ERAS Program Implementation for MIPD

NCT07017361 | Not Yet Recruiting

• 1 other identifier: H-2502-154-1619
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pancreaticoduodenectomy; ERAS; Minimally Invasive Surgery

Keywords

Pancreaticoduodenectomy; ERAS; Minimally Invasive Surgery

Outcome Measures

Primary Outcomes (1)

• Proportion of Participants Meeting Discharge Criteria by Post-operative Day 5 Afternoon

  Up to the afternoon of Post-operative Day 5

Secondary Outcomes (3)

• 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)

Study Arms (2)

Conventional

ACTIVE COMPARATOR

Procedure: Conventional

ERAS

EXPERIMENTAL

Procedure: ERAS

Interventions

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.

Conventional

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.

ERAS

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead
• SMG-SNU Boramae Medical Center: collaborator
• Korea University Anam Hospital: collaborator

Study Sites (1)

Seoul National University Hospital

Daehak-ro, Jongno-gu, Seoul, 03080, South Korea

Location

MeSH Terms

Interventions

Congresses as Topic

Intervention Hierarchy (Ancestors)

Organizations; Health Care Economics and Organizations

Central Study Contacts

Young Jae Cho, M.D.

CONTACT

+821023783631; whdudwo85@naver.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 20, 2025
• First Posted: June 12, 2025
• Study Start: July 15, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: June 17, 2025

Record last verified: 2025-06

Locations

KR (1)