The Effect of ERAS on Pancreaticoduodenectomy

Asan Medical Center

Status: Completed

Conditions: Periampullary Tumor

Treatments: Other: ERAS perioperative management

Study type: Interventional

Funder types: Other

Identifiers

NCT02372331

ERAS

Details and patient eligibility

About

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.

Full 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

Enrollment: 276 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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276 participants in 2 patient groups

Conventional perioperative management

No Intervention group

Description:

* Preop usual biliary drainage * Preop smoking and alcohol * Preop parenteral nutrition * Oral bowel preparation (mechanical bowel preparation ) * Preoperative fasting \> 12 hours * Pre-anesthetic medication * Anti-thrombotic prophylaxis * Antimicrobial prophylaxis and skin preparation * Intravenous analgesia : PCA * Prevention of postoperative nausea and vomiting (PONV) (X) * Incision : surgeon direction * Avoiding hypothermia * Nasogastric intubation (O) * Postop glycemic control * Positive fluid balance * Perianastomotic drain removal over POD #5 * Somatostatin analogues * Transurethral catheter removal * Delayed gastric emptying(DGE) (+) , parenteral nutrition (+) * Postop routine artificial nutrition (O), soft diet at POD #5 * Early and scheduled mobilization

ERAS perioperative management

Experimental group

Description:

* behavioral intervention (counselling, audit) * dietary supplement * procedure (preoperative and postoperative) * drug

Treatment:

Other: ERAS perioperative management