Chronic Pancreatitis, Minimally Invasive Surgery, Minimally Invasive Surgical Technique, Pancreaticojunostomy, Robot Surgery, Robot Surgica, Surgery
Conditions
Brief summary
PANACOTTA is a multicenter randomized controlled trial including patients with symptomatic chronic pancreatitis and a dilated main pancreatic duct to either robot-assisted or open lateral pancreaticojejunostomy. The PANACOTTA trial will assess the post-operative quality of recovery following robot-assisted versus open lateral pancreaticojejunostomy.
Interventions
Robot-assisted
PROCEDUREOpen lateral pancreaticojejunostomy
Open surgery
Sponsors
St. Antonius Hospital
Erasmus Medical Center
Maastricht University Medical Center
Universitätsklinikum Hamburg-Eppendorf
University Medical Center Groningen
Onze Lieve Vrouwe Gasthuis
Catharina Ziekenhuis Eindhoven
Radboud University Medical Center
Medisch Spectrum Twente
Leiden University Medical Center
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Patient-blinded up to post-operative day 5.
Intervention model description
1:1 randomization
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Recovery (QoR-15) | Daily assessments on Post-operative Day 1 through Day 5 and up to time of functional recovery, defined individually per patient (maximum of 90 days from surgery). | Primary objective: To assess post-operative mean Quality of Recovery (QoR-15) on post-operative days one through five and cumulative loss of QoR-15 until time of functional recovery of robot-assisted (RA) as compared to open lateral pancreaticojejunostomy (LPJ) in patients with symptomatic chronic pancreatitis and a dilated main pancreatic duct with a normal size pancreatic head. |
Countries
Netherlands
Contacts
Primary ContactE. Kilinc
Outcome results
None listed