Acute CholecystitisPhase 3ACDCNCT00447304
Acute Cholecystitis - Early Laparoscopic Surgery Versus Antibiotic Therapy and Delayed Elective Cholecystectomy
A Phase 3 study testing moxifloxacin and cholecystectomy in people with Acute Cholecystitis, run by Heidelberg University at 1 site in Germany.
Trial summary
Acute cholecystitis is frequent in the elderly, or in patients with gall stones. Most cases of severe or recurrent cholecystitis need surgery as final therapy. Today, the performed procedure in most cases for cholecystectomy in the western world is laparoscopic cholecystectomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Cholecystitis
- What is being tested?
- moxifloxacin and cholecystectomy
- Type of treatment
- Surgery or procedure
- How many people
- 644 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2006to Dec 2010
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients of age > 18 years
- Patients with acute cholecystitis based on three of the following signs
- abdominal pain in the upper right quadrant
- Murphy's sign
- leucocytosis > 10 /ml
- rectal temperature > 38 °C or < 36.5 °C plus
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- cholecystolithiasis (stones / sludge) or sonographic signs of cholecystitis (thickening and triple layer formation of the gall bladder wall)
- Immediate antibiotic therapy (400 mg Moxifloxacin i.v. once a day)
- Laparoscopic cholecystectomy possible within 24 hours after presentation of the patient
- Informed consent
Who cannot join
- ASA IV and V (table 2)
- Septic shock
- Perforation or abscess of the gall bladder
- Impossibility of laparoscopic surgery (further surgery, surgeon, …)
- Additional need of antibiotics due to secondary disease
- Known intolerability of Moxifloxacin
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- Known or possible pregnancy, breast feeding
- Life-threatening diseases (life-expectancy < 48 hours)
- End-stage liver disease (Child-Pugh C)
- Psychiatric or severe neurologic disease
- Relevant bradycardia or other symptomatic arrhythmias
- Significant cardiac disease
- Known long QT-disorders
- Electrolyte disorders, especially hypocalcemia
- Known intolerability of chinolones
- Earlier participation in this trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acute Cholecystitis - Early Laparoscopic Surgery Versus Antibiotic Therapy and Delayed Elective Cholecystectomy = ACDC-study
Acute cholecystitis is frequent in the elderly, or in patients with gall stones. Most cases of severe or recurrent cholecystitis need surgery as final therapy. Today, the performed procedure in most cases for cholecystectomy in the western world is laparoscopic cholecystectomy. Only in some cases an open surgery has to be performed. Unclear is, what time point is best, concerning outcome and morbidity of the patient, immediate surgery or initial conservative therapy using antibiotics and symptomatic therapy with cholecystectomy later on. Today the performed procedure is mainly chosen by the fact, what doctor sees the patient first, surgeon or gastroenterologist. This study is performed to evaluate if one therapy is superior.
- Conditions
- Acute Cholecystitis
- Being tested
- moxifloxacin, cholecystectomy
- Keywords
- acute cholecystitis, cholecystectomy, antibiotic treatment, moxifloxacin, intraabdominal infection, morbidity and mortality of patients with acute cholecystitis, early surgery versus conservative therapy
- Medical subject headings
- Cholecystitis, Acute, Intraabdominal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
moxifloxacinDrug
cholecystectomyProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
morbidity at the test-of-cure visit
Secondary outcomes (9)
Morbidity over 75 days using the score system showed in table 1
Morbidity 3 days after cholecystectomy (early or elective)
Necessity rate of conversion from laparoscopic to open surgery
Change of antibiotic due to non-response or non-toleration of moxifloxacin
Mortality at day 75
Cost-efficiency (comparing both trial branches)
Hospital time
Safety and tolerability of Moxifloxacin
In-hospital time after cholecystectomy (days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2007 (estimated)
- Study startOct 2006
- Primary completionNov 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute CholecystitisStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 644 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer
- Investigators
- Markus W Buechler, Prof., Study director, University Hospital Heidelberg, Department of Surgery, Heidelberg, GermanyWolfgang Stremmel, Prof, Study director, University Hospital Heidelberg, Department of Gastroenterology, Heidelberg, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00447304
- Sponsor's protocol ID
- 2006-002056-14
- Other IDs
- AC-DC-01/Version 02/6.04.06
- Acronym
- ACDC
- Status last verified
- Mar 2007
- First submitted
- 13 Mar 2007
- Last updated
- 23 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Gutt CN, Encke J, Koninger J, Harnoss JC, Weigand K, Kipfmuller K, Schunter O, Gotze T, Golling MT, Menges M, Klar E, Feilhauer K, Zoller WG, Ridwelski K, Ackmann S, Baron A, Schon MR, Seitz HK, Daniel D, Stremmel W, Buchler MW. Acute cholecystitis: early versus delayed cholecystectomy, a multicenter randomized trial (ACDC study, NCT00447304). Ann Surg. 2013 Sep;258(3):385-93. doi: 10.1097/SLA.0b013e3182a1599b.
PubMed 24022431Weigand K, Koninger J, Encke J, Buchler MW, Stremmel W, Gutt CN. Acute cholecystitis - early laparoskopic surgery versus antibiotic therapy and delayed elective cholecystectomy: ACDC-study. Trials. 2007 Oct 4;8:29. doi: 10.1186/1745-6215-8-29.
PubMed 17916243
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Cholecystitis - Early Laparoscopic Surgery Versus Antibiotic Therapy and Delayed Elective Cholecystectomy = ACDC-study
- ClinicalTrials.gov ID
- NCT00447304
- Acronym / sponsor ID
- ACDC / 2006-002056-14
- Conditions
- Acute Cholecystitis
- Keywords
- acute cholecystitis, cholecystectomy, antibiotic treatment, moxifloxacin, intraabdominal infection, morbidity and mortality of patients with acute cholecystitis, early surgery versus conservative therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 644 participants (estimated)
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- Collaborators
- Bayer
- Study start
- Oct 2006
- Primary completion
- Nov 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 14 Mar 2007 (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.
Acute cholecystitis is frequent in the elderly, or in patients with gall stones. Most cases of severe or recurrent cholecystitis need surgery as final therapy. Today, the performed procedure in most cases for cholecystectomy in the western world is laparoscopic cholecystectomy. Only in some cases an open surgery has to be performed. Unclear is, what time point is best, concerning outcome and morbidity of the patient, immediate surgery or initial conservative therapy using antibiotics and symptomatic therapy with cholecystectomy later on. Today the performed procedure is mainly chosen by the fact, what doctor sees the patient first, surgeon or gastroenterologist. This study is performed to evaluate if one therapy is superior.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients of age > 18 years
- Patients with acute cholecystitis based on three of the following signs
- Immediate antibiotic therapy (400 mg Moxifloxacin i.v. once a day)
- Laparoscopic cholecystectomy possible within 24 hours after presentation of the patient
- Informed consent
Key exclusion criteria (16 listed)
- ASA IV and V (table 2)
- Septic shock
- Perforation or abscess of the gall bladder
- Impossibility of laparoscopic surgery (further surgery, surgeon, …)
- Additional need of antibiotics due to secondary disease
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 |
|---|---|---|
| moxifloxacin | Drug | – |
| cholecystectomy | Procedure or surgery | – |
Primary outcome
morbidity at the test-of-cure visit
9 secondary outcomes
Morbidity over 75 days using the score system showed in table 1
Morbidity 3 days after cholecystectomy (early or elective)
Necessity rate of conversion from laparoscopic to open surgery
Change of antibiotic due to non-response or non-toleration of moxifloxacin
Mortality at day 75
Cost-efficiency (comparing both trial branches)
Hospital time
Safety and tolerability of Moxifloxacin
In-hospital time after cholecystectomy (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 23 Jul 2012.
- Derived from this study: PubMed 24022431Gutt CN, Encke J, Koninger J, Harnoss JC, Weigand K, Kipfmuller K, Schunter O, Gotze T, Golling MT, Menges M, Klar E, Feilhauer K, Zoller WG, Ridwelski K, Ackmann S, Baron A, Schon MR, Seitz HK, Daniel D, Stremmel W, Buchler MW. Acute cholecystitis: early versus delayed cholecystectomy, a multicenter randomized trial (ACDC study, NCT00447304). Ann Surg. 2013 Sep;258(3):385-93. doi: 10.1097/SLA.0b013e3182a1599b.
- Derived from this study: PubMed 17916243Weigand K, Koninger J, Encke J, Buchler MW, Stremmel W, Gutt CN. Acute cholecystitis - early laparoskopic surgery versus antibiotic therapy and delayed elective cholecystectomy: ACDC-study. Trials. 2007 Oct 4;8:29. doi: 10.1186/1745-6215-8-29.
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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.
Markus W Buechler, Prof. study director
University Hospital Heidelberg, Department of Surgery, Heidelberg, Germany
Wolfgang Stremmel, Prof study director
University Hospital Heidelberg, Department of Gastroenterology, Heidelberg, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing moxifloxacin and cholecystectomy in people with Acute Cholecystitis, run by Heidelberg University at 1 site in Germany.
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 10 inclusion and 16 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 23 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
morbidity at the test-of-cure visit. 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 NCT00447304, which also lists 2 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 23 Jul 2012.