NCT07017361Not yet recruitingNot Applicable
A Multicenter Randomized Prospective Study on Establishing an ERAS Program and Optimized Clinical Protocol for Patients Undergoing Minimally Invasive Pancreatoduodenectomy (MIPD)
Seoul National University Hospital1 site in 1 country140 target enrollmentStarted: July 15, 2025Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 140
- Locations
- 1
- Primary Endpoint
- Proportion of Participants Meeting Discharge Criteria by Post-operative Day 5 Afternoon
Study Overview
Brief Summary
To evaluate the impact of an Enhanced Recovery After Surgery (ERAS) program on postoperative recovery in patients undergoing minimally invasive pancreatoduodenectomy (MIPD)
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 19 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age ≥ 19 years, scheduled for standard minimally invasive (robotic or laparoscopic) pancreatoduodenectomy for periampullary tumors
- •ECOG performance status of 0 or 1 at screening
- •Able to provide written informed consent, understand study procedures, and complete patient-reported questionnaires
- •ASA physical status classification I-III
Exclusion Criteria
- •Hypersensitivity to fentanyl or ropivacaine
- •Cognitive impairment preventing independent use of patient-controlled analgesia or completion of questionnaires
- •Major internal medical or psychiatric disorders affecting treatment response
- •Severe hepatic or renal dysfunction
- •Any condition deemed inappropriate for study participation by the investigator
Arms & Interventions
ERAS
Experimental
Intervention: ERAS (Procedure)
Conventional
Active Comparator
Intervention: Conventional (Procedure)
Outcomes
Primary Outcomes
Proportion of Participants Meeting Discharge Criteria by Post-operative Day 5 Afternoon
Time Frame: Up to the afternoon of Post-operative Day 5
Secondary Outcomes
- Length of Post-operative Hospital Stay (Days)(Post-operative Day 0 until hospital discharge (assessed up to Post-operative Day 30))
- Incidence of Major Complications (Clavien-Dindo ≥ Grade IIIa) Within 30 Days(Post-operative Day 0 to Day 30)
- Total Direct Medical Costs per Participant (KRW) During Index Hospitalization(Post-operative Day 0 until hospital discharge (assessed up to Post-operative Day 30))
Investigators
Wooil Kwon
Associate Professor
Seoul National University Hospital
Study Sites (1)
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