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Not yet recruiting NCT07017361

ERAS Program Implementation for MIPD

No phase Interventional Pancreaticoduodenectomy ERAS Minimally Invasive Surgery

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Conventional, ERAS.
Who it may be relevant to
Registry conditions: Pancreaticoduodenectomy, ERAS, Minimally Invasive Surgery. Basic parameters: from 19 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

A Multicenter Randomized Prospective Study on Establishing an ERAS Program and Optimized Clinical Protocol for Patients Undergoing Minimally Invasive Pancreatoduodenectomy (MIPD)

Overview

To evaluate the impact of an Enhanced Recovery After Surgery (ERAS) program on postoperative recovery in patients undergoing minimally invasive pancreatoduodenectomy (MIPD)

Interventions

  • Procedure Conventional
    Pre-operative fasting: NPO for solids and fluids from 00:00. No pre-emptive oral analgesia. Intra-operative: IV dexamethasone 5 mg at anaesthesia induction; IV acetaminophen 1 g about 1 h before wound closure. Post-operative nutrition: Levin tube removed in OR. POD1 morning-sips of water; POD3 morning upright abdominal X-ray; if normal, start soft fluid diet POD3 evening. POD4 pancreatobiliary CT; if normal, start soft bland diet at lunch. Drain management: two drains at hepaticojejunostomy and
  • Procedure ERAS
    Pre-op fasting: solids NPO from 00:00; clear fluids until 3 h pre-op; 300 mL carbohydrate drink 2-4 h pre-op with oral acetaminophen 650 mg + zaltoprofen 80 mg. Intra-op: IV dexamethasone 8 mg at induction; IV acetaminophen 1 g + ibuprofen 300 mg + nefopam 20 mg 1 h before closure. Post-op nutrition: Levin tube removed in OR. POD1 sips of water; POD2 morning upright abdominal X-ray-if normal, start soft fluid diet POD2 evening. POD3 pancreatobiliary CT-if normal, start soft bland diet at lunch.

Primary outcome measures

  • Proportion of Participants Meeting Discharge Criteria by Post-operative Day 5 Afternoon [Time frame: Up to the afternoon of Post-operative Day 5]
Secondary outcome measures (3)
  • Length of Post-operative Hospital Stay (Days) [Time frame: 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 [Time frame: Post-operative Day 0 to Day 30]
  • Total Direct Medical Costs per Participant (KRW) During Index Hospitalization [Time frame: Post-operative Day 0 until hospital discharge (assessed up to Post-operative Day 30)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

South Korea · 1 center
  • Seoul National University Hospital — Daehak-ro, Jongno-gu

Identifiers

NCT: NCT07017361 · H-2502-154-1619

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗