Robot-assisted Versus Open Lateral Pancreaticojejunostomy for the Treatment of Symptomatic Chronic Pancreatitis (PANACOTTA)

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Robot-assisted lateral pancreaticojejunostomy
  • Open lateral pancreaticojejunostomy

Treatment groups

28 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Lead sponsor

St. Antonius Hospital

Collaborator

Erasmus Medical Center

Collaborator

Maastricht University Medical Center

Collaborator

Universitätsklinikum Hamburg-Eppendorf

Collaborator

University Medical Center Groningen

Collaborator

Onze Lieve Vrouwe Gasthuis

Collaborator

Catharina Ziekenhuis Eindhoven

Collaborator

Radboud University Medical Center

Collaborator

Medisch Spectrum Twente

Collaborator

Leiden University Medical Center

Collaborator