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

A

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

Status

Enrolling

Conditions

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

Treatments

Procedure: Open lateral pancreaticojejunostomy
Procedure: Robot-assisted lateral pancreaticojejunostomy

Study type

Interventional

Funder types

Other

Identifiers

NCT07109180
NL87297.018.24

Details and patient eligibility

About

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.

Enrollment

28 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

28 participants in 2 patient groups

Robot-assisted lateral pancreaticojejunostomy
Experimental group
Treatment:
Procedure: Robot-assisted lateral pancreaticojejunostomy
Open lateral pancreaticojejunostomy
Active Comparator group
Treatment:
Procedure: Open lateral pancreaticojejunostomy

Trial contacts and locations

1

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Central trial contact

E. Kilinc

Data sourced from clinicaltrials.gov

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