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Recruiting NCT07109180

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

No phase Interventional Chronic Pancreatitis Surgery Minimally Invasive Surgical Technique Robot Surgica

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Robot-assisted lateral pancreaticojejunostomy, Open lateral pancreaticojejunostomy.
Who it may be relevant to
Registry conditions: Chronic Pancreatitis, Surgery, Minimally Invasive Surgical Technique, Robot Surgica. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Netherlands
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Robot-assisted Versus Open Lateral Pancreaticojejunostomy for the Treatment of Symptomatic Chronic Pancreatitis (PANACOTTA): a Multicenter Randomized Controlled Trial

Overview

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

  • Procedure Robot-assisted lateral pancreaticojejunostomy
    Robot-assisted
  • Procedure Open lateral pancreaticojejunostomy
    Open surgery

Primary outcome measures

  • Quality of Recovery (QoR-15) [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).]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Netherlands · 1 center
  • Amsterdam UMC — Amsterdam

Identifiers

NCT: NCT07109180 · NL87297.018.24

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗