SpHincterotomy for Acute Recurrent Pancreatitis (SHARP)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03609944|
Recruitment Status : Recruiting
First Posted : August 1, 2018
Last Update Posted : April 22, 2020
|Condition or disease||Intervention/treatment||Phase|
|Pancreatitis Pancreas Divisum Pancreatitis, Acute Pancreatitis Idiopathic Pancreas Inflamed||Procedure: ERCP with miES Procedure: EUS||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||234 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Subjects will be randomized 1:1 to either EUS+sham or EUS+ERCP with miES.|
|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.|
|Official Title:||SpHincterotomy for Acute Recurrent Pancreatitis (SHARP Trial)|
|Actual Study Start Date :||September 27, 2018|
|Estimated Primary Completion Date :||February 1, 2023|
|Estimated Study Completion Date :||September 1, 2023|
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.
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
- Reduce the risk of subsequent acute pancreatitis episodes by 33% [ Time Frame: This is a time-to-event outcome that is assessed starting 30 days after treatment through a maximum follow-up of 48 months. ]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.
- To compare the incidence rate ratio of acute pancreatitis between treatment groups [ Time Frame: Incidence rate will be assessed starting 30 days after treatment through a maximum follow-up of 48 months. ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03609944
|Contact: Gregory Cote, MD, MSfirstname.lastname@example.org|
|Study Chair:||Gregory A Cote, MD, MS||Medical University of South Carolina|