Endoscopic Botulinum Toxin Injection in the Prevention of Postoperative Pancreatic Fistula Following Distal Pancreatectomy
Model scores of the 29,894 trials active now.
Model score 24% for any early termination, 12% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 26% of the time (3,728 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Terminated on 2024-07-10, after 2023-03-01 start.
Reason given by the sponsor: “enrollment”
The score above never used this outcome: finished trial that started in 2015 or later: the model never saw it during training.
Termination over time, as the model saw it at the start
Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2024-07-10. The rest of the way to 100% is still running.
From the competing-risks survival model (termination vs completion, still-running trials censored), fit to trials that started 2008–2014 and recalibrated to termination rates over 2022–2024, since termination has become more common. Checked on past years, it still ran a little low when the rise continued.
What moved the score
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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: iiheartliverpancreaticsurgery
Phrases that lowered it: participantparticipantsadministrationformulation14 days -
Sponsor's past termination rate: 38.3% (raises risk) · Sponsor's track record
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Accepts healthy volunteers: No (raises risk) · Who can join
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Phase: 2 (raises risk) · Design
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Has a data monitoring committee: not given (lowers risk) · Design
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Disease area, cancer: Yes (raises risk) · Disease area
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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Drug's FAERS reports marked serious: 18.0% (lowers risk) · Drug's FDA history
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Design: single group (raises risk) · Design
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Minimum age: 18 (raises risk) · Who can join
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Primary purpose: treatment (raises risk) · Design
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Responsible party: principal investigator (lowers risk) · Design
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Number of arms: 1 (raises risk) · Design
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Trials the sponsor started in the prior 2 years: 16 (lowers risk) · Sponsor's track record
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Maximum age: not given (raises risk) · Who can join
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Drugs with FDA adverse-event history: 4 (lowers risk) · Drug's FDA history
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Collaborators: 1 (raises risk) · Design
Every input that moved this score, largest first: SHAP contributions in log-odds, red raising risk and green lowering it. They describe the model, not causes of termination. Phrases are traced from the text features back to this registration's words, approximately.
The trial
Design
- Phase
- 2
- Number of arms
- 1 (typical: 2)
- Allocation
- not applicable (typical: randomized)
- Design
- single group (typical: parallel)
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- not given (typical: 56% yes)
- Responsible party
- principal investigator (typical: sponsor)
- Collaborators
- 1 (typical: 0)
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- not given (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 107 (typical: 32)
- Sponsor's past termination rate
- 38.3% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 16 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 4 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 71849 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 6459 (typical: 412.5)
- Drug's FAERS reports marked serious
- 18.0% (typical: 85.6%)
- Drug's FAERS reports with a death
- 1.7% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer, digestive, endocrine
- Drugs matched to FDA substances
- abobotulinumtoxina, botulinum toxin type a, incobotulinumtoxina, onabotulinumtoxina
Typical values are among the trials active now. Sponsor and drug history are counted only up to this trial's start date.
Similar finished trials
- Secretin Infusion to Prevent Pancreatic Leaks Following Pancreatic Resection NCT02160808 · started 2014 · scored riskier than 96% of active trials completed
- Prevention of Postoperative Pancreatic Fistula by Somatostatin NCT03000946 · started 2017 · scored riskier than 68% of active trials completed
- Study of Pancreatic Enzyme Replacement on Completion of Adjuvant Chemotherapy for Resected Pancreatic Adenocarcinoma NCT03469258 · started 2018 · scored riskier than 98% of active trials terminated
- Botulinum Toxin Type A in Preventing Complications After Surgery in Patients With Esophageal Cancer NCT02965976 · started 2016 · scored riskier than 89% of active trials completed
- Pancreatic Enzyme Supplementation in Patients With Unresectable Pancreatic Cancer (PESUP) NCT01587534 · started 2011 · scored riskier than 94% of active trials completed
Closest by meaning of the registration text (PubMedBERT embeddings), among finished trials. How they ended is context, not an input to this trial's score.