Clinical Trials Logo
  1. Home
  2. Pancreatitis, Acute
  3. NCT03609944

SpHincterotomy for Acute Recurrent Pancreatitis — SHARP  

Pancreatitis Clinical Trial

Official title:
SpHincterotomy for Acute Recurrent Pancreatitis (SHARP Trial)

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.

Clinical Trial 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). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03609944
Study type Interventional
Source Oregon Health and Science University
Contact Gregory Cote, MD, MS
Phone 503-494-5255
Email coteg@ohsu.edu
Status Recruiting
Phase N/A
Start date September 27, 2018
Completion date September 1, 2027
View Details
See also
  Status Clinical Trial Phase
Not yet recruiting NCT04652271 - International Pancreatic Surgery Outcomes Study - PancreasGroup.Org
Completed NCT01441492 - Pancreas Resection With and Without Drains N/A
Recruiting NCT02196935 - Los Angeles Prospective GI Biliary and EUS Series
Completed NCT01476995 - Prognostic Indicators as Provided by the EPIC ClearView N/A
Completed NCT01545167 - The North American Pancreatitis Study N/A
Completed NCT04168801 - Early Oral Refeeding in Mild Acute Pancreatitis N/A
Recruiting NCT03334708 - A Study of Blood Based Biomarkers for Pancreas Adenocarcinoma
Completed NCT01824186 - Trial Comparing Pain in Single-incision Laparoscopic Cholecystectomy Versus Conventional Laparoscopic Cholecystectomy N/A
Terminated NCT00428025 - Diclofenac for the Prevention of Post-ERCP Pancreatitis in Higher Risk Patients Phase 4
Completed NCT00639314 - Trial on the Evaluation of Pylorus-ring in Pancreaticoduodenectomy N/A
Recruiting NCT00160836 - Biliary Tissue Sampling Using a Cytology Brush or the GIUM Catheter Phase 1
Completed NCT00999232 - Assess the Effect of Erythromycin on the Rate of Success in Placement of a Self-propelled Feeding Tube Phase 4
Completed NCT00121901 - Does Glyceryl Nitrate Prevent Post-Endoscopic Retrograde Cholangiopancreaticography (ERCP) Pancreatitis? Phase 3
Terminated NCT00419549 - Efficacy Study of Glyceryl-Trinitrate Patch and Parecoxib (Valdecoxib) for the Prevention of Pancreatitis After Endoscopic Retrograde Cholangiopancreatography (ERCP) Phase 2/Phase 3
Active, not recruiting NCT05095831 - EUS Shear Wave for Solid Pancreatic Lesions.
Completed NCT03601325 - Acute Pancreatitis: Study of Possible Etiologies and Risk Factors Affecting Outcome
Withdrawn NCT02465138 - A Randomized Controlled Trial of IV Ketorolac to Prevent Post-ERCP Pancreatitis Phase 4
Not yet recruiting NCT06133023 - WONDER-02 Trial: Plastic Stent vs. Lumen-apposing Metal Stent for Pancreatic Pseudocysts N/A
Recruiting NCT02971475 - ESWL Versus ESWL and Endoscopic Treatment N/A
Recruiting NCT02305914 - Follow-up Study of Complications of Acute Pancreatitis N/A