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Investigator and study team chose to end study early.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | -Visually equivalent placebo once daily from postoperative day 1 and continued for 10 doses or until the day of discharge (whichever is earlier). |
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| Proton pump inhibitor | Active Comparator | -Pantoprazole once daily from postoperative day 1 and continued for 10 doses or until the day of discharge (whichever is earlier). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Placebo capsules contain pharmaceutical-grade lactose monohydrate NF, a naturally occurring disaccharide of galactose bound to glucose. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | Through 90 days after surgery |
| Number of Participants With Delayed Gastric Emptying as Measured by Modified Accordion Grading System (MAGS) | -Will be coded as yes and no | Through 90 days after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Through 90 days after surgery |
| Kaplan-Meier Estimated 90-days Marginal Ulcer-free Survival (MUFS) Probability |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Natasha Leigh-Matijakovich, M.D. | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
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| Label | URL |
|---|---|
| Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | -Visually equivalent placebo once daily from postoperative day 1 and continued for 10 doses or until the day of discharge (whichever is earlier). |
| FG001 | Proton Pump Inhibitor |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 25, 2023 |
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| Pantoprazole | Drug | The study will use commercial supply. |
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-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. |
| Through 90 days after surgery |
-Pantoprazole once daily from postoperative day 1 and continued for 10 doses or until the day of discharge (whichever is earlier).
| FG002 | Unassigned Arm | For patients who were enrolled but did not get randomized or receive any treatment. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | -Visually equivalent placebo once daily from postoperative day 1 and continued for 10 doses or until the day of discharge (whichever is earlier). |
| BG001 | Proton Pump Inhibitor | -Pantoprazole once daily from postoperative day 1 and continued for 10 doses or until the day of discharge (whichever is earlier). |
| BG002 | Unassigned Arm | For patients who were enrolled but did not get randomized or receive any treatment. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Three participants who were randomized to the Placebo arm died prior to receiving any treatment and are not included in this outcome measure. | Posted | Count of Participants | Participants | Through 90 days after surgery |
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| Primary | Number of Participants With Delayed Gastric Emptying as Measured by Modified Accordion Grading System (MAGS) | -Will be coded as yes and no | Three participants who were randomized to the Placebo arm died prior to receiving any treatment and are not included in this outcome measure. | Posted | Count of Participants | Participants | Through 90 days after surgery |
|
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| 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. | Three participants who were randomized to the Placebo arm died prior to receiving any treatment and are not included in this outcome measure. | Posted | Count of Participants | Participants | Through 90 days after surgery |
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| 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. | Posted | Number | 95% Confidence Interval | proportion probability | Through 90 days after surgery |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | -Visually equivalent placebo once daily from postoperative day 1 and continued for 10 doses or until the day of discharge (whichever is earlier). | 3 | 21 | 0 | 18 | 0 | 18 |
| EG001 | Proton Pump Inhibitor | -Pantoprazole once daily from postoperative day 1 and continued for 10 doses or until the day of discharge (whichever is earlier). | 0 | 20 | 0 | 20 | 0 | 20 |
| EG002 | Unassigned Arm | For patients who were enrolled but did not get randomized or receive any treatment. | 0 | 15 | 0 | 0 | 0 | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Natasha Leigh-Matijakovich, M.D. | Washington University School of Medicine | 314-362-7147 | leigh@wustl.edu |
| Dec 18, 2024 |
| Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| D010195 | Pancreatitis |
| D004379 | Duodenal Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D005767 | Gastrointestinal Diseases |
| D004378 | Duodenal Diseases |
| D007410 | Intestinal Diseases |
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| ID | Term |
|---|---|
| D000077402 | Pantoprazole |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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