The Effect of ERAS on Pancreaticoduodenectomy (v2.0)

Sponsor

Asan Medical Center (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06009224

Collaborator

(none)

334

Enrollment

Location

Arms

Anticipated Duration (Months)

11.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Periampullary Cancer Borderline Malignancy Tumor	Other: ERAS perioperative management	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

334 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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.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.

Masking:

Single (Outcomes Assessor)

Masking Description:

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.

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Sep 1, 2023

Anticipated Primary Completion Date :

Jun 30, 2025

Anticipated Study Completion Date :

Dec 31, 2025

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Functional recovery date on postopreative 7th day [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

Secondary Outcome Measures

Postoperative complication [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).
Postoperative mortality [90 days after surgery]
All in-hospital mortality and 90 days mortality
Re-admission rate [3 months after surgery]
For any reason, all readmitted patients are included.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Division of Hepatobiliary and Pancreatic Surgery, Department of Surgery, Asan Medical Center, University of Ulsan College of Medicine	Seoul		Korea, Republic of	05505