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2023-09-01
2025-06-30
2025-12-31
334
NCT06009224
Asan Medical Center
Asan Medical Center
INTERVENTIONAL
The Effect of ERAS on Pancreaticoduodenectomy (v2.0)
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.
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.
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 Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2022-11-16 | N/A | 2023-08-22 |
2023-08-22 | N/A | 2023-08-24 |
2023-08-24 | N/A | 2023-08 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Randomized
Interventional Model:
Parallel
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
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Functional recovery date on postopreative 7th day | * 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 | Measure Description | Time Frame |
|---|---|---|
| Postoperative complication | 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 | All in-hospital mortality and 90 days mortality | 90 days after surgery |
| Re-admission rate | For any reason, all readmitted patients are included. | 3 months after surgery |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Dae Wook Hwang, M.D., PhD Phone Number: 82230103939 Email: drdwhwang@gmail.com |
Study Contact Backup Name: Min Kyu Sung, M.D. Phone Number: 82230100541 Email: skystar8608@naver.com |
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.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
