NCT06009224

Brief Summary

Enhanced Recovery After Surgery (ERAS) is not a program that aims to reduce postoperative hospital stay, but the multimodal strategies that aim to attenuate the loss of, and improve the restoration of, functional capacity after surgery on evidence-based medicine. The benefits of ERAS are proven in many surgical procedures, such as upper gastrointestinal surgery and colorectal surgery. Investigators performed Randomized Controlled Trials to evaluate the non-inferiority of modified ERAS protocol for pancreaticoduodenectomy (PD) by introducing standardized pre- and post-operative treatment based on ERAS treatment guidelines (ERAS on PD, Research Institute Clinical Progress, 2014-0961; ClinicalTrials.gov, NCT02372331). As a result of the study, the ERAS protocol proved to be non-inferior to the existing pre- and post-operative treatment in terms of surgical complications, mortality, hospital stay, total hospital cost, and most nutritional indicators. However, the previous study did not include a few important intraoperative items such as epidural analgesia and fluid balance among the main items of the ERAS protocol. This trial aims to evaluate the clinical results by applying the complete ERAS protocol.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
334

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 16, 2022

Completed
9 months until next milestone

First Posted

Study publicly available on registry

August 24, 2023

Completed
8 days until next milestone

Study Start

First participant enrolled

September 1, 2023

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

August 24, 2023

Status Verified

August 1, 2023

Enrollment Period

1.8 years

First QC Date

November 16, 2022

Last Update Submit

August 22, 2023

Conditions

Periampullary CancerBorderline Malignancy Tumor

Keywords

Enhanced Recovery After SurgeryPancreaticoduodenectomyPeriampullary cancerFast track surgeryPostoperative complication

Outcome Measures

Primary Outcomes (1)

  • Functional recovery date on postopreative 7th day

    * Pain control is possible only with oral or patch-type analgesics without intravenous analgesic administration * Able to walk freely * Free eating is possible * There should be no evidence of infection related to surgery * No intravenous nutritional injection (total parenteral nutrition) being administered

    The investigators evaluate the five items to the participant starting on the 7th day after surgery. A date that satisfies all five items is defined as functional recovery date.

Secondary Outcomes (3)

  • Postoperative complication

    Three months after surgery

  • Postoperative mortality

    90 days after surgery

  • Re-admission rate

    3 months after surgery

Study Arms (2)

Conventional

NO INTERVENTION

Conventional ERAS program

Experimental

EXPERIMENTAL

complete ERAS program (Conventional ERAS program + Epidural analgesia + Fluid balance)

Other: ERAS perioperative management

Interventions

ERAS perioperative managementOTHER

* Epidural analgesia * Fluid balance * Other items are the same as conventional

Also known as: Fast tract
Experimental

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age: 18 to 80 years old
  • Performance: Eastern Cooperative Oncology Group (ECOG) 0-2
  • Resectable or borderline resectable malignant tumor or borderline malignant tumor on the periampullary area
  • No distant metastases
  • Bone marrow function: White Blood Cell (WBC) at least 3,000/mm3 or Absolute Neutrophil Count (ANC) ≥ 1,500/mm3, Platelet count at least 125,000/mm3
  • Liver function: aspartate aminotransferase (AST) / alanine aminotransferase (ALT) less than 3 times the upper limit of normal
  • Renal function: Creatinine no greater than 1.5 times the upper limit of normal
  • Patients who consented and signed informed consent

You may not qualify if:

  • Patients with distant metastases or patients with recurrent periampullary carcinoma
  • Patients with active or uncontrolled infection
  • Patients with severe psychiatric/neurological disorders
  • People who are addicted to alcohol or other drugs
  • Patients included in other clinical studies that may affect this study
  • Patients unable to follow the researcher's instructions
  • Pregnancy
  • Patients with uncontrolled heart disease
  • Patients with moderate or more comorbidities that are judged to have an impact on quality of life or nutritional status (liver cirrhosis, chronic renal failure, heart failure, etc.)
  • Patients who underwent major abdominal organ surgery other than scheduled pancreaticoduodenectomy.
  • Patients who require combined resection of other major abdominal organs in addition to scheduled pancreaticoduodenectomy
  • History of allergy to local anesthetics
  • Local infection at the treatment site
  • Patients with neurological or mental health conditions
  • A history of spinal surgery or compression fractures at abdominal level
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Hepatobiliary and Pancreatic Surgery, Department of Surgery, Asan Medical Center, University of Ulsan College of Medicine

Seoul, 05505, South Korea

Location

Related Publications (6)

  • Hwang DW, Kim HJ, Lee JH, Song KB, Kim MH, Lee SK, Choi KT, Jun IG, Bang JY, Kim SC. Effect of Enhanced Recovery After Surgery program on pancreaticoduodenectomy: a randomized controlled trial. J Hepatobiliary Pancreat Sci. 2019 Aug;26(8):360-369. doi: 10.1002/jhbp.641. Epub 2019 Jul 2.

    PMID: 31152686RESULT

  • Melloul E, Lassen K, Roulin D, Grass F, Perinel J, Adham M, Wellge EB, Kunzler F, Besselink MG, Asbun H, Scott MJ, Dejong CHC, Vrochides D, Aloia T, Izbicki JR, Demartines N. Guidelines for Perioperative Care for Pancreatoduodenectomy: Enhanced Recovery After Surgery (ERAS) Recommendations 2019. World J Surg. 2020 Jul;44(7):2056-2084. doi: 10.1007/s00268-020-05462-w.

    PMID: 32161987RESULT

  • Feldheiser A, Aziz O, Baldini G, Cox BP, Fearon KC, Feldman LS, Gan TJ, Kennedy RH, Ljungqvist O, Lobo DN, Miller T, Radtke FF, Ruiz Garces T, Schricker T, Scott MJ, Thacker JK, Ytrebo LM, Carli F. Enhanced Recovery After Surgery (ERAS) for gastrointestinal surgery, part 2: consensus statement for anaesthesia practice. Acta Anaesthesiol Scand. 2016 Mar;60(3):289-334. doi: 10.1111/aas.12651. Epub 2015 Oct 30.

    PMID: 26514824RESULT

  • Kuemmerli C, Tschuor C, Kasai M, Alseidi AA, Balzano G, Bouwense S, Braga M, Coolsen M, Daniel SK, Dervenis C, Falconi M, Hwang DW, Kagedan DJ, Kim SC, Lavu H, Liang T, Nussbaum D, Partelli S, Passeri MJ, Pecorelli N, Pillai SA, Pillarisetty VG, Pucci MJ, Su W, Sutcliffe RP, Tingstedt B, van der Kolk M, Vrochides D, Wei A, Williamsson C, Yeo CJ, Zani S, Zouros E, Abu Hilal M. Impact of enhanced recovery protocols after pancreatoduodenectomy: meta-analysis. Br J Surg. 2022 Feb 24;109(3):256-266. doi: 10.1093/bjs/znab436.

    PMID: 35037019RESULT

  • Lee JH, Kim DH, Koh WU. Real-time ultrasound guided thoracic epidural catheterization: a technical review. Anesth Pain Med (Seoul). 2021 Oct;16(4):322-328. doi: 10.17085/apm.21060. Epub 2021 Oct 29.

    PMID: 34289297RESULT

  • Kim HE, Kim YH, Song KB, Chung YS, Hwang S, Lee YJ, Park KM, Kim SC. Impact of critical pathway implementation on hospital stay and costs in patients undergoing pancreaticoduodenectomy. Korean J Hepatobiliary Pancreat Surg. 2014 Feb;18(1):14-20. doi: 10.14701/kjhbps.2014.18.1.14. Epub 2014 Feb 24.

    PMID: 26155241RESULT

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Dae Wook Hwang, M.D., PhD

    Asan Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dae Wook Hwang, M.D., PhD

CONTACT

82230103939drdwhwang@gmail.com

Min Kyu Sung, M.D.

CONTACT

82230100541skystar8608@naver.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The evaluation and judgment for morbidity (primary endpoint) / mortality (secondary endpoint) was made by Morbidity and Mortality Committee in our division. Committee members were blinded about knowledge of the interventions assigned to individual participants.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Two study groups (Control (conventional) group and study (intervention) group) were randomly allocated and assigned to one of two groups in parallel for the whole duration of this study.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

November 16, 2022

First Posted

August 24, 2023

Study Start

September 1, 2023

Primary Completion

June 30, 2025

Study Completion

December 31, 2025

Last Updated

August 24, 2023

Record last verified: 2023-08

Locations

KR(1)