Early Versus Delayed Surgery for Gallstone Pancreatitis

NCT00863642 | Completed DMC

• 1 other identifier: 12935-01
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Gallstone Pancreatitis

Keywords

Early cholecystectomy; gallstone pancreatitis

Outcome Measures

Primary Outcomes (1)

• Length of hospital stay

  Days in the hospital

Secondary Outcomes (1)

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

  Within 30 days

Study Arms (2)

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.

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.

Procedure: Laparoscopic cholecystectomy after resolution of abdominal pain and laboratory values

Interventions

Laparoscopic cholecystectomy within 48 hours of admission PROCEDURE

Patients are taken to the operating room for laparoscopic cholecystectomy within 48 hours of admission

Early

Laparoscopic cholecystectomy after resolution of abdominal pain and laboratory values PROCEDURE

Patients are taken to the operating room for laparoscopic cholecystectomy after resolution of abdominal pain and laboratory values

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center: lead
• University of California, Los Angeles: collaborator

Study Sites (1)

Harbor-UCLA Medical Center

Torrance, California, 90509, United States

Location

Related Publications (2)

• 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.

  PMID: 18035259 BACKGROUND

• 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.

  PMID: 20101174 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Surgery

Study Record Dates

• First Submitted: March 16, 2009
• First Posted: March 18, 2009
• Study Start: November 1, 2007
• Primary Completion: November 1, 2009
• Study Completion: November 1, 2009
• Last Updated: September 27, 2011

Record last verified: 2011-09

Locations

US (1)