Table 1.
Study period | |||||||
Time point Items |
Preoperative eligibility assessment | Allocation | Intraoperatively | Before discharge postoperatively | Follow-up | Close-out | |
First month postoperatively | 1st month postoperatively | 3rd month postoperatively | 1st year postoperatively | ||||
Patient demographics | ✓ | ||||||
Informed consent | ✓ | ||||||
Blood routine | ✓ | ✓ | |||||
Coagulation routine | ✓ | ||||||
Blood biochemistry | ✓ | ✓ | |||||
Enhanced CT scan | ✓ | ✓ | |||||
Allocation record | ✓ | ||||||
Surgical videos | ✓ | ||||||
Surgical record | ✓ | ||||||
Postoperative records | ✓ | ✓ | ✓ | ✓ | |||
Histopathological findings | ✓ | ✓ | |||||
Other therapy (if necessary) | ✓ | ✓ | ✓ | ✓ |
Patient demographics includes date of admission, year of birth, sex, body mass index, previous surgical history, preoperative biliary drainage, Nutrition risk score, WHO-ECOG score, location of the tumour, diameter of the tumour, diameter of the main pancreatic duct, history of neoadjuvant therapy, and pancreatic thickness. Surgical record includes date of operation, ASA scores, location of the pancreatic neck transection (extended or conventional pancreatic neck transection), pancreatic texture, diameter of the main pancreatic duct, duration of pancreaticojejunostomy anastomosis, duration of the operation, estimated blood loss, whether to convert to open surgery or other procedures, whether to preserve the pylorus, whether to resect and reconstruct the main veins and variation of vessels. Postoperative records include blood transfusion, date of soft solid diet, date of drain removal, date of nasogastric tube removal, drain and production amylase, date of discharge, type of complication, reoperation and Clavien-Dindo grade, cost for hospitalisation, and short-term and long-term pancreatic exocrine and endocrine function. Histopathological findings include location of the tumour, size of the tumour, histological type, surgical margin status and the T&N classification and American Joint Committee on Cancer staging for malignant tumours. Other therapy includes readmission, treatment for any surgical complications, adjuvant therapy for malignant tumours and the cost for readmission.