Early Versus Delayed Surgery for Gallstone Pancreatitis

Gallstone Pancreatitis Clinical Trial

Official title:

Early Versus Delayed Surgery for Gallstone Pancreatitis: A Prospective Randomized

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00863642
• Other study ID #: 12935-01
• Status: Completed
• Phase: N/A
• First received: March 16, 2009
• Last updated: September 25, 2011
• Start date: November 2007
• Est. completion date: November 2009

Study information

• Verified date: September 2011
• Source: Los Angeles Biomedical Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cholecystolithiasis
• Cholelithiasis
• Gallstone Pancreatitis
• Gallstones
• Pancreatitis

Intervention

Procedure:
• Laparoscopic cholecystectomy within 48 hours of admission
Patients are taken to the operating room for laparoscopic cholecystectomy within 48 hours of admission
• Laparoscopic cholecystectomy after resolution of abdominal pain and laboratory values
Patients are taken to the operating room for laparoscopic cholecystectomy after resolution of abdominal pain and laboratory values

Locations

Country	Name	City	State
United States	Harbor-UCLA Medical Center	Torrance	California

Sponsors (2)

Lead Sponsor	Collaborator
Los Angeles Biomedical Research Institute	University of California, Los Angeles

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. Epub 2007 Sep 17. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of hospital stay		Days in the hospital	No
Secondary	Rates of conversion to open surgery, complication rates and rates of need for endoscopic retrograde cholangiogram		Within 30 days	Yes