Background
Methods/design
Study aim
Patient involvement
Eligibility criteria
Inclusion criteria
Exclusion criteria
Withdrawal
Ethics, study registration, and consent
Trial interventions
One-layer duct-to-mucosa PJ anastomosis
Two-layer duct-to-mucosa PJ anastomosis
Primary and secondary endpoints
Primary endpoint
Secondary endpoints
Secondary endpoint | Definition and assessment of outcomes |
---|---|
Anastomosis time | Time from beginning to end of PJ anastomosis |
Mortality | Death due to any cause until 90 days after the operation and the reason |
Morbidity | Postoperative complications will be recorded until 90 days after operation. The severity of complications will be graded according to the Clavien-Dindo classification [18] |
Postoperative hospital stay | Time from day of operation until discharge (days) |
Postpancreatectomy hemorrhage | Evidence of blood loss from drains and/or nasogastric tube, based on ultrasonography, as defined by ISGPS [19] |
Biliary leak | Bilirubin concentration in the drain fluid at least three times the serum bilirubin concentration as defined by International Study Group of Liver Surgery [20] |
Delayed gastric emptying | Failure to resume solid diet with prolonged need for nasogastric tube as defined by ISGPS [21] |
Intra-abdominal fluid collection | Collection of fluid measuring ≥3 cm associated with clinical or laboratory abnormalities |
Wound infection | Surgical site infection associated with laparotomy that develops during the initial hospital stay |
Pneumonia | Presence of a new infiltrate on chest X-ray, as well as following: body temperature >38 °C, abnormal elevation of white blood cells, or positive sputum, and requiring antibiotic treatment |
Abdominal rupture | Dehiscence of abnormal closure with need for resuture of the laparotomy during the initial hospital stay |
Grade | Definition |
---|---|
I | Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic, and radiological intervention |
II | Requiring pharmacological treatment with drugs other than those allowed for grade I complications |
III | Requiring surgical, endoscopic, or radiological intervention |
IIIa | Intervention not under general anesthesia |
IIIb | Intervention under general anesthesia |
IV | Life-threatening complication. Requiring intensive care unit management |
IVa | Single organ dysfunction |
IVb | Multi-organ dysfunction |
V | Death of patient |
Type of trial
Randomization
Blinding
Data management and quality assurance
Screening | ||||||
---|---|---|---|---|---|---|
Visit 1 | Visit 2 | Visit 3 | Visit 3 | Visit 3 | Visit 4 | |
Before surgery | Day of surgery | (PODb 1) | (POD 3) | (POD 7) | (POD 90) | |
Selection criteria | ||||||
Informed consent | × | |||||
Past medical history | ||||||
Personal dataa
| × | |||||
Physical examination | × | |||||
Laboratory tests | × | × | × | × | × | |
Trial intervention | × | |||||
Intraoperative outcomes | × | |||||
Postoperative outcomes | × | × | × | × |