NCT03609944

SpHincterotomy for Acute Recurrent Pancreatitis

SpHincterotomy for Acute Recurrent Pancreatitis (SHARP Trial)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 181 (actual)
• Sponsor: Oregon Health and Science University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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).

Conditions

• Pancreatitis
• Pancreas Divisum
• Pancreatitis, Acute
• Pancreatitis Idiopathic
• Pancreas Inflamed

Interventions

Type	Name	Description
PROCEDURE	ERCP with miES	Endoscopic retrograde cholangiopancreatography with minor papilla endoscopic sphincterotomy
PROCEDURE	EUS	Endoscopic ultrasound

Timeline

• Start date: 2018-09-27
• Primary completion: 2025-02-28
• Completion: 2025-08-31
• First posted: 2018-08-01
• Last updated: 2025-12-30
• Results posted: 2025-12-30

Locations

21 sites across 2 countries: United States, Canada