Robot-assisted versus open lateral pancreaticojejunostomy for symptomatic chronic pancreatitis
Robot-assisted Versus Open Lateral Pancreaticojejunostomy for the Treatment of Symptomatic Chronic Pancreatitis (PANACOTTA): a Multicenter Randomized Controlled Trial
This trial will test whether robot-assisted or open lateral pancreaticojejunostomy leads to better early recovery for adults with chronic pancreatitis and a dilated main pancreatic duct.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 28 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) Academic / other |
| Locations | 1 site (Amsterdam) |
| Trial ID | NCT07109180 on ClinicalTrials.gov |
What this trial studies
PANACOTTA is a multicenter randomized controlled trial in the Netherlands comparing robot-assisted and open lateral pancreaticojejunostomy in adults with symptomatic chronic pancreatitis and a dilated pancreatic duct. Eligible patients are randomized to receive either a robot-assisted or an open surgical approach and are followed for post-operative recovery metrics and complications. The primary emphasis is on quality of recovery after surgery, with collection of clinical outcomes, pain measures, and length of stay. Participating centers include Amsterdam UMC, Erasmus MC, Maastricht UMC, and St. Antonius Hospital.
Who should consider this trial
Good fit: Adults (≥18 years) with confirmed chronic pancreatitis by M-ANNHEIM criteria, symptomatic pain or recurrent flares, a dilated pancreatic duct ≥5 mm and a non-enlarged pancreatic head (<40 mm) who are eligible for both robot-assisted and open surgery are ideal candidates.
Not a fit: Patients with suspected or confirmed pancreatic cancer, prior pancreatic surgery, ASA class ≥4, pregnancy, or other pain conditions that cannot be distinguished from their pancreatitis are unlikely to benefit from enrollment.
Why it matters
Potential benefit: If successful, the robot-assisted approach could shorten recovery time and reduce pain and hospital stay compared with the open operation.
How similar studies have performed: Open lateral pancreaticojejunostomy is an established operation, while robotic pancreatic surgery has promising case series but few randomized comparisons specifically for lateral pancreaticojejunostomy.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * At least 18 years old * Indication for (extended or partial) lateral pancreaticojejunostomy as agreed during multidisciplinary team meeting based on symptomatic chronic pancreatitis (i.e. morphine dependent pain or recurrent acute flares of pancreatitis, at least 3 episodes per year) and a dilated pancreatic duct of ≥ 5 mm, with a non-enlarged pancreatic head \< 40 mm * Confirmed CP, according to the M-ANNHEIM diagnostic Criteria24 * Eligible for both an robot-assisted and open approach * Obtained written informed consent Exclusion Criteria: * Suspected or confirmed current pancreatic cancer * ASA classification ≥ 4 * Other painful conditions aside from CP, with pain difficult to discriminate from CP pain * Prior pancreatic surgery * Pregnancy
Where this trial is running
Amsterdam
- Amsterdam UMC — Amsterdam, Netherlands (Recruiting)
Study contacts
- Principal investigator: M.G. Besselink, Amsterdam UMC — prof. dr.
- Study coordinator: E. Kilinc
- Email: e.kilinc@amsterdamumc.nl
- Phone: +31652741059
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.