Role of Proton Pump Inhibitors on the Postoperative Course Following Pancreaticoduodenectomy
Primary Purpose
Pancreatic Cancer, Pancreas Cancer, Ampullary Cancer
Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Placebo
Pantoprazole
Sponsored by
About this trial
This is an interventional supportive care trial for Pancreatic Cancer
Eligibility Criteria
Inclusion Criteria:
- All consecutive patients who will undergo pancreaticoduodenectomy with gastric/biliary reconstruction performed as definitive management for a benign or malignant disease at Washington University/Barnes-Jewish Hospital.
- At least 18 years of age.
- Ability to understand and willingness to sign an IRB approved written informed consent document.
Exclusion Criteria:
- <18 years of age
Sites / Locations
- Washington University School of MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Placebo
Proton pump inhibitor
Arm Description
-Visually equivalent placebo once daily from postoperative day 1 and continued for 10 doses or until the day of discharge (whichever is earlier).
-Pantoprazole once daily from postoperative day 1 and continued for 10 doses or until the day of discharge (whichever is earlier).
Outcomes
Primary Outcome Measures
Incidence of delayed gastric emptying as measured by the International Study Group of Pancreatic Surgery (ISGPS) criteria
-Will be coded as yes and no
Incidence of delayed gastric emptying as measured by Modified Accordion Grading System (MAGS)
-Will be coded as yes and no
Secondary Outcome Measures
Incidence of surgical complication defined by the Modified Accordion Grading System (MAGS)
Surgical complication is defined by the modified accordion grading system, coded as yes and no.
Marginal ulcer-free survival (MUFS)
-MUFS is defined as the days from the date of randomization to diagnosis of a marginal ulcer. The patients without marginal ulcer are censored at the date of last follow-up.
Full Information
NCT ID
NCT05251233
First Posted
February 11, 2022
Last Updated
June 22, 2023
Sponsor
Washington University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT05251233
Brief Title
Role of Proton Pump Inhibitors on the Postoperative Course Following Pancreaticoduodenectomy
Official Title
Evaluation of the Role of Proton Pump Inhibitors on the Postoperative Course Following Pancreaticoduodenectomy
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 21, 2022 (Actual)
Primary Completion Date
July 31, 2025 (Anticipated)
Study Completion Date
July 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to prospectively determine the effects of administering proton pump inhibitors (PPIs) following pancreaticoduodenectomy on postoperative outcomes. The findings of this study will help in avoiding the widespread use of PPIs during the immediate postoperative period following pancreatic surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer, Pancreas Cancer, Ampullary Cancer, Pancreas Neuroendocrine Tumor, Pancreatitis, Distal Extrahepatic Cholangiocarcinoma, Duodenal Cancer
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
240 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
-Visually equivalent placebo once daily from postoperative day 1 and continued for 10 doses or until the day of discharge (whichever is earlier).
Arm Title
Proton pump inhibitor
Arm Type
Active Comparator
Arm Description
-Pantoprazole once daily from postoperative day 1 and continued for 10 doses or until the day of discharge (whichever is earlier).
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo capsules contain pharmaceutical-grade lactose monohydrate NF, a naturally occurring disaccharide of galactose bound to glucose.
Intervention Type
Drug
Intervention Name(s)
Pantoprazole
Intervention Description
The study will use commercial supply.
Primary Outcome Measure Information:
Title
Incidence of delayed gastric emptying as measured by the International Study Group of Pancreatic Surgery (ISGPS) criteria
Description
-Will be coded as yes and no
Time Frame
Through 90 days after surgery
Title
Incidence of delayed gastric emptying as measured by Modified Accordion Grading System (MAGS)
Description
-Will be coded as yes and no
Time Frame
Through 90 days after surgery
Secondary Outcome Measure Information:
Title
Incidence of surgical complication defined by the Modified Accordion Grading System (MAGS)
Description
Surgical complication is defined by the modified accordion grading system, coded as yes and no.
Time Frame
Through 90 days after surgery
Title
Marginal ulcer-free survival (MUFS)
Description
-MUFS is defined as the days from the date of randomization to diagnosis of a marginal ulcer. The patients without marginal ulcer are censored at the date of last follow-up.
Time Frame
Through 90 days after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All consecutive patients who will undergo pancreaticoduodenectomy with gastric/biliary reconstruction performed as definitive management for a benign or malignant disease at Washington University/Barnes-Jewish Hospital.
At least 18 years of age.
Ability to understand and willingness to sign an IRB approved written informed consent document.
Exclusion Criteria:
<18 years of age
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Natasha Leigh, M.D.
Phone
314-362-7147
Email
leigh@wustl.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Natash Leigh, M.D.
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Natash Leigh, M.D.
Phone
314-362-7147
Email
leigh@wustl.edu
First Name & Middle Initial & Last Name & Degree
Natasha Leigh, M.D.
First Name & Middle Initial & Last Name & Degree
Ryan Fields, M.D., FACS
First Name & Middle Initial & Last Name & Degree
William Hawkins, M.D., FACS
First Name & Middle Initial & Last Name & Degree
Dominic Sanford, M.D., MPHS, FACS
First Name & Middle Initial & Last Name & Degree
Adeel Khan, M.D., MPH, FACS
First Name & Middle Initial & Last Name & Degree
Maria Majella Doyle, M.D., MBA, FACS
First Name & Middle Initial & Last Name & Degree
William Chapman, M.D., FACS
First Name & Middle Initial & Last Name & Degree
Esther Lu, Ph.D.
First Name & Middle Initial & Last Name & Degree
Chet Hammill, M.D., MCR, FACS
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
http://www.siteman.wustl.edu
Description
Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine
Learn more about this trial
Role of Proton Pump Inhibitors on the Postoperative Course Following Pancreaticoduodenectomy
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