An interventional study of ERAS perioperative management in Periampullary Cancer and Borderline Malignancy Tumor, sponsored by Asan Medical Center. Not yet recruiting at 1 site in Korea, Republic of. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-08-24.
Sponsored by Asan Medical Center · Not applicable, Interventional, and Treatment
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.
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's planned enrollment of 334 is above the median of 50 across 7,253 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →Asan Medical Center is the lead sponsor of 562 studies on the registry; 71 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Conventional ERAS program
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
Also known as: Fast tract
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
Time frame: 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.
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).
Time frame: Three months after surgery
Postoperative mortality
All in-hospital mortality and 90 days mortality
Time frame: 90 days after surgery
Re-admission rate
For any reason, all readmitted patients are included.
Time frame: 3 months after surgery
Plan to share: Undecided — It can be determined in accordance with the Personal Information Protection Act of KOREA and institutional data sharing regulations.
This study is not yet recruiting, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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Asan Medical Center