The Effect of ERAS on Pancreaticoduodenectomy (v2.0)

Asan Medical Center

Status

Not yet enrolling

Conditions

Periampullary Cancer

Borderline Malignancy Tumor

Treatments

Other: ERAS perioperative management

Study type

Interventional

Funder types

Other

Identifiers

NCT06009224

2022-1204

Details and patient eligibility

About

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.

Full 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.

Enrollment

334 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No 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