Timing of CHolecystectomy in Severe PAncreatitis

Launched by HOSPITAL UNIVERSITARIO MAYOR MÉDERI · Oct 27, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the best timing for surgery to remove the gallbladder (a procedure called cholecystectomy) in patients who have a condition called pancreatitis, particularly those with moderately severe to severe cases. The researchers want to find out if doing the surgery early, while the patient is still hospitalized for pancreatitis, leads to better outcomes compared to waiting about four weeks after the pancreatitis has improved. They will look at serious complications from the surgery and other important factors, like recovery time and whether the patient needs intensive care afterward.

To participate in this trial, individuals must be at least 18 years old and diagnosed with moderately severe or severe pancreatitis, as defined by certain medical guidelines. They should have signs of gallbladder-related pancreatitis and need to be able to eat normally again before the surgery. However, people who are pregnant, have previously had their gallbladder removed, or have other serious health issues are not eligible. If someone joins the study, they will be randomly assigned to have their surgery either during their hospital stay or a few weeks later, and they will be monitored closely for their recovery.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age ≥18 years, diagnosis of pancreatitis according to Atlanta guidelines, moderately severe or severe pancreatitis (APACHE score ≥8 on admittance)
• • Biliary pancreatitis diagnosed on imaging (be it ultrasound, magnetic resonance imaging and/or tomography)
• • Recovery of pancreatitis by tolerance of oral intake (defined as 24 hours of food consumption of any consistency without emetic episodes and pain defined as 4/10 on the visual analogue score of pain) and written informed consent.
• Exclusion Criteria:
• • Pregnancy
• • History of cholecystectomy
• • Planned open cholecystectomy
• • Pancreatitis-associated complication before laparoscopic cholecystectomy (compartment syndrome, bleeding and/or need for peripancreatic collection drainage)
• • Chronic pancreatitis,
• • More than one episode of pancreatitis
• • Active malignant disease
• • Septic shock
• • Choledocholithiasis not resolved by ERCP, post-ERCP perforation and post-ERCP concomitant pancreatitis.