Pancreatic Endotherapy for Refractory Chronic Pancreatitis

NCT04232670 | Completed Results DMC

• 1 other identifier: Pro00087299
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to evaluate whether endoscopic ultrasound (EUS) only versus EUS + endoscopic retrograde cholangiopancreatography (ERCP) with pancreatic endotherapy reduces pain in the treatment of chronic pancreatitis with pancreatic duct obstruction.

Conditions

Pancreatic Duct Stone; Pancreatic Duct Stricture; Pancreatic Duct Dilatation

Keywords

pancreas; pancreatic duct; ductal stone; duct stricture; ERCP; pancreatic duct obstruction; duct calcification

Outcome Measures

Primary Outcomes (1)

• Percent Change in Average Daily Pain Score on the Numeric Rating Scale

  The percent change in average daily pain score from the daily diaries during the 14-day period preceding the 90-day assessment, compared to the average daily pain reported during the 14-day run-in. The investigators employed the standardized 11-point Numeric Rating Scale (NRS) to capture average daily pain with the empirically-supported anchors of 0=No Pain and 10=Worst Pain Imaginable.

  Day -14 to Day 90

Study Arms (2)

EUS + SHAM

SHAM COMPARATOR

All subjects will undergo anesthesia administered sedation and endoscopic ultrasound (EUS). The endoscopist will assess the pancreas for parenchymal and ductal features of chronic pancreatitis and confirm the absence of exclusion criteria (such as the presence of an occult pancreatobiliary malignancy).

Procedure: EUS + SHAM

EUS + Pancreatic Endotherapy

EXPERIMENTAL

If randomized to ERCP with pancreatic endotherapy, the endoscopist will proceed with this intervention immediately following the completion of EUS and treatment allocation (during the same anesthesia). Pancreatic endotherapy may include any or all of the following maneuvers: pancreatic endoscopic sphincterotomy, stricture dilation using a bougie or hydrostatic balloon catheter, pancreatic stone extraction with or without mechanical or electrohydraulic lithotripsy, extracorporeal shock wave lithotripsy, and stent placement. Overall technical success will be defined by the ability to insert at least one pancreatic stent across the dominant main pancreatic duct obstruction. Technical success for pancreatic stone treatment will be defined by the ability to remove all fluoroscopically visible main pancreatic duct stones.

Procedure: EUS + Pancreatic Endotherapy

Interventions

EUS + SHAM PROCEDURE

Endoscopic Ultrasound

EUS + SHAM

EUS + Pancreatic Endotherapy PROCEDURE

Pancreatic endotherapy may include any or all of the following maneuvers: pancreatic endoscopic sphincterotomy, stricture dilation using a bougie or hydrostatic balloon catheter, pancreatic stone extraction with or without mechanical or electrohydraulic lithotripsy, extracorporeal shock wave lithotripsy, and stent placement.

EUS + Pancreatic Endotherapy

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 years
• Main pancreatic duct obstruction, defined by the presence of one or both of the following features:
• Main pancreatic duct calcification with upstream main duct dilation ≥6mm.
• Main pancreatic duct stricture, defined by the presence of main pancreatic duct narrowing with upstream main duct dilation ≥6mm.
• Baseline average abdominal pain score ≥4 during the run-in period, based on Ecological Momentary Assessment 11-point Numeric Rating Scale
• Ability to provide written, informed consent

You may not qualify if:

• Symptoms attributable to a pancreatic pseudocyst or walled off necrosis
• Clinical suspicion of pancreatobiliary malignancy\*
• Low probability of follow-up to complete study objectives
• Pregnancy or incarceration
• Medical comorbidities that contraindicate the performance of ERCP
• Previous pancreatic endotherapy
• Current Opioid Misuse Measure score ≥9
• Does not have access to a mobile phone \* Pancreatobiliary malignancy

Sponsors & Collaborators

• Oregon Health and Science University: lead
• United States Department of Defense: collaborator

Study Sites (2)

Oregon Health & Science University

Portland, Oregon, 97035, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Interventions

salicylhydroxamic acid

Limitations and Caveats

Small sample size due to recruitment challenges \- It is difficult to recruit for the sham arm because endotherapy is widely utilized in clinical practice and advocated by expert consensus. Patients with painful chronic pancreatitis are disabled by their disease and often keen to try something even when risks are fixed and benefit unpredictable.

Results Point of Contact

• Title: Gregory Cote
• Organization: Oregon Health and Science University

coteg@ohsu.edu

503-494-4373

Study Officials

• Gregory Cote, MD, MS

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: In addition to the participant and the investigator assessing outcomes, study coordinators involved in collecting outcomes data will be masked to the treatment assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 6, 2019
• First Posted: January 18, 2020
• Study Start: October 9, 2020
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: September 24, 2025
• Results First Posted: September 24, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)