Periampullary Tumor
Conditions
Keywords
pancreaticoduodenectomy, ERAS, Whipple's operation, Fast track
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
Interventions
* Preop Counseling * Preop biliary drainage (X) when Serum Total bilirubin \< 14.62mg/dl and cholangitis (-) * Preop enteral nutrition * Oral bowel preparation (mechanical bowel preparation ) (X) * Preop fasting \< 6 hours * Prevention of postoperative nausea and vomiting (PONV) (O) * Nasogastric intubation (X) * Near-zero fluid balance * Somatostatin analogues (X) * Postop routine artificial nutrition (X), soft diet at POD #2 * Audit * Other items are same as conventional
Sponsors
Asan Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
The evaluation and judgement for morbidity (primary endpoint) / mortality (secondary endpoint) was made by Morbidity and Mortality Committee in our division. Committee members were blinded about knowledge of the interventions assigned to individual participants.
Intervention model description
Two study groups (Control (conventional) group and study (intervention) group) were randomly allocated and assigned to one of two groups in parallel for the whole duration of this study.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Morbidity | 3 months | The incidence of operation-related morbidity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
South Korea
Outcome results
None listed