BACKGROUND AND PURPOSE:

• Laparoscopic cholecystectomy is recommended for uncomplicated gallstones, however
  • 10-41% of patients following cholecystectomy continue to experience abdominal pain
• van Dijk et al. (The Lancet, 2019) compared the effectiveness of a restrictive standardized strategy, limiting cholecystectomy to those with biliary symptoms vs usual care

METHODS:

• Multicenter, randomized, parallel-arm, non-inferiority trial (RCT)
• Participants
  • 18-95 years
  • Abdominal pain and ultrasound-proven gallstones or sludge
• Randomized to either
  • Usual care: Cholecystectomy left to physician discretion
  • A restrictive strategy selection strategy
• Restrictive strategy: For those who were symptomatic via triage instrument (Rome III criteria)
  • Severe pain attacks | Pain lasting ≥15-30 min | Epigastric or right upper quadrant pain | Pain radiating to the back | Positive pain response to simple analgesics
• Randomization stratified by center, sex, and body-mass index
• Blinding continued through to completion of triage instrument
• ‘Pain-free’ definition: Izbicki Pain Score of ≤10 | Visual analogue scale [VAS] pain score ≤4
• Primary outcome
  • The proportion of patients who were pain-free at 12 months’ follow-up, analyzed by intention to treat and per protocol
  • 5% non-inferiority margin was chosen based on the estimated clinically relevant difference
  • Based on estimate that the maximum proportion of pain-free patients following surgery would be 80%
  • Safety analyses were done in the intention-to treat population

RESULTS:

• 530 assigned to restrictive strategy | 537 assigned to usual care
  • 72% women in usual care | 75% women in restrictive care
• Primary outcome: Pain free at 12-month follow-up
  • Restrictive strategy: 56% (95% CI, 52.0–60.4)
  • Usual care: 60% (95% CI, 55.6–63.8)
  • Non-inferiority was not shown: Difference 3.6% (one-sided 95% lower CI −8.6%)
• Following cholecystectomy, patients reporting preoperative biliary colic were significantly more often pain-free at 12-month follow-up (p=0.005)
  • Pre-op colic: 61%
  • No pre-op colic: 52%
• Secondary outcome: Number of cholecystectomies
  • Restrictive strategy resulted in significantly fewer cholecystectomies than usual care (p=0.01)
    • Restrictive strategy: 68% | Usual care: 75%
• There were no between-group differences in gallstone or surgical complications

CONCLUSION:

• Both usual care and the restrictive strategy groups resulted in suboptimal pain reduction for those patients with gallstones and abdominal pain
  • 37% of patients still had pain following surgery
• However, the restrictive strategy was associated with fewer cholecystectomies
• The authors conclude that patient expectations should be managed prior to surgery and also state

Symptomatic gallstones might be an epiphenomenon of another condition, for which cholecystectomy is not the solution. Further investigation is needed to determine how to best select patients who truly have gallbladder stones, which patients might benefit from cholecystectomy, and whether gallstones and functional gastrointestinal problems coincide.

Learn More – Primary Sources:

Restrictive strategy versus usual care for cholecystectomy in patients with gallstones and abdominal pain (SECURE): a multicentre, randomised, parallel-arm, non-inferiority trial

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