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

NCT07109180 | Recruiting DMC

• 1 other identifier: NL87297.018.24
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pancreatitis; Surgery; Minimally Invasive Surgical Technique; Robot Surgica; Robot Surgery; Minimally Invasive Surgery; Pancreaticojunostomy

Outcome Measures

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.

  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).

Study Arms (2)

Robot-assisted lateral pancreaticojejunostomy

EXPERIMENTAL

Procedure: Robot-assisted lateral pancreaticojejunostomy

Open lateral pancreaticojejunostomy

ACTIVE COMPARATOR

Procedure: Open lateral pancreaticojejunostomy

Interventions

Robot-assisted lateral pancreaticojejunostomy PROCEDURE

Robot-assisted

Robot-assisted lateral pancreaticojejunostomy

Open lateral pancreaticojejunostomy PROCEDURE

Open surgery

Open lateral pancreaticojejunostomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead
• 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

Study Sites (1)

Amsterdam UMC

Amsterdam, Netherlands

RECRUITING

MeSH Terms

Conditions

Pancreatitis, Chronic

Condition Hierarchy (Ancestors)

Pancreatitis; Pancreatic Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• M.G. Besselink, Amsterdam UMC

  prof. dr.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

E. Kilinc

CONTACT

+31652741059; e.kilinc@amsterdamumc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patient-blinded up to post-operative day 5.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.G. Besselink

Model Details: 1:1 randomization

Study Record Dates

• First Submitted: July 14, 2025
• First Posted: August 7, 2025
• Study Start: April 16, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: August 7, 2025

Record last verified: 2025-07

Locations

NL (1)