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

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)28 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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).

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Central Contacts