocol ID
- CER 11-045 (NAC 11-012)
- Acronym
- CCK first
- Status last verified
- Aug 2013
- First submitted
- 13 Dec 2011
- Last updated
- 13 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Iranmanesh P, Frossard JL, Mugnier-Konrad B, Morel P, Majno P, Nguyen-Tang T, Berney T, Mentha G, Toso C. Initial cholecystectomy vs sequential common duct endoscopic assessment and subsequent cholecystectomy for suspected gallstone migration: a randomized clinical trial. JAMA. 2014 Jul;312(2):137-44. doi: 10.1001/jama.2014.7587.
PubMed 25005650
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Randomized Study Comparing Emergency Cholecystectomy First Versus Sequential Common Bile Duct Imaging/Cholecystectomy for the Management of Gallstone Migration
- ClinicalTrials.gov ID
- NCT01492790
- Acronym / sponsor ID
- CCK first / CER 11-045 (NAC 11-012)
- Conditions
- Cholelithiasis, Cholecystitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Feb 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 15 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate if cholecystectomy first (studied group) versus sequential common bile duct imaging/cholecystectomy (control group) result in a decrease of hospital stay, morbidity/mortality and costs in the management of patients with a suspicion of gallstone migration.
Detailed description
Emergency cholecystectomy is nowadays an accepted surgical procedure routinely performed worldwide. The main indications include acute cholecystitis, cholangitis and gallstone migration. Abnormal liver function tests upon admission and suspicion for accompanying common bile duct (CBD) stone can delay the surgical management due to the need for further investigations and/or therapeutic maneuvers. These procedures include magnetic resonance cholangio-pancreatography (MRCP), endoscopic ultrasound (EUS) and endoscopic retrograde cholangio-pancreatography (ERCP).
While useful to detect or exclude potential CBD stones, these procedures include inherent risks, delay the surgical treatment, extend hospital stay and as a result, increase the overall medical costs. They can also potentially increase the morbidity and/or mortality by delaying emergency cholecystectomy (due to the presence of more local inflammation and adherence). Finally, more and more centers perform systematic intra-operative cholangiogram during cholecystectomies (laparoscopic or open), which allow an accurate assessment of the CBD and potentially lead to its subsequent exploration (endoscopic or surgical).
In this study, the investigators will assess the following hypotheses:
- Patients with a SUSPICION of gallstone migration (with or without associated cholecystitis) should undergo emergency cholecystectomy with intra-operative cholangiogram (IOC) first
- "Cholecystectomy first" strategy will decrease both the length of hospital stay and the morbidity/mortality by decreasing the number of unnecessary EUS, MRCP and ERCP and therefore decreasing the overall number of their complications, as well as decreasing the complications related to delayed cholecystectomy (increased adherences due to inflammation, especially in case of associated cholecystitis, which increase the risk of bleeding, CBD lesion, duodenal lesion, gastric lesion, colon lesion, gallbladder perforation and intra-abdominal gallstones spillage with potential
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cholecystectomy first | Experimental | Procedure: Emergency cholecystectomy firstPatients enrolled in this arm will undergo emergency cholecystectomy first without any common bile duct imaging |
| Sequential common bile duct imaging/cholecystectomy | Active comparator | Procedure: Sequential common bile duct imaging/cholecystectomyPatients enrolled in this arm will undergo common bile duct imaging and, if needed, ERCP first followed by emergency cholecystectomy |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients must have a clinical diagnosis of gallstone migration, defined as right upper quadrant or epigastric abdominal pain and abnormal liver function tests (increase of at least two common hepatic parameters [AST, ALT, alkaline phosphatase, gGT and/or bilirubin], with one of them being either AST or ALT with a value at least two times higher than the norm) with a reasonable exclusion of other common differential diagnoses
- Patients will be included regardless the presence of an associated cholecystitis, defined as right upper quadrant abdominal pain, radiological signs of cholecystitis (including radiological Murphy sign and/or thickened gallbladder wall and/or free abdominal fluid around the gallbladder) and signs of infection (including fever, increased CRP or white blood cell count)
- Age ≥ 16 years
Key exclusion criteria (6 listed)
- Presence of CBD stone on CT or US performed on admission (which will require ERCP exploration prior to surgery)
- Associated radiologically proven gallstone pancreatitis
- Associated cholangitis
- Medical conditions preventing surgery such as acute stroke, acute coronary syndrome, severe cardiac failure (NYHA class IV and/or respiratory failure with SpO2 < 85% with room air and/or LVEF < 35%), severe COPD with VEMS < 30 % of predicted value
- Medical conditions preventing informed consent
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 |
|---|---|---|
| Emergency cholecystectomy firstThe intervention is an emergency cholecystectomy without prior common bile duct imaging | Procedure or surgery | Cholecystectomy first |
| Sequential common bile duct imaging/cholecystectomyThis intervention is a common bile duct imaging modality and, if needed, ERCP first followed in the same hospital stay by a cholecystectomy | Procedure or surgery | Sequential common bile duct imaging/cholecystectomy |
Primary outcome
Hospital stay [days]
Time frame: 0 - 30 days
We will evaluate if our "new treatment" arm will have a decreased hospital stay. We do not expect patients to stay more than 30 days.
2 secondary outcomes
Morbidity
Time frame: 6 months
Mortality
Time frame: 6 months
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 13 Aug 2013.
- Derived from this study: PubMed 25005650Iranmanesh P, Frossard JL, Mugnier-Konrad B, Morel P, Majno P, Nguyen-Tang T, Berney T, Mentha G, Toso C. Initial cholecystectomy vs sequential common duct endoscopic assessment and subsequent cholecystectomy for suspected gallstone migration: a randomized clinical trial. JAMA. 2014 Jul;312(2):137-44. doi: 10.1001/jama.2014.7587.
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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.
Pouya Iranmanesh, MD principal investigator
University Hospital, Geneva
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Emergency cholecystectomy first and Sequential common bile duct imaging/cholecystectomy in people with Cholelithiasis and Cholecystitis, run by University Hospital, Geneva at 1 site in Switzerland.
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 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2013. 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 Switzerland. 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?
Hospital stay [days] (time frame: 0 - 30 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 NCT01492790, 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 13 Aug 2013.