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

ConditionsChronic PancreatitisSurgeryMinimally Invasive Surgical TechniqueRobot SurgicaRobot SurgeryMinimally Invasive SurgeryPancreaticojunostomy
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Robot-assisted lateral pancreaticojejunostomy

    Procedure/Surgery

    Robot-assisted

  • Open lateral pancreaticojejunostomy

    Procedure/Surgery

    Open surgery

Treatment groups

28 Participants
are divided into 2 treatment groups
Group A: Robot-assisted lateral pancreaticojejunostomyExperimental treatment 1 intervention
Group B: Open lateral pancreaticojejunostomyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Quality of Recovery (QoR-15)

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.

Time frame
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).

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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

Source ClinicalTrials.gov
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