Trial Outcomes & Findings for Endoscopic Botulinum Toxin Injection in the Prevention of Postoperative Pancreatic Fistula Following Distal Pancreatectomy (NCT NCT04965311)
NCT ID: NCT04965311
Last Updated: 2025-05-13
Results Overview
Defined by standard biochemical definitions of POPF per the International Study Group of Pancreatic Fistula (ISGPF) criteria.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
4 participants
Primary outcome timeframe
Up to postoperative day 30
Results posted on
2025-05-13
Participant Flow
Participant milestones
| Measure |
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
|
|---|---|
|
Overall Study
STARTED
|
4
|
|
Overall Study
COMPLETED
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Endoscopic Botulinum Toxin Injection in the Prevention of Postoperative Pancreatic Fistula Following Distal Pancreatectomy
Baseline characteristics by cohort
| Measure |
Treatment of POPF (Botulinum Toxin Type A)
n=4 Participants
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
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=99 Participants
|
|
Age, Continuous
|
58.75 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Up to postoperative day 30Defined by standard biochemical definitions of POPF per the International Study Group of Pancreatic Fistula (ISGPF) criteria.
Outcome measures
| Measure |
Treatment of POPF (Botulinum Toxin Type A)
n=4 Participants
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
|
|---|---|
|
Number of Participants With Clinically Relevant Postoperative Pancreatic Fistula (POPF)
|
0 Participants
|
SECONDARY outcome
Timeframe: Prior to surgery up to 30 days post surgery (up to 3 months)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.
Outcome measures
| Measure |
Treatment of POPF (Botulinum Toxin Type A)
n=4 Participants
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
|
|---|---|
|
Rate of Serious Adverse Event
|
1 Participants
|
SECONDARY outcome
Timeframe: Prior to surgery up to 30 days post surgery (up to 3 months)Outcome measures
| Measure |
Treatment of POPF (Botulinum Toxin Type A)
n=4 Participants
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
|
|---|---|
|
Number of Participants With Any POPF
|
0 Participants
|
Adverse Events
Treatment of POPF (Botulinum Toxin Type A)
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment of POPF (Botulinum Toxin Type A)
n=4 participants at risk
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
|
|---|---|
|
Renal and urinary disorders
Inpatient Hospitalization
|
25.0%
1/4 • Number of events 1 • Prior to surgery up to 30 days post surgery
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place