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ERAS Program Implementation for MIPD

Effectiveness of evidence-based standardized clinical pathway on postoperative recovery after minimally-invasive pancreaticoduodenectomy: A-multi-center, open-labeled randomized controlled study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0010621
Enrollment
140
Registered
2025-06-11
Start date
2025-07-14
Completion date
Unknown
Last updated
2025-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Others(Postoperative management) : Intervention Group 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. Control Group Pre-operative fasting: NPO for solids and fluids from 00:00
no preemptive oral analgesia. Intra-operative management: IV dexamethasone 5 mg at anesthesia induction
IV acetaminophen 1 g administered 1 h before wound closure. Post-operative nutrition: Levin tube removed in the OR
POD 1 morning—sips of water
POD 3 morning—upright abdominal X-ray
if normal, start soft fluid diet on POD 3 evening
POD 4—pancreatobiliary CT
if normal, start soft bland diet at lunch. Drain management: Two drains placed at the hepaticojejunostomy and pancreaticojejunostomy sites
drain fluid amylase measured on POD 1, POD 3, and POD 5
if POD 4 CT is normal, remove drains on POD 5 per surgeon’s discretion (based on drain output, fever, pain). Analgesia: IV-PCA maintained until approximately POD 3
from POD 3 morning onward, oral acetaminophen 650 mg every 8 h.

Sponsors

Seoul National University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: A. Age = 19 years, scheduled for standard minimally invasive (robotic or laparoscopic) pancreatoduodenectomy for periampullary tumors B. ECOG performance status of 0 or 1 at screening C. Able to provide written informed consent, understand study procedures, and complete patient-reported questionnaires D. ASA physical status classification I-III

Exclusion criteria

Exclusion criteria: A. Hypersensitivity to fentanyl or ropivacaine B. Cognitive impairment preventing independent use of patient-controlled analgesia or completion of questionnaires C. Major internal medical or psychiatric disorders affecting treatment response D. Severe hepatic or renal dysfunction E. Any condition deemed inappropriate for study participation by the investigator

Design outcomes

Primary

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

Secondary

MeasureTime frame
Length of Post-operative Hospital Stay (Days);Poatoperative nausea/vomiting rate;Incidence of postoperative POPF;Postoperative pain score;Total opioid use;Comprehensive comorbidity index

Countries

Korea, Republic of

Contacts

Public ContactYoung Jae Cho

Seoul National University Hospital

whdudwo85@naver.com+82-2-2072-2817

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026