Status:
UNKNOWN
The Effect of ERAS on Pancreaticoduodenectomy (v2.0)
Lead Sponsor:
Asan Medical Center
Conditions:
Periampullary Cancer
Borderline Malignancy Tumor
Eligibility:
All Genders
18-80 years
Phase:
NA
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...
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). Th...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
334 Patients enrolled
Trial Details
Trial ID
NCT06009224
Start Date
September 1 2023
End Date
December 31 2025
Last Update
August 24 2023
Active Locations (1)
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1
Division of Hepatobiliary and Pancreatic Surgery, Department of Surgery, Asan Medical Center, University of Ulsan College of Medicine
Seoul, South Korea, 05505