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NCT Number: NCT07017361

ERAS Program Implementation for MIPD

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

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Conventional

Procedure

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 pancreaticojejunostomy; drain amylase measured POD1, 3 and 5; if POD4 CT normal, drains removable from POD5 per surgeon discretion (output, fever, pain). Analgesia: IV PCA until ≈POD3, then oral acetaminophen 650 mg every 8 h. No carbohydrate loading or NSAID/nefopam adjuncts.

ERAS

Procedure

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. Drain mgmt: same placement; amylase POD1 & 3; if POD4 CT normal and amylase ≤ 5 000 U/L trending down, remove drains POD4; otherwise per surgeon. Analgesia: IV PCA until ≈POD3; until POD1 morning, IV acetaminophen 1 g + ibuprofen 300 mg q8h; POD1-5, oral acetaminophen 650 mg + zaltoprofen 80 mg q8h.

Primary outcomes

  1. 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

  1. Length of Post-operative Hospital Stay (Days)

    Time frame: Post-operative Day 0 until hospital discharge (assessed up to Post-operative Day 30)

  2. Incidence of Major Complications (Clavien-Dindo ≥ Grade IIIa) Within 30 Days

    Time frame: Post-operative Day 0 to Day 30

  3. 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Young Jae Cho, M.D.

CONTACT

[email protected]

+821023783631

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • Korea University Anam Hospital
  • SMG-SNU Boramae Medical Center

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jun 12, 2025
Registry last updated
Jun 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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