Spleen Preservation Versus Splenectomy in Left Pancreatectomy for Pancreatic Ductal Adenocarcinoma (SPLENDID)

Clavien-Dindo classification grade ≥3

• Diagnostic laparoscopy performed (yes vs no);

• Postoperative pancreatic fistula (grade B/C);
• Post-pancreatectomy hemorrhage (grade B/C);
• Delayed gastric emptying (grade B/C);
• Post-pancreatectomy acute pancreatitis (grade B/C);
• Chyle leak (grade B/C); All reported according to the ISGPS definitions

• Tumor size; mm

• (Neo-)adjuvant treatment; yes/no
• Recurrence: yes/no
• Treatment of recurrence: yes/no

• Metastatic disease; yes/no
• Overwhelming postoperative sepsis; yes/no
• Prophylactic or use of on-demand antibiotics; yes/no
• Vaccinations; yes/no
• Death. yes/no

EQ-5D-5L; Health states are converted into an index value using the prespecified value set. A value of 1 represents full health, 0 represents a health state equivalent to death, and negative values represent health states considered worse than death. Higher values indicate a better outcome. The possible minimum value is [insert minimum for the selected value set] and the maximum is 1.

QLQ-C30; Scale and single-item scores range from 0 to 100. Higher scores on the functional scales and global health status/quality-of-life scale indicate better functioning or quality of life, whereas higher scores on the symptom scales indicate more severe symptoms and therefore a worse outcome.

PAN26; Scale and single-item scores range from 0 to 100. Higher scores on symptom scales indicate more severe symptoms and therefore a worse outcome, whereas higher scores on the satisfaction with health care and sexuality functional scales indicate better functioning and therefore a better outcome.

• Type of left pancretectomy performed: Pancreatic Tail Resection (PTR), Pancreatic Body Tail Resection (PBRT), Panreatic Neck Body Tail Resection (PNBTR), Extended Pancreatic Neck Body Tail Resection (ePNBTR)

Conversion; yes/no, emergency of non emergency

Pancreatic duct size; mm

• Pancreatic texture; Soft/normal or Hard/Fibrotic

• Estimated intraoperative blood loss; mL

• Intraoperative blood transfusion; Yes/no and number of units transfused

• Total duration of the procedure; minutes

• Vascular resection; yes/no and specified which vessels

• Extended resection; yes/no and specify which additional organs are resected

• Serious intraoperative complications: Satava classification

• Non-surgical complications (including pulmonary complications); yes/no
• Surgical site infection; yes/no
• Postoperative re-intervention (radiological/endoscopic/surgical): yes/no
• Single- or multi organ failure; yes/no
• Need for secondary splenectomy; yes/no
• 30- and 90-day mortality; yes/no

• Histology grading; according to the royal collega of pathologists

• R0/1; according to royal college of pathologists

• Total lymph nodes retrieved and number of positive lymph nodes;

• Lymphovascular invasion and perineural invasion; yes/no

• TNM classification: Pathological tumour-node-metastasis (pTNM) stage according to the Union for International Cancer Control TNM Classification of Malignant Tumours, 8th edition. Stage groups range from stage 0 to IV, with higher stages indicating more advanced malignant disease and a worse outcome.