Chronic PancreatitisPANACOTTANCT07109180
Robot-assisted Versus Open Lateral Pancreaticojejunostomy for the Treatment of Symptomatic Chronic Pancreatitis (PANACOTTA)
A study testing Robot-assisted lateral pancreaticojejunostomy and Open lateral pancreaticojejunostomy in people with Chronic Pancreatitis and Surgery, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pancreatitis, Surgery, Minimally Invasive Surgical Technique
- What is being tested?
- Robot-assisted lateral pancreaticojejunostomy and Open lateral pancreaticojejunostomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteNetherlands
- Study dates
- 16 Apr 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Robot-assisted Versus Open Lateral Pancreaticojejunostomy for the Treatment of Symptomatic Chronic Pancreatitis (PANACOTTA): a Multicenter Randomized Controlled Trial
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
- Being tested
- Robot-assisted lateral pancreaticojejunostomy, Open lateral pancreaticojejunostomy
- Medical subject headings
- Pancreatitis, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robot-assisted lateral pancreaticojejunostomyProcedure or surgery
Robot-assisted
Open lateral pancreaticojejunostomyProcedure or surgery
Open surgery
| Study group | Role | What they receive |
|---|---|---|
| Robot-assisted lateral pancreaticojejunostomy | Experimental | Not described Receives: Procedure: Robot-assisted lateral pancreaticojejunostomy |
| Open lateral pancreaticojejunostomy | Active comparator | Not described Receives: Procedure: Open lateral pancreaticojejunostomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2025
- Study start16 Apr 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PancreatitisStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1:1 randomization
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- St. Antonius Hospital, Erasmus Medical Center, Maastricht University Medical Center, Universitätsklinikum Hamburg-Eppendorf, University Medical Center Groningen, Onze Lieve Vrouwe Gasthuis, Catharina Ziekenhuis Eindhoven, Radboud University Medical Center, Medisch Spectrum Twente, Leiden University Medical Center
- Responsible party
- Principal investigator, M.G. Besselink, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- M.G. Besselink, Amsterdam UMC, Principal investigator, prof. dr.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07109180
- Sponsor's protocol ID
- NL87297.018.24
- Acronym
- PANACOTTA
- Status last verified
- Jul 2025
- First submitted
- 14 Jul 2025
- Last updated
- 7 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Robot-assisted Versus Open Lateral Pancreaticojejunostomy for the Treatment of Symptomatic Chronic Pancreatitis (PANACOTTA): a Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07109180
- Acronym / sponsor ID
- PANACOTTA / NL87297.018.24
- Conditions
- Chronic Pancreatitis, Surgery, Minimally Invasive Surgical Technique, Robot Surgica, Robot Surgery, Minimally Invasive Surgery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Collaborators
- St. Antonius Hospital, Erasmus Medical Center, Maastricht University Medical Center, Universitätsklinikum Hamburg-Eppendorf, University Medical Center Groningen, Onze Lieve Vrouwe Gasthuis, Catharina Ziekenhuis Eindhoven, Radboud University Medical Center, Medisch Spectrum Twente, Leiden University Medical Center
- Study start
- 16 Apr 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 7 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 1:1 randomization
| Arm | Type | Receives |
|---|---|---|
| Robot-assisted lateral pancreaticojejunostomy | Experimental | Procedure: Robot-assisted lateral pancreaticojejunostomy |
| Open lateral pancreaticojejunostomy | Active comparator | Procedure: Open lateral pancreaticojejunostomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Robot-assisted lateral pancreaticojejunostomyRobot-assisted | Procedure or surgery | Robot-assisted lateral pancreaticojejunostomy |
| Open lateral pancreaticojejunostomyOpen surgery | Procedure or surgery | Open lateral pancreaticojejunostomy |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
M.G. Besselink, Amsterdam UMC principal investigator
prof. dr.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robot-assisted lateral pancreaticojejunostomy and Open lateral pancreaticojejunostomy in people with Chronic Pancreatitis and Surgery, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact E. Kilinc (+31652741059, e.kilinc@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2025.