Pancreatic cancer, bile duct cancer, duodenal cancer, ampullary carcinoma, IPMN, NET, etc Pancreatic cancer, bile duct cancer, duodenal cancer, ampullary carcinoma, intraductal papillary mucinous neoplasm (IPMN), neuroendocrine tumor, and metastatic pancreatic tumor.
Conditions
Interventions
An intervention comparing pancreaticoduodenectomy performed via robotic-assisted surgery versus open surgery.
D016577
pancreaticoduodenectomy
Sponsors
Inoue Yosuke
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients scheduled for elective pancreaticoduodenectomy for pancreatic head region tumors without radiographic evidence of invasion into major vessels (such as the portal vein, hepatic artery, or superior mesenteric artery). (a) Pancreatic head region tumors include the following conditions: Pancreatic cancer, Bile duct cancer, Duodenal cancer, Ampullary carcinoma, Intraductal papillary mucinous neoplasm (IPMN), Neuroendocrine tumor, Metastatic pancreatic tumor. (b) Preoperative pathological diagnosis is not mandatory. Patients whose postoperative pathology shows non-neoplastic lesions are also eligible. 2. Age at the time of informed consent: 20 to 85 years 3. ECOG Performance Status (PS): 0-1 4. Adequate major organ function (bone marrow, liver, kidney, lung, etc.): (A) White blood cell count: >=2,500/mm3 and =8.5 g/dL (C) Platelet count: >=100,000/mm3 (D) Total bilirubin: <=2.0 mg/dL (E) Creatinine: <=2.0 mg/dL 5. Sufficient cognitive ability to understand the study, with written informed consent obtained from the patient.
Exclusion criteria
Exclusion criteria: 1. Patients with suspected radiographic contact of major vessels (such as the portal vein, hepatic artery, or superior mesenteric artery) where vascular reconstruction may be required. 2. Patients who have received radiotherapy for pancreatic cancer. 3. Patients with a history of upper abdominal surgery (excluding cholecystectomy). 4. Patients with body mass index (BMI) > 30. 5. Patients with a history of acute pancreatitis >=3 episodes, or those deemed ineligible by the principal investigator for other reasons. 6. Patients who have undergone invasive endoscopic ultrasound (EUS)-guided biliary drainage (including EUS-guided hepaticogastrostomy or choledochoduodenostomy) or percutaneous interventions. Not excluded: Endoscopic nasobiliary drainage (ENBD), endoscopic retrograde biliary drainage (ERBD) stent placement, or standard EUS-guided fine-needle aspiration (EUS-FNA). 7. Patients with severe ischemic heart disease. 8. Patients with liver cirrhosis or active hepatitis. 9. Patients with respiratory insufficiency requiring oxygen therapy due to interstitial pneumonia, pulmonary fibrosis, or similar conditions. 10. Patients with chronic renal failure requiring dialysis. 11. Patients requiring combined resection of surrounding organs (e.g., liver, colon). 12. Patients receiving continuous systemic corticosteroids or immunosuppressive therapy. 13. Patients with severe drug allergies. 14. Patients with active concomitant malignancy considered likely to affect adverse events. 15. Patients scheduled to receive octreotide. 16. Patients with psychiatric disorders or symptoms that make participation in the study difficult. 17. Patients with substance or alcohol dependence.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of postoperative complications of Clavien-Dindo grade 3a or more in the intervention group. | — |
Secondary
| Measure | Time frame |
|---|---|
| Surgical Data: Blood loss, Operative time, Intraoperative adverse events, Conversion rate from Robot PD to open surgery Postoperative Complications: Comparison of postoperative complication rates between Robot PD and open PD, Postoperative drain amylase levels, Duration of drain placement, Postoperative hospital stay, Incidence of pancreatic fistula overall (biochemical leakage, Grade B, Grade C), Incidence of delayed gastric emptying, Incidence of bile leak, Incidence of postoperative intra-abdominal abscess, Incidence of postoperative hemorrhage, Rate of drain reinsertion, Overall postoperative complication rate, Incidence of Clavien Dindo grade 3a or more complications, Surgery-related mortality within 90 days, Reoperation rate, Readmission rate within 90 days, Postoperative quality of life assessed via questionnaire at 2 weeks and 6 months Pathological Evaluation: R0 resection rate (0 mm), Number of lymph nodes resected, Number of metastatic lymph nodes, Tumor differentiation, Vascular invasion Mid- to Long-Term Outcomes: Rate of postoperative chemotherapy initiation for pancreatic cancer or other indications, Interval from surgery to start of postoperative chemotherapy, Recurrence-free survival rate Economic Outcomes: Surgical costs, Total hospitalization costs | — |
Contacts
Public ContactKosuke Kobayashi
Division of Hepato-Biliary-Pancreatic Surgery, Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo, Japan
Outcome results
None listed