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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2021-06239 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| STUDY00022619 | Other Identifier | OHSU Knight Cancer Institute |
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low enrollment
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| Name | Class |
|---|---|
| Oregon Health and Science University | OTHER |
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This phase II trial studies the effect of botulinum toxin (Botox) in preventing postoperative pancreatic fistula after distal pancreatectomy. Postoperative pancreatic fistula (POPF) is a known risk of distal pancreatic surgery, in which leakage of pancreatic digestive liquids causes internal swelling that can be painful (termed inflammation). A valve-like muscle, called the Sphincter of Oddi, opens and closes, controlling the flow of digestive liquids from the liver (bile) and pancreas (pancreatic juice) to the small intestine (duodenum). After surgery, the Sphincter of Oddi may act to block the flow of normal pancreatic secretions, causing secretions to leak into the abdomen resulting in POPF. Botox is a drug that can cause paralysis of muscles. Giving an injection of Botox into the sphincter of Oddi before distal pancreatic surgery may reduce leakage of digestive fluids and potential POPF.
PRIMARY OBJECTIVE:
I. Evaluate the efficacy of pre-operative botulinum toxin type A (BTX) injection compared to no therapy for the prevention of clinically relevant POPF.
SECONDARY OBJECTIVES:
I. Evaluate the safety of pre-operative BTX injection into the Sphincter of Oddi.
II. Evaluate the efficacy of pre-operative BTX injection compared to no therapy for the prevention of all POPF.
EXPLORATORY OBJECTIVES:
I. Using a historical population matched for potential confounding clinicopathologic variables, evaluate differences in POPF.
II. Using a historical population matched for potential confounding clinicopathologic variables, evaluate differences in clinically relevant POPF (crPOPF).
III. Using a historical population matched for potential confounding clinicopathologic variables, evaluate differences in postoperative length of hospital stay.
IV. Using a historical population matched for potential confounding clinicopathologic variables, evaluate differences in rate of Clavien-Dindo grade III or greater complications.
V. Using a historical population matched for potential confounding clinicopathologic variables, evaluate differences in rate of percutaneous drainage.
VI. Using a historical population matched for potential confounding clinicopathologic variables, evaluate differences in rate of unplanned re-operation.
OUTLINE:
Patients receive botulinum toxin type A via endoscopic injection into intraduodenal sphincter of Oddi segment between 7-14 days prior to planned distal pancreas resection.
Patients are followed for 30 days following distal pancreas resection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment of POPF (botulinum toxin type A) | Experimental | Patients receive botulinum toxin type A via endoscopic injection into intraduodenal sphincter of Oddi segment between 7-14 days prior to planned distal pancreas resection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Botulinum Toxin Type A | Biological | Given via endoscopic injection into intraduodenal sphincter of Oddi segment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Clinically Relevant Postoperative Pancreatic Fistula (POPF) | Defined by standard biochemical definitions of POPF per the International Study Group of Pancreatic Fistula (ISGPF) criteria. | Up to postoperative day 30 |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Serious Adverse Event | Using the safety analysis set, the rate of serious adverse events following endoscopic BTX injection into the sphincter of Oddi as a single agent will be determined for participants undergoing distal pancreas resections. The 95% confidence interval will be reported with the point estimate of serious adverse events (SAE) rate. | Prior to surgery up to 30 days post surgery (up to 3 months) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brett C Sheppard, M.D., FACS | OHSU Knight Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OHSU Knight Cancer Institute | Portland | Oregon | 97239 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment of POPF (Botulinum Toxin Type A) | Patients receive botulinum toxin type A via endoscopic injection into intraduodenal sphincter of Oddi segment between 7-14 days prior to planned distal pancreas resection. Botulinum Toxin Type A: Given via endoscopic injection into intraduodenal sphincter of Oddi segment |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment of POPF (Botulinum Toxin Type A) | Patients receive botulinum toxin type A via endoscopic injection into intraduodenal sphincter of Oddi segment between 7-14 days prior to planned distal pancreas resection. Botulinum Toxin Type A: Given via endoscopic injection into intraduodenal sphincter of Oddi segment |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 Clinically Relevant Postoperative Pancreatic Fistula (POPF) | Defined by standard biochemical definitions of POPF per the International Study Group of Pancreatic Fistula (ISGPF) criteria. | Posted | Count of Participants | Participants | Up to postoperative day 30 |
|
|
Prior to surgery up to 30 days post 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 | Treatment of POPF (Botulinum Toxin Type A) | Patients receive botulinum toxin type A via endoscopic injection into intraduodenal sphincter of Oddi segment between 7-14 days prior to planned distal pancreas resection. Botulinum Toxin Type A: Given via endoscopic injection into intraduodenal sphincter of Oddi segment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Inpatient Hospitalization | Renal and urinary disorders | Non-systematic Assessment | Patient was re-admitted to the hospital on 4/5/2023 after follow-up clinic labs demonstrated acute AKI. SAE assessed as unrelated to study participation but rather a surgical technical error. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Brett Sheppard | OHSU Knight Cancer Institute | 503-494-9169 | sheppard@ohsu.edu |
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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 | Oct 2, 2023 | Jan 23, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| C542869 | abobotulinumtoxinA |
| C545476 | incobotulinumtoxinA |
| C000630868 | prabotulinumtoxin A |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
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| Number of Participants With Any POPF | Prior to surgery up to 30 days post surgery (up to 3 months) |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| 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 |
|
| Participants |
|
|
| Secondary | Rate of Serious Adverse Event | Using the safety analysis set, the rate of serious adverse events following endoscopic BTX injection into the sphincter of Oddi as a single agent will be determined for participants undergoing distal pancreas resections. The 95% confidence interval will be reported with the point estimate of serious adverse events (SAE) rate. | Posted | Count of Participants | Participants | Prior to surgery up to 30 days post surgery (up to 3 months) |
|
|
|
| Secondary | Number of Participants With Any POPF | Posted | Count of Participants | Participants | Prior to surgery up to 30 days post surgery (up to 3 months) |
|
|
|
| 0 |
| 4 |
| 1 |
| 4 |
| 0 |
| 4 |
|
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| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D006867 |
| Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |