The Effect of ERAS on Pancreaticoduodenectomy

Not Applicable

Completed

Brief Summary: Enhanced Recovery After Surgery (ERAS) is not the program that aim 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 is proved in many surgical procedures, such as upper gastrointestinal surgery and colorectal surgery. However, pancreaticoduodenectomy (PD, Whipple's operation) is still one of most complex abdominal surgery, and there is no evidence that ERAS is beneficial on PD.

This study investigate the clinical effectiveness of ERAS on PD.

Detailed Description: * This study conduct totally 276 patients who underwent PD with borderline or malignant periampullary tumor. The patients divided into two groups. One group take conventional, experienced-based perioperative management, the other group take perioperative management based on ERAS protocol. Applied ERAS protocol is based on "Guidelines for Perioperative Care for Pancreaticoduodenectomy: Ehanced Recovery After Surgery Society Recommendations.

* The outcomes are analyzed for short-term surgical outcomes including operative factors, nutritional status, morbidity, mortality, length of stay, readmission, etc.

* Among all subjects who were randomized and started any study intervention (ERAS or standard perioperative management), the patients who underwent pancreaticoduodenectomy were included as the Full analysis set (FAS). All subjects who didn't undergo pancreaticoduodenectomy were excluded from this study.

* Besides, as 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 were not defined differently

Recruitment & Eligibility

Inclusion Criteria

>18 years old or <75 years old
ECOG 0-2
resectable periampullary cancer or borderline malignancy
no distant metastasis
no functional disturbance in bone marrow; WBC at least 3,000/mm3 or absolute neutrophil count at least 1,500/mm3, Platelet count at least 125,000/mm3
no functional disturtance in liver; Bilirubin less than 2.5 mg/dL AST less than 5 times upper limit of normal
no function disturbance in kidney; Creatinine no greater than 1.5 times upper limit of normal
informed consent

Exclusion Criteria

distant metastasis (+) or recurred periampullary tumor
active or uncontrolled infection
uncontrolled psychiatric or neurologic problems
alcohol or other drug addiction
already enrolled patient in other study which affect this study
the patient who is impossible to allow investigator's order
pregnant or the possibility of pregnancy (+)
uncontrolled cardiopulmonary disease
moderate to severe comorbidity which affect on the quality of life and nutritional status (liver cirrhosis, end stage renal disease, heart failure, etc.)
previous history of major gastrointestinal surgery (gastrectomy, colectomy, etc.)
in preoperative period, expected combined resection of other gastrointestinal organ including portal vein

Arm && Interventions

Group	Intervention	Description
ERAS perioperative management	ERAS perioperative management	* behavioral intervention (counselling, audit) * dietary supplement * procedure (preoperative and postoperative) * drug

Primary Outcome Measures

Name	Time	Method
Morbidity	3 months	The incidence of operation-related morbidity

Secondary Outcome Measures

Name	Time	Method
Mortality	3 months	The incidence of 30 days mortality and in-hospital mortality
length of stay	3 months	postoperative length of stay
nutritional status	3 months	The nutritional status would be analyzed by the comparison of PG-SGA score, body mass index and assessment of daily oral intake at preoperative, before discharge and postoperative 2\~3months.

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