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SpHincterotomy for Acute Recurrent Pancreatitis (SHARP)

Primary Purpose

Pancreatitis, Pancreas Divisum, Pancreatitis, Acute

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
ERCP with miES
EUS
Sponsored by
Oregon Health and Science University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatitis focused on measuring ERCP, Endoscopic retrograde cholangiopancreatography, pancreatitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Arkansas for Medical SciencesRecruiting
  • Keck Hospital of USCRecruiting
  • Cedars-SinaiRecruiting
  • UCSF Medical CenterRecruiting
  • Yale School of MedicineRecruiting
  • Emory University HospitalRecruiting
  • Northwestern UniversityRecruiting
  • Indiana UniversityRecruiting
  • Beth Israel Deaconess Medical CenterRecruiting
  • University of MinnesotaRecruiting
  • Saint Luke's Hospital SystemRecruiting
  • Dartmouth-Hitchcock Medical CenterRecruiting
  • University of Rochester
  • The Ohio State University - Wexner Medical CenterRecruiting
  • Oregon Health and Science UniversityRecruiting
  • University of Pittsburgh Medical CenterRecruiting
  • Medical University of South CarolinaRecruiting
  • Methodist Dallas Medical CenterRecruiting
  • University of VirginiaRecruiting
  • Virginia Mason Hospital & Seattle Medical CenterRecruiting
  • Health Sciences CentreRecruiting
  • Radboud University Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Experimental

Arm Label

EUS + Sham

EUS + ERCP with miES

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
July 24, 2018
Last Updated
July 29, 2022
Sponsor
Oregon Health and Science University
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT03609944
Brief Title
SpHincterotomy for Acute Recurrent Pancreatitis
Acronym
SHARP
Official Title
SpHincterotomy for Acute Recurrent Pancreatitis (SHARP Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 27, 2018 (Actual)
Primary Completion Date
February 1, 2025 (Anticipated)
Study Completion Date
September 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oregon Health and Science University
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatitis, Pancreas Divisum, Pancreatitis, Acute, Pancreatitis Idiopathic, Pancreas Inflamed
Keywords
ERCP, Endoscopic retrograde cholangiopancreatography, pancreatitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Subjects will be randomized 1:1 to either EUS+sham or EUS+ERCP with miES.
Masking
ParticipantOutcomes 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.
Allocation
Randomized
Enrollment
234 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
EUS + Sham
Arm Type
Sham Comparator
Arm Description
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.
Arm Title
EUS + ERCP with miES
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
ERCP with miES
Intervention Description
Endoscopic retrograde cholangiopancreatography with minor papilla endoscopic sphincterotomy
Intervention Type
Procedure
Intervention Name(s)
EUS
Intervention Description
Endoscopic ultrasound
Primary Outcome Measure Information:
Title
Reduce the risk of subsequent acute pancreatitis episodes by 33%
Description
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.
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.
Secondary Outcome Measure Information:
Title
To compare the incidence rate ratio of acute pancreatitis between treatment groups
Description
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.
Time Frame
Incidence rate will be assessed starting 30 days after treatment through a maximum follow-up of 48 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient must consent to be in the study and must have signed and dated an approved consent form. >18 years 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 At least one episode of acute pancreatitis within 24 months of enrollment Pancreas divisum confirmed by prior MRCP that is reviewed by an abdominal radiologist at the recruiting site. By physician assessment, there is no certain explanation for recurrent acute pancreatitis. 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: Prior minor papilla therapy (endoscopic or surgical) 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. Main pancreatic duct stricture* Presence of a structural etiology for acute pancreatitis, such as anomalous pancreatobiliary union, periampullary mass, or pancreatic mass lesion on imaging* Presence of a local complication from acute pancreatitis which requires pancreatogram Regular use of opioid medication for abdominal pain for the past three months Medication as the etiology for acute pancreatitis by physician assessment TWEAK score ≥ 4
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gregory Cote, MD, MS
Phone
503-494-5255
Email
coteg@ohsu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Heather Katcher
Phone
503-494-4107
Email
katcher@ohsu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gregory A Cote, MD, MS
Organizational Affiliation
Oregon Health and Science University
Official's Role
Study Chair
Facility Information:
Facility Name
University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alicia DeAguero
Phone
501-214-2102
Email
BADeaguero@uams.edu
First Name & Middle Initial & Last Name & Degree
Sumant Inamdar, MBBS, MPH
Facility Name
Keck Hospital of USC
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jessica Serna
Phone
323-409-6939
Email
SernaJ@USC.edu
First Name & Middle Initial & Last Name & Degree
James Buxbaum
Facility Name
Cedars-Sinai
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joseph Meza
Phone
805-823-5946
Email
Joseph.Meza@cshs.org
First Name & Middle Initial & Last Name & Degree
Srinivas Gaddam, MD
Facility Name
UCSF Medical Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Janille Miranda
Phone
415-476-4882
Email
Janille.Miranda@ucsf.edu
First Name & Middle Initial & Last Name & Degree
Sun-Chuan Dai, MD
Facility Name
Yale School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christina Rose
Phone
203-984-4007
Email
christina.rose@yale.edu
First Name & Middle Initial & Last Name & Degree
Priya A. Jamidar, MD
Facility Name
Emory University Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ambreen Merchant
Phone
404-727-6278
Email
amerc26@emory.edu
First Name & Middle Initial & Last Name & Degree
Field F. Willingham, MD
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jordan Wood
Phone
312-926-4390
Email
jordan.wood1@northwestern.edu
First Name & Middle Initial & Last Name & Degree
Rajesh Keswani, MD
Facility Name
Indiana University
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Suzette Schmidt
Phone
317-948-8104
Email
suschmid@iu.edu
First Name & Middle Initial & Last Name & Degree
Evan Fogel, MD
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roya Dastjerdi
Phone
617-667-4046
Email
rdastjer@bidmc.harvard.edu
First Name & Middle Initial & Last Name & Degree
Douglas Pleskow, MD
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ghislaine Feussom
Phone
612-626-3636
Email
feuss001@umn.edu
First Name & Middle Initial & Last Name & Degree
Martin Freeman, MD
Facility Name
Saint Luke's Hospital System
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jodi Harkness
Phone
816-932-0352
Email
jharkness@saint-lukes.org
First Name & Middle Initial & Last Name & Degree
Srinivas Jonnalagadda, MD
Facility Name
Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Penny Doughty
Phone
603-653-6048
Email
Penny.J.Doughty@hitchcock.org
First Name & Middle Initial & Last Name & Degree
Timothy Gardner, MD
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14627
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Krystle Bittner
Phone
585-276-5539
Email
Krystle_Bittner@URMC.Rochester.edu
First Name & Middle Initial & Last Name & Degree
Truptesh Kothari, MD, MS
Facility Name
The Ohio State University - Wexner Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brianna Conley
Phone
614-366-4495
Email
brianna.conley@osumc.edu
First Name & Middle Initial & Last Name & Degree
Darwin Conwell, MD
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Czarinna Posadas
Phone
503-494-2278
Email
posadasc@ohsu.edu
First Name & Middle Initial & Last Name & Degree
Gregory Cote, MD, MS
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tina Tomko
Phone
412-647-1120
Email
tomkot@upmc.edu
First Name & Middle Initial & Last Name & Degree
Dhiraj Yadav, MD
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29407
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Haley Nitchie
Phone
843-876-0487
Email
Nitchie@musc.edu
First Name & Middle Initial & Last Name & Degree
Badih J Elmunzer, MD
Facility Name
Methodist Dallas Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75203
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Esmeralda Martinez
Phone
214-947-4066
Email
EsmeraldaMartinez@mhd.com
First Name & Middle Initial & Last Name & Degree
Prashant Kedia, MD
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sharon Foster
Email
SLF9H@hscmail.mcc.virginia.edu
First Name & Middle Initial & Last Name & Degree
Andrew Wang, MD
Facility Name
Virginia Mason Hospital & Seattle Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katrina Magbitang
Phone
202-341-1406
Email
KatrinaAnn.Magbitang@VirginiaMason.org
First Name & Middle Initial & Last Name & Degree
Andrew Ross, MD
Facility Name
Health Sciences Centre
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3A 1R9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Diane McAlpine
Phone
204-787-1643
Email
DMcAlpine@hsc.mb.ca
First Name & Middle Initial & Last Name & Degree
Dana Moffatt, MD
Facility Name
Radboud University Medical Center
City
Nijmegen
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erwin van Geenen
Email
Erwin.vanGeenen@radboudumc.nl
First Name & Middle Initial & Last Name & Degree
Erwin van Geenen

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31404020
Citation
Cote GA, Durkalski-Mauldin VL, Serrano J, Klintworth E, Williams AW, Cruz-Monserrate Z, Arain M, Buxbaum JL, Conwell DL, Fogel EL, Freeman ML, Gardner TB, van Geenen E, Groce JR, Jonnalagadda SS, Keswani RN, Menon S, Moffatt DC, Papachristou GI, Ross A, Tarnasky PR, Wang AY, Wilcox CM, Hamilton F, Yadav D; SHARP Consortium. SpHincterotomy for Acute Recurrent Pancreatitis Randomized Trial: Rationale, Methodology, and Potential Implications. Pancreas. 2019 Sep;48(8):1061-1067. doi: 10.1097/MPA.0000000000001370.
Results Reference
derived
Links:
URL
https://www.pancreasdivisum.com
Description
study trial website

Learn more about this trial

SpHincterotomy for Acute Recurrent Pancreatitis

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