PONCHO

Incomplete

da Costa. "Same-admission versus interval cholecystectomy for mild gallstone pancreatitis (PONCHO): a multicentre randomised controlled trial". The Lancet. 2015. 386(10000):1261-1268.
PubMed • Full text

Clinical Question

Among patients with mild biliary pancreatitis, does same-admission cholecystectomy reduce the risk of recurrent pancreatitis and its complications including mortality compared to 30 day interval cholecystectomy?

Bottom Line

In patients with mild biliary panceratitis, same admission cholecystectomy safely reduces the risk of recurrent pancreatitis and its sequelae.

Major Points

Gallstones account for up to 40% of cases of acute pancreatitis . Cholecystectomy greatly reduces the the risk of recurrent gallstone pancreatitis. The PONCHO trial demonstrated that performing the cholecystectomy during the same hospitalization greatly reduced the risk of 30 day readmission, predominantly from recurrent pancreatitis (9% to 2%). It further demonstrated no adverse effect of early timing (similar rates of bile duct leak, difficulty of operation, operating time, and length of stay). This trial added to previous studies that demonstrate that safety and efficacy of same admission cholecystectomy , and data by the same group indicates it is cost effective

Caution should be taken in generalizing these results to patients who either have local complications of pancreatitis (which can increase the difficulty of cholecystectomy) or have significant comorbidities that may require medical optimization. Same admission cholecystectomy may be harmful in moderate/severe acute biliary pancreatitis, peripancreatic fluid collections, or pseudocysts.

Guidelines

• World Society of Emergency Surgery 2019 Guidelines recommended laparoscopic cholecystectomy for mild acute gallstones pancreatitis (1A), even when ERCP and sphincterotomy are performed (1B). They recommended patients with peripancreatic fluid collections should undergo interval cholecystectomy (2C).

Design

• Setting: 23 hospitals in the Netherlands
• Enrollment: N=266, 136 interval cholecystectomy, 128 same admission cholecystectomy
  • 447 excluded
  • Dec 2010 - August 2013
• Follow-up: 6 month in interval group
• Analysis: intention-to-treat
• Primary outcome: Combined endpoint of acute readmission for gallstone-related complication or mortality

Population

Inclusion Criteria

• Adults
• 1st episode of pancreatitis
• Ultrasound evidence of gallstones/sludge/CBD dilation
• Pain controlled without opiates
• Tolerating a regular diet
• ASA class I to III

Exclusion Criteria

• Organ failure
• local pancreatic complication (fluid collection)
• CRP > 100

Baseline Characteristics

• Median data shown for same-admission cholecystectomy group (N= 128)
• Age (years) 53 (38-66)
• Female sex 76 (59%)
• BMI 27 (24-32)
• History of upper abdominal surgery 6%
• History of gallstone colic 30%
• History of cholecystitis 2%
• History of diabetes 9%
• ASA class
  • I 34%
  • 2 56%
  • 3 10%
• ERCP sphincterotomy prior to randomization 27%
• CRP mg/L prior to randomization
• days of admission before randomization 5(3-8)
• Days between randomization and cholecystectomy 1
  • Note this value is 27 (26-29) in the interval group

Interventions

• Interval Cholecystectomy
  • Interval cholecystectomy scheduled between 25-30 days from discharge
  • No intraoperative cholangiograms were performed

Outcomes

Comparisons are interval cholecystectomy vs. Same-admission cholecystectomy.’’

Primary Outcomes

Mortality or readmission for gallstone related complications

23 (17%) vs. 6 (5%) (RR 0.28, 95% CI 0.12-0.66, P=0.002)

Secondary Outcomes

Recurrent pancreatitis

9% vs. 2% (RR 0.27, 95% CI .08-0.92, P =.03)

Cholecystitis

2% vs. 0%

Choledocholithiasis requiring ERCP

2% vs. 1% (RR 0.53 95% CI .05-5.79, P =1.0)

Gallstone colic

5% vs. 2% (RR 0.3, 95% CI .06-1.43, P = .17)

Reported colics during waiting period

51% vs. 3% (RR .06, 95% CI .02-0.19, P = .03)

Median Difficulty of cholecystectomy on visual analogue scale

6 (range 4-7) vs. 6 (range 4-7) P=0.7:

• Operating time, length of stay, and need for ICU admission did not differ between the two groups

Subgroup Analysis

• Endoscopic sphincterotomy did not show an interaction with primary outcome.

Among patients who had undergone prior sphincterotomy

Mortality or readmission for gallstone related complications:

17%(7/42) vs. 3%(1/35) (P=.07)

• age < 75 and ≥75 years did not show an interaction effect with the primary outcome

Adverse Events

• Safety endpoints including cystic duct leakage, need for reoperation and blood transfusion were the same between both groups (1% in all cases)
• In the interval cholecystectomy group the need for additional intervention was 2% (radiologic intervention)
• In the same admission cholecystectomy group, 1 person needed additional surgical intervention, and 1 person needed additional endoscopic intervention
• 1 person in the interval cholecystectomy group suffered a pulmonary embolism
• There was 1 mortality in the same admission cholecystectomy group (ischemic stroke after hospitalization

==Criticisms== *

• Patients were generally healthy and mild cases (ASA III or lower, tolerating a diet with opioid medications), unclear extrapolation to sicker patients

Funding

• Dutch Digestive Disease Foundation (no role in analysis)