Gallstone PancreatitisNCT00863642
Early Versus Delayed Surgery for Gallstone Pancreatitis
A study testing Laparoscopic cholecystectomy within 48 hours of admission and Laparoscopic cholecystectomy after resolution of abdominal pain and laboratory values in people with Gallstone Pancreatitis, run by Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center at 1 site in United States.
Trial summary
While there exists consensus among surgeons that patients with gallstone pancreatitis should undergo cholecystectomy to prevent recurrence, the precise timing of laparoscopic cholecystectomy for mild to moderate disease remains controversial. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gallstone Pancreatitis
- What is being tested?
- Laparoscopic cholecystectomy within 48 hours of admission and Laparoscopic cholecystectomy after resolution of abdominal pain and laboratory values
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2007to Nov 2009
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All adults are included between the age of 18 and 100 with mild to moderate gallstone pancreatitis.
- A subject is classified as having gallstone pancreatitis if they had the following:
- upper abdominal pain, nausea, vomiting and epigastric tenderness;
- absence of ethanol abuse;
- elevated amylase level to at least twice the upper limit of normal and elevated lipase level to at lease three times the upper limit of normal; and
- imaging confirmation of gallstones.
Show all 11Show fewer
- The classification of mild to moderate pancreatitis is defined by the presence of the following:
- three or fewer Ranson's criteria on admission: age > 55 years, glucose > 200 mg/dL , LDH> 350 mg/dL, AST > 250 units/L, and WBC>16 K/mm3;
- clinical stability with admission to a non-monitored ward bed;
- absence of acute cholangitis: defined as a temperature >38.6°C, right upper quadrant pain and tenderness, and significant hyperbilirubinemia; and
- low suspicion for a retained common bile duct (CBD) stone (total bilirubin <4 mg/dl on admission).
Who cannot join
- Severe pancreatitis (as defined by the presence of more than three Ranson's criteria on admission);
- Suspected concomitant acute cholangitis;
- High suspicion for retained common bile duct stone (total bilirubin ≥ 4 mg/dl on admission or ultrasound demonstration of CBD stone);
- Patient refusal to participate;
- Severe preexisting medical comorbidities contraindicating cholecystectomy (as determined by the primary physicians);
- Pregnancy,
- Prior gastric bypass surgery (making ERC difficult )
- Admission to a monitored unit. The need for admission to a monitored bed is determined by the admitting surgeon and is guided primarily by a need for aggressive fluid administration as demonstrated by severe volume depletion (e.g., admission tachycardia >110 beats/minute, blood urea nitrogen > 15 mg/dl) or evidence of cholangitis.
Trial locations and contacts
1 site in 1 country.
United States1 site
Harbor-UCLA Medical Center
Torrance, California, 90509
About this study
Official title: Early Versus Delayed Surgery for Gallstone Pancreatitis: A Prospective Randomized
While there exists consensus among surgeons that patients with gallstone pancreatitis should undergo cholecystectomy to prevent recurrence, the precise timing of laparoscopic cholecystectomy for mild to moderate disease remains controversial. We hypothesize that laparoscopic cholecystectomy performed within 48 hours of admission, regardless of resolution of abdominal pain or abnormal laboratory values, will result in a shorter hospital stay.
Read the detailed description
Acute pancreatitis is a common diagnosis worldwide, with more than 220,000 cases reported annually in the United States alone. The leading etiology is gallstones.1 Gallstone pancreatitis is thought to occur due to transient obstruction of the common channel that drains both the biliary and pancreatic ducts, resulting in inflammation of the pancreas. The pancreatitis that ensues is usually mild and self-limited and the treatment is initially supportive with subsequent laparoscopic cholecystectomy (LC). However, a small subgroup of patients develop severe pancreatitis and/or concomitant cholangitis. When the latter is present, ERC and sphincterotomy with stone extraction as indicated are typically performed.
While there is a clear consensus that patients who present with gallstone pancreatitis should undergo cholecystectomy to prevent recurrence, precise timing of surgery remains controversial. In patients with severe pancreatitis (Ranson's > 3), there is consensus that surgery is delayed until the pancreatitis has resolved because early operation is associated with a higher complication rate. 2 However, despite more than 30 years of debate in the surgical literature, the optimal timing of surgery in mild to moderate pancreatitis (Ranson's ≤ 3) remains unclear. With recurrence rates for gallstone pancreatitis reported as high as 63%3 and with some of the repeat attacks occurring within two weeks of initial index presentation1, most investigators have recommended cholecystectomy during the initial hospitalization.4,5 Still, the actual timing of surgery during the initial index hospitalization is unsettled. In practice, surgeons often delay surgery until there is evidence of complete resolution of the inflammatory process, as evidenced by absence of abdominal pain and normalization of liver functional tests and pancreatic enzymes.6 Unfortunately, this strategy may result in prolongation of hospitalization without any proven benefit.
A previous prospective, non-randomized study from our institution suggested that early cholecystectomy could safely be performed within 48 hours of admission in patients with mild to moderate pancreatitis, regardless of resolution of abdominal pain and abnormal laboratory values. In this study, when compared to a retrospective control group in which surgery was delayed until there was resolution of clinical and laboratory parameters, hospital stay was significantly reduced from a median of 7 days to 4 days, without additional complications.7 In order to address the optimal timing of surgery in a more definite fashion, a prospective randomized study was performed in which patients with mild to moderate gallstone pancreatitis were allocated to either an early group (surgery within 48 hours of presentation) or a control group (surgery after resolution of abdominal pain and normalization of laboratory values) and assessed overall outcomes.
- Conditions
- Gallstone Pancreatitis
- Being tested
- Laparoscopic cholecystectomy within 48 hours of admission, Laparoscopic cholecystectomy after resolution of abdominal pain and laboratory values
- Keywords
- Early cholecystectomy, gallstone pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic cholecystectomy within 48 hours of admissionProcedure or surgery
Patients are taken to the operating room for laparoscopic cholecystectomy within 48 hours of admission
Laparoscopic cholecystectomy after resolution of abdominal pain and laboratory valuesProcedure or surgery
Patients are taken to the operating room for laparoscopic cholecystectomy after resolution of abdominal pain and laboratory values
| Study group | Role | What they receive |
|---|---|---|
| Early | Experimental | In patients who present with mild to moderate gallstone pancreatitis, those randomized to the early arm will undergo laparoscopic cholecystectomy within 48 hours of admission, regardless of laboratory values normalization and resolution of abdominal pain. Receives: Procedure: Laparoscopic cholecystectomy within 48 hours of admission |
| Control | Other | In patients in the control arm, laparoscopic cholecystectomy is delayed until laboratory values normalize and abdominal pain resolves. Receives: Procedure: Laparoscopic cholecystectomy after resolution of abdominal pain and laboratory values |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of hospital stay
Measured: Days in the hospital
Secondary outcomes (1)
Rates of conversion to open surgery, complication rates and rates of need for endoscopic retrograde cholangiogram
Measured: Within 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2009 (estimated)
- Study startNov 2007
- Primary completionNov 2009
- Study completionNov 2009
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 Gallstone PancreatitisStudies 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 (estimated)
Sponsor and investigators
- Lead sponsor
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Los Angeles
- Responsible party
- Principal investigator, christian de virgilio, Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00863642
- Sponsor's protocol ID
- 12935-01
- Status last verified
- Sep 2011
- First submitted
- 16 Mar 2009
- Last updated
- 27 Sep 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Rosing DK, de Virgilio C, Yaghoubian A, Putnam BA, El Masry M, Kaji A, Stabile BE. Early cholecystectomy for mild to moderate gallstone pancreatitis shortens hospital stay. J Am Coll Surg. 2007 Dec;205(6):762-6. doi: 10.1016/j.jamcollsurg.2007.06.291. Epub 2007 Sep 17.
PubMed 18035259Aboulian A, Chan T, Yaghoubian A, Kaji AH, Putnam B, Neville A, Stabile BE, de Virgilio C. Early cholecystectomy safely decreases hospital stay in patients with mild gallstone pancreatitis: a randomized prospective study. Ann Surg. 2010 Apr;251(4):615-9. doi: 10.1097/SLA.0b013e3181c38f1f.
PubMed 20101174
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Versus Delayed Surgery for Gallstone Pancreatitis: A Prospective Randomized
- ClinicalTrials.gov ID
- NCT00863642
- Acronym / sponsor ID
- 12935-01
- Conditions
- Gallstone Pancreatitis
- Keywords
- Early cholecystectomy, gallstone pancreatitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical CenterUniversity, hospital or other
- Collaborators
- University of California, Los Angeles
- Study start
- Nov 2007
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 18 Mar 2009 (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.
While there exists consensus among surgeons that patients with gallstone pancreatitis should undergo cholecystectomy to prevent recurrence, the precise timing of laparoscopic cholecystectomy for mild to moderate disease remains controversial. We hypothesize that laparoscopic cholecystectomy performed within 48 hours of admission, regardless of resolution of abdominal pain or abnormal laboratory values, will result in a shorter hospital stay.
Detailed description
Acute pancreatitis is a common diagnosis worldwide, with more than 220,000 cases reported annually in the United States alone. The leading etiology is gallstones.1 Gallstone pancreatitis is thought to occur due to transient obstruction of the common channel that drains both the biliary and pancreatic ducts, resulting in inflammation of the pancreas. The pancreatitis that ensues is usually mild and self-limited and the treatment is initially supportive with subsequent laparoscopic cholecystectomy (LC). However, a small subgroup of patients develop severe pancreatitis and/or concomitant cholangitis. When the latter is present, ERC and sphincterotomy with stone extraction as indicated are typically performed.
While there is a clear consensus that patients who present with gallstone pancreatitis should undergo cholecystectomy to prevent recurrence, precise timing of surgery remains controversial. In patients with severe pancreatitis (Ranson's > 3), there is consensus that surgery is delayed until the pancreatitis has resolved because early operation is associated with a higher complication rate. 2 However, despite more than 30 years of debate in the surgical literature, the optimal timing of surgery in mild to moderate pancreatitis (Ranson's ≤ 3) remains unclear. With recurrence rates for gallstone pancreatitis reported as high as 63%3 and with some of the repeat attacks occurring within two weeks of initial index presentation1, most investigators have recommended cholecystectomy during the initial hospitalization.4,5 Still, the actual timing of surgery during the initial index hospitalization is unsettled. In practice, surgeons often delay surgery until there is evidence of complete resolution of the inflammatory process, as evidenced by absence of abdominal pain and normalization of liver functional tests and pancreatic enzymes.6 Unfortunately, this strategy may result in prolongation of hospitalization without any proven benefit.
A previous prospective, non-randomized study from our institution suggested that early cholecystectomy could safely be performed within 48 hours of admission in patients with mild to moderate pancreatitis, regardless of resolution of abdominal pain and abnormal laboratory values. In this study, when compared to a retrospective control group in which surgery was delayed until there was resolution of clinical and laboratory parameters, hospital stay was significantly reduced from a median of 7 days to 4 days, without additional complications.7 In order to address the optimal timing of surgery in a more definite fashion, a prospective randomized study was performed in which patients with mild to moderate gallstone pancreatitis were allocated to either an early group (surgery within 48 hours of presentation) or a control group (surgery after resolution of abdominal pain and normalization of laboratory values) and assessed overall outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early | Experimental | Procedure: Laparoscopic cholecystectomy within 48 hours of admissionIn patients who present with mild to moderate gallstone pancreatitis, those randomized to the early arm will undergo laparoscopic cholecystectomy within 48 hours of admission, regardless of laboratory values normalization and resolution of abdominal pain. |
| Control | Other | Procedure: Laparoscopic cholecystectomy after resolution of abdominal pain and laboratory valuesIn patients in the control arm, laparoscopic cholecystectomy is delayed until laboratory values normalize and abdominal pain resolves. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- All adults are included between the age of 18 and 100 with mild to moderate gallstone pancreatitis.
- A subject is classified as having gallstone pancreatitis if they had the following:
- The classification of mild to moderate pancreatitis is defined by the presence of the following:
Key exclusion criteria (8 listed)
- Severe pancreatitis (as defined by the presence of more than three Ranson's criteria on admission);
- Suspected concomitant acute cholangitis;
- High suspicion for retained common bile duct stone (total bilirubin ≥ 4 mg/dl on admission or ultrasound demonstration of CBD stone);
- Patient refusal to participate;
- Severe preexisting medical comorbidities contraindicating cholecystectomy (as determined by the primary physicians);
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 |
|---|---|---|
| Laparoscopic cholecystectomy within 48 hours of admissionPatients are taken to the operating room for laparoscopic cholecystectomy within 48 hours of admission | Procedure or surgery | Early |
| Laparoscopic cholecystectomy after resolution of abdominal pain and laboratory valuesPatients are taken to the operating room for laparoscopic cholecystectomy after resolution of abdominal pain and laboratory values | Procedure or surgery | Control |
Primary outcome
Length of hospital stay
Time frame: Days in the hospital
1 secondary outcome
Rates of conversion to open surgery, complication rates and rates of need for endoscopic retrograde cholangiogram
Time frame: Within 30 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 27 Sep 2011.
- Background: PubMed 18035259Rosing DK, de Virgilio C, Yaghoubian A, Putnam BA, El Masry M, Kaji A, Stabile BE. Early cholecystectomy for mild to moderate gallstone pancreatitis shortens hospital stay. J Am Coll Surg. 2007 Dec;205(6):762-6. doi: 10.1016/j.jamcollsurg.2007.06.291. Epub 2007 Sep 17.
- Derived from this study: PubMed 20101174Aboulian A, Chan T, Yaghoubian A, Kaji AH, Putnam B, Neville A, Stabile BE, de Virgilio C. Early cholecystectomy safely decreases hospital stay in patients with mild gallstone pancreatitis: a randomized prospective study. Ann Surg. 2010 Apr;251(4):615-9. doi: 10.1097/SLA.0b013e3181c38f1f.
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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.
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 Laparoscopic cholecystectomy within 48 hours of admission and Laparoscopic cholecystectomy after resolution of abdominal pain and laboratory values in people with Gallstone Pancreatitis, run by Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center 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 11 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 27 Sep 2011. 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?
Length of hospital stay (time frame: Days in the hospital). 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 NCT00863642, 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 27 Sep 2011; AzTrials last refreshed its copy on 1 Nov 2026.