The Effect of ERAS on Pancreaticoduodenectomy (v2.0)

August 22, 2023 updated by: Dae Wook Hwang, Asan Medical Center

The Effect of Enhanced Recovery After Surgery (ERAS) on Pancreaticoduodenectomy in Patients With Hepatobiliary-Pancreas (HBP) Disease

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This study was a single-institution, randomized controlled clinical trial to test the superiority of Enhanced Recovery After Surgery (ERAS) protocol for patients with pancreaticoduodenectomy (PD).

This study will be conducted on adult patients who are planning to undergo pancreaticoduodenectomy for the treatment of periampullary disease for 12 months after the start of the study.

Based on the results of the previous study which choose the functional recovery date as a primary outcome (control group; 9.0 ± 4.3 days, intervention group; 7.6 ± 4.3 days), a total of 334 patients (167 patients in each group) will be enrolled when calculated with power 0.8, α = 0.05, a two-tailed test, and a 10% withdrawal rate.

Investigators plan to randomize patients covered by the existing ERAS program to the control group and patients covered by the full ERAS protocol to the experimental group.

Investigators plan to observe the clinical outcomes up to 3 months after surgery.

The primary outcome is the functional recovery date, and secondary outcomes are the postoperative complication rate, postoperative mortality, and readmission rate.

All subjects who were randomized and received any study intervention were obliged to follow the study protocol and monitored for best compliance, per-protocol set or safety set was not defined differently.

Study Type

Interventional

Enrollment (Estimated)

334

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 05505
        • Division of Hepatobiliary and Pancreatic Surgery, Department of Surgery, Asan Medical Center, University of Ulsan College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Patients with coagulopathy (Platelet < 125,000/mm3 or International Normalized Ratio (INR) ≥ 1.5) or who continue to take anticoagulants or antithrombotic drugs without stopping
  • Others who are not suitable for research in the judgment of the clinician

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Conventional
Conventional ERAS program
Experimental: Experimental
complete ERAS program (Conventional ERAS program + Epidural analgesia + Fluid balance)
Other: ERAS perioperative management
  • Epidural analgesia
  • Fluid balance
  • Other items are the same as conventional
Other Names:
  • Fast tract

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional recovery date on postopreative 7th day
Time Frame: 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.
  • 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative complication
Time Frame: Three months after surgery

All complications after surgery are included. Especially, delayed gastric emptying, postpancreatectomy hemorrhage, postoperative pancreatic fistula and chyle leak will be classified by the criteria of International Study Group on Pancreatic Surgery.

The severity of all complication will be divided depends on Clavien Dindo classification (Grade from I to V, higher scores mean a better outcome).
Three months after surgery
Postoperative mortality
Time Frame: 90 days after surgery
All in-hospital mortality and 90 days mortality
90 days after surgery
Re-admission rate
Time Frame: 3 months after surgery
For any reason, all readmitted patients are included.
3 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asan Medical Center

Investigators

  • Principal Investigator: Dae Wook Hwang, M.D., PhD, Asan Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2023

Primary Completion (Estimated)

June 30, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

November 16, 2022

First Submitted That Met QC Criteria

August 22, 2023

First Posted (Actual)

August 24, 2023

Study Record Updates

Last Update Posted (Actual)

August 24, 2023

Last Update Submitted That Met QC Criteria

August 22, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-1204

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

It can be determined in accordance with the Personal Information Protection Act of KOREA and institutional data sharing regulations.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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