Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Subjects will be randomized 1:1 to either EUS+sham or EUS+ERCP with miES.
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)
Masking Description
In addition to the participant and the investigator assessing outcomes, study coordinators involved in collecting outcomes data will be masked to the treatment assignment.

Arm Groups

ArmDescriptionAssigned Intervention
Sham Comparator
EUS + Sham
Subjects randomized to EUS + sham will undergo a diagnostic endoscopic ultrasound (EUS) under sedation. The physician investigator will not make any attempts to achieve minor papilla cannulation, but photo document the minor papilla using a duodenoscope. Diluted dye will be injected into the duodenum. A small caliber prophylactic pancreatic duct stent will be deposited into the duodenal lumen. These maneuvers are performed to minimize the risk of unmasking.
  • Procedure: EUS
    Endoscopic ultrasound
Experimental
EUS + ERCP with miES
Subjects randomized to EUS + ERCP with miES will undergo the procedure at the same time as endoscopic ultrasound (EUS), under sedation. Indomethacin (100 mg) will be administered rectally at the onset of the ERCP procedure in patients with no known allergy to indomethacin. The techniques used to perform the endoscopic retrograde cholangiopancreatography (ERCP)with miES (minor papilla endoscopic sphincterotomy) will be left to the discretion of the study endoscopist. The extent of sphincterotomy will be per the discretion of the treating endoscopist. Unless methylene blue (or similar chromoendoscopy agent such as indigo carmine) has already been used to facilitate minor papilla cannulation, diluted dye will be injected into the duodenum.
  • Procedure: ERCP with miES
    Endoscopic retrograde cholangiopancreatography with minor papilla endoscopic sphincterotomy
  • Procedure: EUS
    Endoscopic ultrasound

Recruiting Locations

University of Alabama at Birmingham
Birmingham, Alabama 35294
Contact:
Stacy Hyatt
stacyhyatt@uabmc.edu

More Details

Status
Recruiting
Sponsor
Gregory A. Cote

Study Contact

Gregory Cote, MD, MS
843-792-6999
cotea@musc.edu

Detailed 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).

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.