Periampullary tumors Cancer Malignant neoplasm of pancreas
Conditions
Interventions
Based on the included eligible patients with highly suspected periampullary tumors, the hospital statisticians will generate a random digital sequence using SAS 9.1 program (SAS Institute Inc., Cary,
Sponsors
Shenjing Hospital of China Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Periampullary tumors indicated by at least two imaging examinations or pathological biopsy before surgery 2. =18 years of age 3. Provision of written informed consent by patients or their legal guardians
Exclusion criteria
Exclusion criteria: 1. Extensive tumor metastasis 2. Abnormal blood coagulation 3. Renal dysfunction (creatinine >250 µmol/L) 4. Chronic liver disease 5. History of radiation therapy 6. American Society of Anesthesiologists (ASA) class IV-V 7. Life expectancy <48 hours 8. Lactating or pregnant women 9. Participation in other drug clinical trials
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of pancreatic fistula within 30 days after surgery (defined as an abdominal drain or incision output of fluid with an amylase level > 3 times the upper limit of institutional normal serum amylase activity for 3 days) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Incidence of postoperative hemorrhage within 30 days of surgery (defined as bloody drainage fluid, hematemesis, melena, unexplained hypotension or tachycardia, abnormal laboratory tests, and aggravated clinical manifestations) evaluated based on the results of gastrointestinal endoscopy, angiography, perfusion imaging, CT or re-operation 2. Incidence of delayed gastric emptying: 2.1. Grade A delayed gastric emptying: indwelling nasogastric tubes for 4-7 days after surgery or re-indwell nasogastric tubes 3 days after surgery because of nausea and vomiting or being unable to tolerate solid food 7-14 days after surgery 2.2. Grade B delayed gastric emptying: indwelling nasogastric tubes for 8-14 days after surgery or re-indwell nasogastric tubes 7 days after surgery, or being unable to tolerate solid food 14-21 days after surgery 2.3. Grade C delayed gastric emptying: indwelling nasogastric tubes for over 14 days or re-indwell nasogastric tubes 14 days after surgery or being unable to tolerate solid food 21 days after surgery 3. Surgical indicators: Patient’s operation time and intraoperative blood loss 4. Economic indicators: Patients’ average hospital stay and hospitalization cost | — |
Countries
China
Contacts
Public ContactXiaodong Tan
Outcome results
None listed