Chronic PancreatitisPhase 1NCT07810309
Metabolic Impact of Pancreatic Duct Decompression
A Phase 1 study testing Endoscopic pancreatic duct decompression in people with Chronic Pancreatitis, run by Mayo Clinic at 1 site in United States.
Trial summary
This study is a pilot study evaluating the impact of clearing out the pancreatic duct in patients with chronic pancreatitis who have a blockage in their pancreatic duct. While we typically perform procedures with an endoscope (a long flexible tube with a camera that goes through the mouth to reach the small intestine)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pancreatitis
- What is being tested?
- Endoscopic pancreatic duct decompression
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Oct 2026to Mar 2030
- Phase
- Phase 1
- 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
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged ≥ 18
- Chronic pancreatitis as defined by Cambridge grade 3 or 4 (3: > 3 abnormal side branches; 4: abnormal main duct and branches) pancreatic ductal changes and/or parenchymal and/or intraductal calcifications (chronic calcific pancreatitis) by CT Scan or MRI/MRCP24
- Minimally symptomatic:
- Asymptomatic patients who were incidentally diagnosed with chronic pancreatitis based on imaging
- Mild to moderate pain (visual analog scale ≤ 5) who do not require daily opioid pain medications
- ≤ 1 episode of uncomplicated acute pancreatitis in 12 months prior to enrollment
Who cannot join
- History of diabetes (defined as either a HbA1c ≥ 6.5 % or a fasting glucose ≥ 126 mg/dL)
- Pancreatic duct obstruction limited to the tail of pancreas
- Surgically altered forgot anatomy prohibitive of ERCP with standard techniques (e.g Billroth II, Roux-en-y gastric bypass, pancreaticoduodenectomy)
- Prior pancreatic surgery
- Pancreatic head mass or suspicion for pancreatic malignancy
- Concurrent extra-pancreatic malignancy other than non-melanoma skin cancer
Show all 12Show fewer
- Prior endoscopic therapy for pancreatic duct obstruction
- Acute pancreatitis < 90 days prior to enrollment
- Active alcohol use within 2 months of enrollment
- Gastrointestinal stricture/obstruction precluding passage of the duodenoscope to the papilla
- Standard contraindications to ERCP
- Unable to receive general anesthesia
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
LUis Ospina Velasquez, 507-538-1827, OspinaVelasquez.Luis@mayo.edu
Samuel Han, MD
About this study
Official title: Metabolic Impact of Endoscopic Pancreatic Duct Decompression: A Pilot Study
This study is a pilot study evaluating the impact of clearing out the pancreatic duct in patients with chronic pancreatitis who have a blockage in their pancreatic duct. While we typically perform procedures with an endoscope (a long flexible tube with a camera that goes through the mouth to reach the small intestine) to relieve a pancreatic duct blockage in patients with chronic pancreatitis who have pain and have a blockage, we do not know how relieving this blockage improves pancreatic function. Therefore, we are performing a preliminary study where participants will be randomized to either receiving an endoscopy or not undergoing an endoscopy. This will provide some background data to help inform us whether we should perform a larger study in the future to answer this question.
Read the detailed description
This single-center randomized controlled trial will compare endoscopic pancreatic duct decompression with medical management alone for the treatment of pancreatic duct obstruction in patients with minimally symptomatic chronic pancreatitis. Utilizing mixed-meal tolerance testing, endocrine function will be assessed at baseline and 6-months post-randomization. We hypothesize that rigorous metabolic testing using mixed-meal tolerance testing at baseline and 6-months post-randomization will be feasible.
The study intervention entails endoscopic pancreatic duct decompression which entails endoscopic retrograde cholangiopancreatography (ERCP) with or without extracorporeal shock wave lithotripsy (ESWL). Endoscopic treatment via ERCP ± ESWL will continue until pancreatic duct decompression is achieved. The control arm will receive medical management alone, defined as standard of care treatment per the discretion of the treating pancreatologist.
- Conditions
- Chronic Pancreatitis
- Being tested
- Endoscopic pancreatic duct decompression
- Keywords
- chronic pancreatitis, ERCP, pancreatic endocrine function, pancreatic exocrine function, diabetes, pancreatoscopy
- Medical subject headings
- Pancreatitis, Chronic, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic pancreatic duct decompressionProcedure or surgery
The study intervention is endoscopic pancreatic duct decompression, which will consist of endoscopic retrograde cholangiopancreatography (ERCP) with or without extracorporeal shockwave lithotripsy (ESWL). Treatment via ERCP +/- ESWL can be continued for multiple treatment sessions until the pancreatic duct has been decompressed, defined as complete resolution of the PD stricture (defined as > 90% resolution of the stenosis on pancreatography) and/or complete stone clearance (> 90% removal of PD stones) of any PD stones. Pancreatoscopy-guided lithotripsy can be performed during ERCP as well to help aid in stricture or stone therapy.
| Study group | Role | What they receive |
|---|---|---|
| Endoscopic pancreatic duct decompression (Intervention Arm) | Experimental | Participants in the intervention arm will receive endoscopic pancreatic duct decompression. Receives: Procedure: Endoscopic pancreatic duct decompression |
| No endoscopic intervention (Control Arm) | No intervention | The control arm will receive medical management alone, defined as standard of care treatment per the discretion of the treating pancreatologist. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of performing randomized-controlled trial in patients with minimally symptomatic chronic pancreatitis to assess metabolic function as defined via enrollment ratio, retention rate, and assessment completion rate.
Feasibility will be defined as follows:
For the study enrollment ratio, the total number of participants referred will form the denominator for the enrollment ratio, while the number of enrolled will form the numerator for the enrollment ratio. A 50% enrollment ratio will be indicative of feasibility.
Retention will be determined by the proportion of enrolled participants who remain in the study until completion of endotherapy and the end of assessment period. A 75% retention rate will be indicative of feasibility.
Assessment completion will be defined as completion of all baseline assessments and 6-months post-randomization assessments, including all metabolic tests. Participants who complete all assessments represent the numerators in the assessment completion ratio with the number of participants enrolled serving as the denominator in the assessment completion ratio. A 70% completion rate will indicate feasibility.
Measured: From enrollment to 6 months post-randomization
Secondary outcomes (2)
Impact of pancreatic duct decompression on pancreatic endocrine function as measured via insulin secretion.
The secondary endpoint will be the change in insulin secretion from baseline to 6-months post-randomization for each treatment arm.
Insulin secretion will be measured using mixed meal tolerance testing, which will be performed at baseline and 6-months post-randomization, during which serum C-peptide, insulin and glucose levels will be measured.
Insulin secretion will be calculated using the Area Under the Curve (AUC) of C-peptide. This will be calculated using the trapezoidal method. An AUC of the fasting serum glucose levels will be calculated in similar fashion. Insulin secretion will then be estimated by dividing the AUC for C-peptide by the AUC for glucose.
Measured: From enrollment to 6 months post-randomization
Impact of pancreatic duct decompression on pancreatic exocrine function as measured by fecal elastase.
Another secondary objective is to evaluate the impact of pancreatic duct decompression on pancreatic exocrine function, as measured using the fecal elastase test. The change in fecal elastase levels from baseline to 6-months post-randomization will be compared between treatment groups to assess the change in pancreatic exocrine function.
Measured: From enrollment to 6-months post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2026
- Study start30 Oct 2026
- Primary completionSep 2029 (estimated)
- Study completionMar 2030 (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 Mayo ClinicThe 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized-controlled trial
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Indiana University
- Responsible party
- Principal investigator, Samuel Han, Mayo Clinic
- Investigators
- Samuel Han, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07810309
- Sponsor's protocol ID
- 26-005624
- Status last verified
- Sep 2026
- First submitted
- 1 Sep 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified data including participant and disease characteristics and treatment outcomes will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Impact of Endoscopic Pancreatic Duct Decompression: A Pilot Study
- ClinicalTrials.gov ID
- NCT07810309
- Acronym / sponsor ID
- 26-005624
- Conditions
- Chronic Pancreatitis
- Keywords
- chronic pancreatitis, ERCP, pancreatic endocrine function, pancreatic exocrine function, diabetes, pancreatoscopy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Indiana University
- Study start
- 30 Oct 2026 (actual)
- Primary completion
- Sep 2029 (estimated)
- Study completion
- Mar 2030 (estimated)
- First posted
- 9 Sep 2026 (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.
This study is a pilot study evaluating the impact of clearing out the pancreatic duct in patients with chronic pancreatitis who have a blockage in their pancreatic duct. While we typically perform procedures with an endoscope (a long flexible tube with a camera that goes through the mouth to reach the small intestine) to relieve a pancreatic duct blockage in patients with chronic pancreatitis who have pain and have a blockage, we do not know how relieving this blockage improves pancreatic function. Therefore, we are performing a preliminary study where participants will be randomized to either receiving an endoscopy or not undergoing an endoscopy. This will provide some background data to help inform us whether we should perform a larger study in the future to answer this question.
Detailed description
This single-center randomized controlled trial will compare endoscopic pancreatic duct decompression with medical management alone for the treatment of pancreatic duct obstruction in patients with minimally symptomatic chronic pancreatitis. Utilizing mixed-meal tolerance testing, endocrine function will be assessed at baseline and 6-months post-randomization. We hypothesize that rigorous metabolic testing using mixed-meal tolerance testing at baseline and 6-months post-randomization will be feasible.
The study intervention entails endoscopic pancreatic duct decompression which entails endoscopic retrograde cholangiopancreatography (ERCP) with or without extracorporeal shock wave lithotripsy (ESWL). Endoscopic treatment via ERCP ± ESWL will continue until pancreatic duct decompression is achieved. The control arm will receive medical management alone, defined as standard of care treatment per the discretion of the treating pancreatologist.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized-controlled trial
| Arm | Type | Receives |
|---|---|---|
| Endoscopic pancreatic duct decompression (Intervention Arm) | Experimental | Procedure: Endoscopic pancreatic duct decompressionParticipants in the intervention arm will receive endoscopic pancreatic duct decompression. |
| No endoscopic intervention (Control Arm) | No intervention | –The control arm will receive medical management alone, defined as standard of care treatment per the discretion of the treating pancreatologist. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged ≥ 18
- Chronic pancreatitis as defined by Cambridge grade 3 or 4 (3: > 3 abnormal side branches; 4: abnormal main duct and branches) pancreatic ductal changes and/or parenchymal and/or intraductal calcifications (chronic calcific pancreatitis) by CT Scan or MRI/MRCP24
- Minimally symptomatic:
Key exclusion criteria (12 listed)
- History of diabetes (defined as either a HbA1c ≥ 6.5 % or a fasting glucose ≥ 126 mg/dL)
- Pancreatic duct obstruction limited to the tail of pancreas
- Surgically altered forgot anatomy prohibitive of ERCP with standard techniques (e.g Billroth II, Roux-en-y gastric bypass, pancreaticoduodenectomy)
- Prior pancreatic surgery
- Pancreatic head mass or suspicion for pancreatic malignancy
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 |
|---|---|---|
| Endoscopic pancreatic duct decompressionThe study intervention is endoscopic pancreatic duct decompression, which will consist of endoscopic retrograde cholangiopancreatography (ERCP) with or without extracorporeal shockwave lithotripsy (ESWL). Treatment via ERCP +/- ESWL can be continued for multiple treatment sessions until the pancreatic duct has been decompressed, defined as complete resolution of the PD stricture (defined as > 90% resolution of the stenosis on pancreatography) and/or complete stone clearance (> 90% removal of PD stones) of any PD stones. Pancreatoscopy-guided lithotripsy can be performed during ERCP as well to help aid in stricture or stone therapy. | Procedure or surgery | Endoscopic pancreatic duct decompression (Intervention Arm) |
Primary outcome
Feasibility of performing randomized-controlled trial in patients with minimally symptomatic chronic pancreatitis to assess metabolic function as defined via enrollment ratio, retention rate, and assessment completion rate.
Time frame: From enrollment to 6 months post-randomization
Feasibility will be defined as follows: For the study enrollment ratio, the total number of participants referred will form the denominator for the enrollment ratio, while the number of enrolled will form the numerator for the enrollment ratio. A 50% enrollment ratio will be indicative of feasibility. Retention will be determined by the proportion of enrolled participants who remain in the study until completion of endotherapy and the end of assessment period. A 75% retention rate will be indicative of feasibility. Assessment completion will be defined as completion of all baseline assessments and 6-months post-randomization assessments, including all metabolic tests. Participants who complete all assessments represent the numerators in the assessment completion ratio with the number of participants enrolled serving as the denominator in the assessment completion ratio. A 70% completion rate will indicate feasibility.
2 secondary outcomes
Impact of pancreatic duct decompression on pancreatic endocrine function as measured via insulin secretion.
Time frame: From enrollment to 6 months post-randomization
Impact of pancreatic duct decompression on pancreatic exocrine function as measured by fecal elastase.
Time frame: From enrollment to 6-months post-randomization
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 3 Nov 2026.
- Individual participant dataSharing planned: Yes. Deidentified data including participant and disease characteristics and treatment outcomes will be shared.
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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.
Samuel Han, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Endoscopic pancreatic duct decompression in people with Chronic Pancreatitis, run by Mayo Clinic at 1 site in United States.
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 8 inclusion and 12 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 3 Nov 2026. 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 United States. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Luis Ospina, BS (507-538-1827, OspinaVelasquez.Luis@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of performing randomized-controlled trial in patients with minimally symptomatic chronic pancreatitis to assess metabolic function as defined via enrollment ratio, retention rate, and assessment completion rate. (time frame: From enrollment to 6 months post-randomization). 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 3 Nov 2026.