Clinical trial · Interventional
Whipple Procedure: Standard of Care vs. Thunderbeat
Thunderbeat™ Integrated Bipolar and Ultrasonic Forceps in the Whipple Procedure: A Prospective Registry Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Principal Investigator and Study Sponsor decided to terminate the study early
Summary
Brief summary (as posted)
The Whipple procedure is the standard method for therapy for cancerous tumors, inflammation, and stenosis (narrowing) near the head of the pancreas. This is a prospective study to assess whether or not use of the Thunderbeat™ device may decrease blood loss and postoperative morbidity (the presence of illness or disease). The findings will then be compared to patients whose Whipple procedure will be performed using conventional dissection and hemostasis techniques.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bile Duct Carcinoma | Cholangiocarcinoma | ALIAS | 0.90 |
| Pancreatic Neoplasms | Pancreatic Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Standard of care scissors, ligatures, clips, and sutures | Device | — | UNRESOLVED |
| Thunderbeat | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Control Group
- description
- In the control group, scissors, ligatures, clips and sutures will be used for dissection and hemostasis as necessary.
- interventionNames
- Device: Standard of care scissors, ligatures, clips, and sutures
- type
- EXPERIMENTAL
- label
- Thunderbeat™
- description
- -In the Thunderbeat™ group, dissection and hemostasis of vessels will be performed using the Thunderbeat™ device (Olympus, Japan).
- interventionNames
- Device: Thunderbeat
Primary outcomes (2)
- measure
- Operative Blood Loss
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 22 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Scheduled to undergo an elective open or laparoscopic Whipple procedure * At least 22 years of age. * Karnofsky performance status greater than or equal to 80%. * Able to understand and willing to sign a written informed consent document. Exclusion Criteria: * Pregnant or breastfeeding. * Surgeon's opinion at the time of dissection that the subject's well being (e.g. bleeding or other independent acute health problems) would be compromised.
References
Publications (0)
Data not yet available