The Effect of ERAS on Pancreaticoduodenectomy (v2.0)

Trial Title: The Effect of ERAS on Pancreaticoduodenectomy (v2.0)

NCT ID: NCT06009224

Condition: Periampullary Cancer
Borderline Malignancy Tumor

Conditions: Official terms:
Neoplasms

Conditions: Keywords:
Enhanced Recovery After Surgery
Pancreaticoduodenectomy
Periampullary cancer
Fast track surgery
Postoperative complication

Study type: Interventional

Study phase: N/A

Overall status: Not yet recruiting

Study design:

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.

Primary purpose: Treatment

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.

Intervention:

Intervention type: Other
Intervention name: ERAS perioperative management
Description: - Epidural analgesia - Fluid balance - Other items are the same as conventional
Arm group label: Experimental

Other name: Fast tract

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.

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.

Criteria for eligibility:
Criteria:
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

Gender: All

Minimum age: 18 Years

Maximum age: 80 Years

Healthy volunteers: No

Locations:

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

Address:
City: Seoul
Zip: 05505
Country: Korea, Republic of

Start date: September 1, 2023

Completion date: December 31, 2025

Lead sponsor:
Agency: Asan Medical Center
Agency class: Other

Source: Asan Medical Center

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06009224