Ampullary Cancer, Distal Extrahepatic Cholangiocarcinoma, Duodenal Cancer, Pancreas Cancer, Pancreas Neuroendocrine Tumor, Pancreatic Cancer, Pancreatitis
Conditions
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.
Interventions
DRUGPlacebo
Placebo capsules contain pharmaceutical-grade lactose monohydrate NF, a naturally occurring disaccharide of galactose bound to glucose.
DRUGPantoprazole
The study will use commercial supply.
Sponsors
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Delayed Gastric Emptying as Measured by the International Study Group of Pancreatic Surgery (ISGPS) Criteria | Through 90 days after surgery | -Will be coded as yes and no |
| Number of Participants With Delayed Gastric Emptying as Measured by Modified Accordion Grading System (MAGS) | Through 90 days after surgery | -Will be coded as yes and no |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Surgical Complication(s) Defined by the Modified Accordion Grading System (MAGS) | Through 90 days after surgery | Surgical complication is defined by the Modified Accordion Grading System, coded as yes and no. |
| Kaplan-Meier Estimated 90-days Marginal Ulcer-free Survival (MUFS) Probability | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo -Visually equivalent placebo once daily from postoperative day 1 and continued for 10 doses or until the day of discharge (whichever is earlier). | 21 |
| Proton Pump Inhibitor -Pantoprazole once daily from postoperative day 1 and continued for 10 doses or until the day of discharge (whichever is earlier). | 20 |
| Unassigned Arm For patients who were enrolled but did not get randomized or receive any treatment. | 15 |
| Total | 56 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Attending physician did not order medication for patient - did not start treatment | 0 | 0 | 1 |
| Overall Study | Death - did not start treatment | 3 | 0 | 0 |
| Overall Study | Determined to be ineligible - did not start treatment | 0 | 0 | 7 |
| Overall Study | Disease progression - did not start treatment | 0 | 0 | 5 |
| Overall Study | Had a total gastrectomy - did not start treatment | 0 | 0 | 1 |
| Overall Study | Other complicating disease | 2 | 1 | 0 |
| Overall Study | Patient was NPO with NGT, could not receive oral medication - did not start treatment | 0 | 0 | 1 |
| Overall Study | Patient was ordered NPO and had NGT placed. | 0 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 2 | 0 |
Baseline characteristics
| Characteristic | Placebo | Total | Unassigned Arm | Proton Pump Inhibitor |
|---|---|---|---|---|
| Age, Continuous | 69 years | 67 years | 62 years | 67.5 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 21 Participants | 56 Participants | 15 Participants | 20 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 20 Participants | 55 Participants | 15 Participants | 20 Participants |
| Region of Enrollment United States | 21 participants | 56 participants | 15 participants | 20 participants |
| Sex: Female, Male Female | 9 Participants | 24 Participants | 6 Participants | 9 Participants |
| Sex: Female, Male Male | 12 Participants | 32 Participants | 9 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 3 / 21 | 0 / 20 | 0 / 15 |
| other Total, other adverse events | 0 / 18 | 0 / 20 | 0 / 0 |
| serious Total, serious adverse events | 0 / 18 | 0 / 20 | 0 / 0 |
Outcome results
Primary
Number of Participants With Delayed Gastric Emptying as Measured by Modified Accordion Grading System (MAGS)
-Will be coded as yes and no
Time frame: Through 90 days after surgery
Population: Three participants who were randomized to the Placebo arm died prior to receiving any treatment and are not included in this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Participants With Delayed Gastric Emptying as Measured by Modified Accordion Grading System (MAGS) | 3 Participants |
| Proton Pump Inhibitor | Number of Participants With Delayed Gastric Emptying as Measured by Modified Accordion Grading System (MAGS) | 6 Participants |
Primary
Number of Participants With Delayed Gastric Emptying as Measured by the International Study Group of Pancreatic Surgery (ISGPS) Criteria
-Will be coded as yes and no
Time frame: Through 90 days after surgery
Population: Three participants who were randomized to the Placebo arm died prior to receiving any treatment and are not included in this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Participants With Delayed Gastric Emptying as Measured by the International Study Group of Pancreatic Surgery (ISGPS) Criteria | 3 Participants |
| Proton Pump Inhibitor | Number of Participants With Delayed Gastric Emptying as Measured by the International Study Group of Pancreatic Surgery (ISGPS) Criteria | 6 Participants |
Secondary
Kaplan-Meier Estimated 90-days Marginal Ulcer-free Survival (MUFS) Probability
-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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Kaplan-Meier Estimated 90-days Marginal Ulcer-free Survival (MUFS) Probability | 0.9230769 proportion probability |
| Proton Pump Inhibitor | Kaplan-Meier Estimated 90-days Marginal Ulcer-free Survival (MUFS) Probability | 0.875 proportion probability |
Secondary
Number of Participants With Surgical Complication(s) Defined by the Modified Accordion Grading System (MAGS)
Surgical complication is defined by the Modified Accordion Grading System, coded as yes and no.
Time frame: Through 90 days after surgery
Population: Three participants who were randomized to the Placebo arm died prior to receiving any treatment and are not included in this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Participants With Surgical Complication(s) Defined by the Modified Accordion Grading System (MAGS) | 8 Participants |
| Proton Pump Inhibitor | Number of Participants With Surgical Complication(s) Defined by the Modified Accordion Grading System (MAGS) | 11 Participants |