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.

Sex

All

Minimum age

18 Years

Maximum age

80 Years

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

• RESULTHwang DW, Kim HJ, Lee JH, Song KB, Kim MH, Lee SK, Choi KT, Jun IG, Bang JY, Kim SC. Effect of Enhanced Recovery After Surgery program on pancreaticoduodenectomy: a randomized controlled trial. J Hepatobiliary Pancreat Sci. 2019 Aug;26(8):360-369. doi: 10.1002/jhbp.641. Epub 2019 Jul 2. PMID 31152686
• RESULTMelloul E, Lassen K, Roulin D, Grass F, Perinel J, Adham M, Wellge EB, Kunzler F, Besselink MG, Asbun H, Scott MJ, Dejong CHC, Vrochides D, Aloia T, Izbicki JR, Demartines N. Guidelines for Perioperative Care for Pancreatoduodenectomy: Enhanced Recovery After Surgery (ERAS) Recommendations 2019. World J Surg. 2020 Jul;44(7):2056-2084. doi: 10.1007/s00268-020-05462-w. PMID 32161987
• RESULTFeldheiser A, Aziz O, Baldini G, Cox BP, Fearon KC, Feldman LS, Gan TJ, Kennedy RH, Ljungqvist O, Lobo DN, Miller T, Radtke FF, Ruiz Garces T, Schricker T, Scott MJ, Thacker JK, Ytrebo LM, Carli F. Enhanced Recovery After Surgery (ERAS) for gastrointestinal surgery, part 2: consensus statement for anaesthesia practice. Acta Anaesthesiol Scand. 2016 Mar;60(3):289-334. doi: 10.1111/aas.12651. Epub 2015 Oct 30. PMID 26514824
• RESULTKuemmerli C, Tschuor C, Kasai M, Alseidi AA, Balzano G, Bouwense S, Braga M, Coolsen M, Daniel SK, Dervenis C, Falconi M, Hwang DW, Kagedan DJ, Kim SC, Lavu H, Liang T, Nussbaum D, Partelli S, Passeri MJ, Pecorelli N, Pillai SA, Pillarisetty VG, Pucci MJ, Su W, Sutcliffe RP, Tingstedt B, van der Kolk M, Vrochides D, Wei A, Williamsson C, Yeo CJ, Zani S, Zouros E, Abu Hilal M. Impact of enhanced recovery protocols after pancreatoduodenectomy: meta-analysis. Br J Surg. 2022 Feb 24;109(3):256-266. doi: 10.1093/bjs/znab436. PMID 35037019
• RESULTLee JH, Kim DH, Koh WU. Real-time ultrasound guided thoracic epidural catheterization: a technical review. Anesth Pain Med (Seoul). 2021 Oct;16(4):322-328. doi: 10.17085/apm.21060. Epub 2021 Oct 29. PMID 34289297
• RESULTKim HE, Kim YH, Song KB, Chung YS, Hwang S, Lee YJ, Park KM, Kim SC. Impact of critical pathway implementation on hospital stay and costs in patients undergoing pancreaticoduodenectomy. Korean J Hepatobiliary Pancreat Surg. 2014 Feb;18(1):14-20. doi: 10.14701/kjhbps.2014.18.1.14. Epub 2014 Feb 24.