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NCT Number: NCT07109180

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

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.

Recruiting

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Key information

Conditions

Chronic Pancreatitis Chronic Disease Digestive System Diseases Disease Attributes Minimally Invasive Surgery Minimally Invasive Surgical Technique Pancreatic Diseases Pancreaticojunostomy Pancreatitis Pancreatitis, Chronic Pathologic Processes Pathological Conditions, Signs and Symptoms Robot Surgery Robot Surgica Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Amsterdam UMC

Amsterdam, Netherlands

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Robot-assisted lateral pancreaticojejunostomy

Procedure

Robot-assisted

Open lateral pancreaticojejunostomy

Procedure

Open surgery

Primary outcomes

  1. 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).

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

E. Kilinc

CONTACT

[email protected]

+31652741059

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

  • Catharina Ziekenhuis Eindhoven
  • Erasmus Medical Center
  • Leiden University Medical Center
  • Maastricht University Medical Center
  • Medisch Spectrum Twente
  • Onze Lieve Vrouwe Gasthuis
  • Radboud University Medical Center
  • St. Antonius Hospital
  • University Medical Center Groningen
  • Universitätsklinikum Hamburg-Eppendorf

Registry information

Official study title

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

Acronym: PANACOTTA

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 7, 2025
Registry last updated
Aug 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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