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Early Versus Delayed Surgery for Gallstone Pancreatitis

Primary Purpose

Gallstone Pancreatitis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Laparoscopic cholecystectomy within 48 hours of admission
Laparoscopic cholecystectomy after resolution of abdominal pain and laboratory values
Sponsored by
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gallstone Pancreatitis focused on measuring Early cholecystectomy, gallstone pancreatitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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:

    1. upper abdominal pain, nausea, vomiting and epigastric tenderness;
    2. absence of ethanol abuse;
    3. 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
    4. imaging confirmation of gallstones.
  • The classification of mild to moderate pancreatitis is defined by the presence of the following:

    1. 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;
    2. clinical stability with admission to a non-monitored ward bed;
    3. absence of acute cholangitis: defined as a temperature >38.6°C, right upper quadrant pain and tenderness, and significant hyperbilirubinemia; and
    4. low suspicion for a retained common bile duct (CBD) stone (total bilirubin <4 mg/dl on admission).

Exclusion Criteria:

  • 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.

Sites / Locations

  • Harbor-UCLA Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Early

Control

Arm Description

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.

In patients in the control arm, laparoscopic cholecystectomy is delayed until laboratory values normalize and abdominal pain resolves.

Outcomes

Primary Outcome Measures

Length of hospital stay

Secondary Outcome Measures

Rates of conversion to open surgery, complication rates and rates of need for endoscopic retrograde cholangiogram

Full Information

First Posted
March 16, 2009
Last Updated
September 25, 2011
Sponsor
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Collaborators
University of California, Los Angeles
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1. Study Identification

Unique Protocol Identification Number
NCT00863642
Brief Title
Early Versus Delayed Surgery for Gallstone Pancreatitis
Official Title
Early Versus Delayed Surgery for Gallstone Pancreatitis: A Prospective Randomized
Study Type
Interventional

2. Study Status

Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
November 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Collaborators
University of California, Los Angeles

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gallstone Pancreatitis
Keywords
Early cholecystectomy, gallstone pancreatitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Early
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Other
Arm Description
In patients in the control arm, laparoscopic cholecystectomy is delayed until laboratory values normalize and abdominal pain resolves.
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic cholecystectomy within 48 hours of admission
Intervention Description
Patients are taken to the operating room for laparoscopic cholecystectomy within 48 hours of admission
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic cholecystectomy after resolution of abdominal pain and laboratory values
Intervention Description
Patients are taken to the operating room for laparoscopic cholecystectomy after resolution of abdominal pain and laboratory values
Primary Outcome Measure Information:
Title
Length of hospital stay
Time Frame
Days in the hospital
Secondary Outcome Measure Information:
Title
Rates of conversion to open surgery, complication rates and rates of need for endoscopic retrograde cholangiogram
Time Frame
Within 30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. 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). Exclusion Criteria: 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.
Facility Information:
Facility Name
Harbor-UCLA Medical Center
City
Torrance
State/Province
California
ZIP/Postal Code
90509
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18035259
Citation
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.
Results Reference
background
PubMed Identifier
20101174
Citation
Aboulian 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.
Results Reference
derived

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Early Versus Delayed Surgery for Gallstone Pancreatitis

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