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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03609944
Other study ID # 1922
Secondary ID U01DK116743
Status Recruiting
Phase N/A
First received
Last updated
Start date September 27, 2018
Est. completion date September 1, 2027

Study information

Verified date November 2023
Source Oregon Health and Science University
Contact Gregory Cote, MD, MS
Phone 503-494-5255
Email coteg@ohsu.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine if a procedure called Endoscopic Retrograde CholangioPancreatography (ERCP) with sphincterotomy reduces the risk of pancreatitis or the number of recurrent pancreatitis episodes in patients with pancreas divisum. ERCP with sphincterotomy is a procedure where doctors used a combination of x-rays and an endoscope (a long flexible lighted tube) to find the opening of the duct where fluid drains out of the pancreas. People who have been diagnosed with pancreas divisum, have had at least two episodes of pancreatitis, and are candidates for the ERCP with sphincterotomy procedure may be eligible to participate. Participants will be will be randomly assigned to either have the ERCP with sphincterotomy procedure, or to have a "sham" procedure. Participants will have follow up visits 30 days after the procedure, 6 months after the procedure, and continuing every 6 months until a maximum follow-up period of 48 months.


Description:

This is a sham-controlled, single blinded with a blinded outcome assessment, multi-center, randomized clinical trial of endoscopic retrograde cholangiopancreatography (ERCP) with minor papilla endoscopic sphincterotomy (miES) for the treatment of recurrent acute pancreatitis (RAP) with pancreas divisum. ERCP with miES is often offered in clinical practice to patients with RAP, pancreas divisum, and no other clear risk factors for their acute pancreatitis episodes. The hypothesis is that obstruction at the level of the minor papilla is one cause of RAP in pancreas divisum; miES will relieve the obstruction, thereby reducing the risk of a recurrent attack(s) of acute pancreatitis. The trial requires a total sample size of approximately 234 subjects, and a planned enrollment period of approximately 3.5 years with total planned study duration of 5 years (minimum follow-up of 6 months, maximum follow-up of 48 months).


Recruitment information / eligibility

Status Recruiting
Enrollment 234
Est. completion date September 1, 2027
Est. primary completion date February 1, 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Patient must consent to be in the study and must have signed and dated an approved consent form. 2. >18 years 3. Two or more episodes of acute pancreatitis, with each episode meeting two of the following three criteria: - abdominal pain consistent with acute pancreatitis (acute onset of a persistent, severe, epigastric pain often radiating to the back) - serum lipase activity (or amylase activity) at least three times greater than the upper limit of normal - characteristic findings of acute pancreatitis on CECT, MRI or transabdominal ultrasonography 4. At least one episode of acute pancreatitis within 24 months of enrollment 5. Pancreas divisum confirmed by prior MRCP that is reviewed by an abdominal radiologist at the recruiting site. 6. By physician assessment, there is no certain explanation for recurrent acute pancreatitis. 7. Subjects must be able to fully understand and participate in all aspects of the study, including completion of questionnaires and telephone interviews, in the opinion of the clinical investigator Exclusion Criteria: 1. Prior minor papilla therapy (endoscopic or surgical) 2. Calcific chronic pancreatitis, defined as parenchymal or ductal calcifications identified on computed tomography or magnetic resonance imaging scan that is reviewed by an expert radiologist at the recruiting site. 3. Main pancreatic duct stricture* 4. Presence of a structural etiology for acute pancreatitis, such as anomalous pancreatobiliary union, periampullary mass, or pancreatic mass lesion on imaging* 5. Presence of a local complication from acute pancreatitis which requires pancreatogram 6. Regular use of opioid medication for abdominal pain for the past three months 7. Medication as the etiology for acute pancreatitis by physician assessment 8. TWEAK score = 4

Study Design


Intervention

Procedure:
ERCP with miES
Endoscopic retrograde cholangiopancreatography with minor papilla endoscopic sphincterotomy
EUS
Endoscopic ultrasound

Locations

Country Name City State
Canada Health Sciences Centre Winnipeg Manitoba
Netherlands Radboud University Medical Center Nijmegen
United States Emory University Hospital Atlanta Georgia
United States Beth Israel Deaconess Medical Center Boston Massachusetts
United States Medical University of South Carolina Charleston South Carolina
United States University of Virginia Charlottesville Virginia
United States Northwestern University Chicago Illinois
United States The Ohio State University - Wexner Medical Center Columbus Ohio
United States Methodist Dallas Medical Center Dallas Texas
United States Indiana University Indianapolis Indiana
United States Saint Luke's Hospital System Kansas City Missouri
United States Dartmouth-Hitchcock Medical Center Lebanon New Hampshire
United States University of Arkansas for Medical Sciences Little Rock Arkansas
United States Cedars-Sinai Los Angeles California
United States Keck Hospital of USC Los Angeles California
United States University of Minnesota Minneapolis Minnesota
United States Yale School of Medicine New Haven Connecticut
United States University of Pittsburgh Medical Center Pittsburgh Pennsylvania
United States Oregon Health and Science University Portland Oregon
United States University of Rochester Rochester New York
United States UCSF Medical Center San Francisco California
United States Virginia Mason Hospital & Seattle Medical Center Seattle Washington

Sponsors (2)

Lead Sponsor Collaborator
Oregon Health and Science University National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Countries where clinical trial is conducted

United States,  Canada,  Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary Reduce the risk of subsequent acute pancreatitis episodes by 33% To test this aim, compare the incidence of acute pancreatitis > 30 days after treatment allocation as the primary outcome measure, using the next attack of acute pancreatitis as a time-to-event outcome. This is a time-to-event outcome that is assessed starting 30 days after treatment through a maximum follow-up of 48 months.
Secondary To compare the incidence rate ratio of acute pancreatitis between treatment groups All randomized subjects will be followed longitudinally until study completion (minimum follow-up of six months, maximum follow-up of 48 months), even if acute pancreatitis occurs during follow-up. A secondary benefit of miES may be a reduction in acute pancreatitis frequency, defined as the incidence rate (episodes/time pre- and post-randomization). Since baseline incidence rate is a probable predictor of post-randomization incidence rate, the investigators will compare the incidence rate ratios between the two arms, keeping person-time equal between the pre/post periods. Incidence rate will be assessed starting 30 days after treatment through a maximum follow-up of 48 months.
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