Pancreatic CarcinomaPhase 2NCT04965311
Endoscopic Botulinum Toxin Injection in the Prevention of Postoperative Pancreatic Fistula Following Distal Pancreatectomy
A Phase 2 study testing Botulinum Toxin Type A in people with Pancreatic Carcinoma, run by OHSU Knight Cancer Institute at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Carcinoma
- What is being tested?
- Botulinum Toxin Type A
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2023to 10 Jul 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant scheduled for elective distal pancreatectomy or radical antegrade modular pancreatosplenectomy (RAMPS), via open or laparoscopic technique
- Participant >= 18 years of age
- Ability to understand nature and individual consequences of clinical trial
- Written informed consent from participant or legally authorized representative
- For participants of childbearing potential, a negative pregnancy test and adequate contraception until 14 days after trial intervention
Who cannot join
- Known hypersensitivity to any BTX preparation or to any of the components in the formulation
- Infection at the proposed injection site, including cholangitis
- Anatomy incompatible with planned intervention (e.g., Roux-en-Y gastric bypass, distal gastrectomy with Roux-en-Y or Billroth II reconstruction)
- Acute pancreatitis within 2 weeks of planned study intervention
- American Society of Anesthesiologists (ASA) score > III
- Serious cardiovascular disease (e.g., myocardial infarction in the past year, New York Heart Association [NYHA] III/IV congestive heart failure, unstable angina)
Show all 14Show fewer
- Creatinine clearance < 30 mL/min
- Liver cirrhosis (of any Child-Pugh grade)
- Neuromuscular or any neurological disease with associated increased risk for a participant undergoing BTX injection
- Prior BTX administration
- Inability to obtain informed consent due to comprehension or language barrier
- Inability to comply with study and/or follow-up procedures
- Pregnancy or lactation
- Any condition that could result in undue risk for the participant and/or influence outcome measures (in the opinion of the investigator)
Trial locations and contacts
1 site in 1 country.
United States1 site
OHSU Knight Cancer Institute
Portland, Oregon, 97239
About this study
Official title: A Phase II Trial of Pre-Operative Endoscopic Botulinum Toxin Injection in the Prevention of Postoperative Pancreatic Fistula Following Distal Pancreatectomy
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.
Read the detailed description
PRIMARY OBJECTIVE:
- 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:
- 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:
- 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.
- 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.
- Conditions
- Pancreatic Carcinoma
- Being tested
- Botulinum Toxin Type A
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum Toxin Type ABiological
Also called AbobotulinumtoxinA, Botox, Botox Cosmetic, Botulinum A Toxin
Given via endoscopic injection into intraduodenal sphincter of Oddi segment
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: Botulinum Toxin Type A |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to postoperative day 30
Secondary outcomes (2)
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.
Measured: Prior to surgery up to 30 days post surgery (up to 3 months)
Number of Participants With Any POPF
Measured: Prior to surgery up to 30 days post surgery (up to 3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2021
- Study start1 Mar 2023
- Primary completion10 Jul 2024
- Study completion10 Jul 2024
Why it stopped: low enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pancreatic CarcinomaStudies of the same condition, open and under way.
- More trials run by OHSU Knight Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- OHSU Knight Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Oregon Health and Science University
- Responsible party
- Principal investigator, Brett C. Sheppard, M.D., FACS, OHSU Knight Cancer Institute
- Investigators
- Brett C Sheppard, M.D., FACS, Principal investigator, OHSU Knight Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04965311
- Sponsor's protocol ID
- STUDY00022619
- Other IDs
- NCI-2021-06239, STUDY00022619
- Status last verified
- May 2025
- First submitted
- 7 Jul 2021
- Last updated
- 13 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Pre-Operative Endoscopic Botulinum Toxin Injection in the Prevention of Postoperative Pancreatic Fistula Following Distal Pancreatectomy
- ClinicalTrials.gov ID
- NCT04965311
- Acronym / sponsor ID
- STUDY00022619
- Conditions
- Pancreatic Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: low enrollment
- Enrolment
- 4 participants (actual)
- Lead sponsor
- OHSU Knight Cancer InstituteUniversity, hospital or other
- Collaborators
- Oregon Health and Science University
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 10 Jul 2024 (actual)
- Study completion
- 10 Jul 2024 (actual)
- First posted
- 16 Jul 2021 (actual)
- Results
- Posted 13 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVE:
- 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:
- 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:
- 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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment of POPF (botulinum toxin type A) | Experimental | Biological: Botulinum Toxin Type APatients receive botulinum toxin type A via endoscopic injection into intraduodenal sphincter of Oddi segment between 7-14 days prior to planned distal pancreas resection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participant scheduled for elective distal pancreatectomy or radical antegrade modular pancreatosplenectomy (RAMPS), via open or laparoscopic technique
- Participant >= 18 years of age
- Ability to understand nature and individual consequences of clinical trial
- Written informed consent from participant or legally authorized representative
- For participants of childbearing potential, a negative pregnancy test and adequate contraception until 14 days after trial intervention
Key exclusion criteria (14 listed)
- Known hypersensitivity to any BTX preparation or to any of the components in the formulation
- Infection at the proposed injection site, including cholangitis
- Anatomy incompatible with planned intervention (e.g., Roux-en-Y gastric bypass, distal gastrectomy with Roux-en-Y or Billroth II reconstruction)
- Acute pancreatitis within 2 weeks of planned study intervention
- American Society of Anesthesiologists (ASA) score > III
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Botulinum Toxin Type AAlso: AbobotulinumtoxinA, Botox, Botox Cosmetic, Botulinum A ToxinGiven via endoscopic injection into intraduodenal sphincter of Oddi segment | Biological | Treatment of POPF (botulinum toxin type A) |
Primary outcome
Number of Participants With Clinically Relevant Postoperative Pancreatic Fistula (POPF)
Time frame: Up to postoperative day 30
Defined by standard biochemical definitions of POPF per the International Study Group of Pancreatic Fistula (ISGPF) criteria.
2 secondary outcomes
Rate of Serious Adverse Event
Time frame: Prior to surgery up to 30 days post surgery (up to 3 months)
Number of Participants With Any POPF
Time frame: Prior to surgery up to 30 days post surgery (up to 3 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brett C Sheppard, M.D., FACS principal investigator
OHSU Knight Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Botulinum Toxin Type A in people with Pancreatic Carcinoma, run by OHSU Knight Cancer Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Clinically Relevant Postoperative Pancreatic Fistula (POPF) (time frame: Up to postoperative day 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2025.