Trial Outcomes & Findings for Role of Proton Pump Inhibitors on the Postoperative Course Following Pancreaticoduodenectomy (NCT NCT05251233)
NCT ID: NCT05251233
Last Updated: 2025-05-06
Results Overview
-Will be coded as yes and no
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
56 participants
Primary outcome timeframe
Through 90 days after surgery
Results posted on
2025-05-06
Participant Flow
Participant milestones
| Measure |
Placebo
-Visually equivalent placebo once daily from postoperative day 1 and continued for 10 doses or until the day of discharge (whichever is earlier).
|
Proton Pump Inhibitor
-Pantoprazole once daily from postoperative day 1 and continued for 10 doses or until the day of discharge (whichever is earlier).
|
Unassigned Arm
For patients who were enrolled but did not get randomized or receive any treatment.
|
|---|---|---|---|
|
Overall Study
STARTED
|
21
|
20
|
15
|
|
Overall Study
COMPLETED
|
14
|
16
|
0
|
|
Overall Study
NOT COMPLETED
|
7
|
4
|
15
|
Reasons for withdrawal
| Measure |
Placebo
-Visually equivalent placebo once daily from postoperative day 1 and continued for 10 doses or until the day of discharge (whichever is earlier).
|
Proton Pump Inhibitor
-Pantoprazole once daily from postoperative day 1 and continued for 10 doses or until the day of discharge (whichever is earlier).
|
Unassigned Arm
For patients who were enrolled but did not get randomized or receive any treatment.
|
|---|---|---|---|
|
Overall Study
Disease progression - did not start treatment
|
0
|
0
|
5
|
|
Overall Study
Determined to be ineligible - did not start treatment
|
0
|
0
|
7
|
|
Overall Study
Patient was NPO with NGT, could not receive oral medication - did not start treatment
|
0
|
0
|
1
|
|
Overall Study
Had a total gastrectomy - did not start treatment
|
0
|
0
|
1
|
|
Overall Study
Death - did not start treatment
|
3
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
0
|
|
Overall Study
Other complicating disease
|
2
|
1
|
0
|
|
Overall Study
Attending physician did not order medication for patient - did not start treatment
|
0
|
0
|
1
|
|
Overall Study
Patient was ordered NPO and had NGT placed.
|
0
|
1
|
0
|
Baseline Characteristics
Role of Proton Pump Inhibitors on the Postoperative Course Following Pancreaticoduodenectomy
Baseline characteristics by cohort
| Measure |
Placebo
n=21 Participants
-Visually equivalent placebo once daily from postoperative day 1 and continued for 10 doses or until the day of discharge (whichever is earlier).
|
Proton Pump Inhibitor
n=20 Participants
-Pantoprazole once daily from postoperative day 1 and continued for 10 doses or until the day of discharge (whichever is earlier).
|
Unassigned Arm
n=15 Participants
For patients who were enrolled but did not get randomized or receive any treatment.
|
Total
n=56 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
69 years
n=5 Participants
|
67.5 years
n=7 Participants
|
62 years
n=5 Participants
|
67 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
21 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
56 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
55 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
21 participants
n=5 Participants
|
20 participants
n=7 Participants
|
15 participants
n=5 Participants
|
56 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Through 90 days after surgeryPopulation: Three participants who were randomized to the Placebo arm died prior to receiving any treatment and are not included in this outcome measure.
-Will be coded as yes and no
Outcome measures
| Measure |
Placebo
n=18 Participants
-Visually equivalent placebo once daily from postoperative day 1 and continued for 10 doses or until the day of discharge (whichever is earlier).
|
Proton Pump Inhibitor
n=20 Participants
-Pantoprazole once daily from postoperative day 1 and continued for 10 doses or until the day of discharge (whichever is earlier).
|
|---|---|---|
|
Number of Participants With Delayed Gastric Emptying as Measured by the International Study Group of Pancreatic Surgery (ISGPS) Criteria
|
3 Participants
|
6 Participants
|
PRIMARY outcome
Timeframe: Through 90 days after surgeryPopulation: Three participants who were randomized to the Placebo arm died prior to receiving any treatment and are not included in this outcome measure.
-Will be coded as yes and no
Outcome measures
| Measure |
Placebo
n=18 Participants
-Visually equivalent placebo once daily from postoperative day 1 and continued for 10 doses or until the day of discharge (whichever is earlier).
|
Proton Pump Inhibitor
n=20 Participants
-Pantoprazole once daily from postoperative day 1 and continued for 10 doses or until the day of discharge (whichever is earlier).
|
|---|---|---|
|
Number of Participants With Delayed Gastric Emptying as Measured by Modified Accordion Grading System (MAGS)
|
3 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Through 90 days after surgeryPopulation: Three participants who were randomized to the Placebo arm died prior to receiving any treatment and are not included in this outcome measure.
Surgical complication is defined by the Modified Accordion Grading System, coded as yes and no.
Outcome measures
| Measure |
Placebo
n=18 Participants
-Visually equivalent placebo once daily from postoperative day 1 and continued for 10 doses or until the day of discharge (whichever is earlier).
|
Proton Pump Inhibitor
n=20 Participants
-Pantoprazole once daily from postoperative day 1 and continued for 10 doses or until the day of discharge (whichever is earlier).
|
|---|---|---|
|
Number of Participants With Surgical Complication(s) Defined by the Modified Accordion Grading System (MAGS)
|
8 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: Through 90 days after surgery-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.
Outcome measures
| Measure |
Placebo
n=13 Participants
-Visually equivalent placebo once daily from postoperative day 1 and continued for 10 doses or until the day of discharge (whichever is earlier).
|
Proton Pump Inhibitor
n=16 Participants
-Pantoprazole once daily from postoperative day 1 and continued for 10 doses or until the day of discharge (whichever is earlier).
|
|---|---|---|
|
Kaplan-Meier Estimated 90-days Marginal Ulcer-free Survival (MUFS) Probability
|
0.9230769 proportion probability
Interval 0.5663595 to 0.9887941
|
0.875 proportion probability
Interval 0.5859814 to 0.9671888
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 3 deaths
Proton Pump Inhibitor
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Unassigned Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Natasha Leigh-Matijakovich, M.D.
Washington University School of Medicine
Phone: 314-362-7147
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place