Robotic Versus Open Pancreaticoduodenectomy for Pancreatic and Periampullary Tumors

Daily evaluation of patient postoperative course will take place by the nursing and medical staff and will be documented by the study coordinators. Postoperative criteria that need to be fulfilled independently to achieve functional recovery status are the following:

• Discontinuation of intravenous or subcutaneous analgesia and preservation of adequate control levels (pain score)
• Early ambulation and restoration of mobility to an independent level (or to preoperative level if previously impaired)
• Ability to maintain sufficient oral caloric intake as defined by institutional dietitian services, without intravenous fluid support
• No clinical signs of active abdominal infection affecting the patient's performance status: absence of fever, white cell count and C-reactive protein decreasing towards normalization. The patient can be in oral antibiotics.

Comparison of estimated blood loss (in ml)

Comparison of operative time (in minutes, from first incision to skin closure)

The number of patients who are fit and well to initiate adjuvant chemotherapy at the 8-week mark after the operation will be documented and compared between the two arms

Comparison of post-pancreatectomy morbidity between the two surgical approaches, that focus on:

• Pancreatic fistula
• Bile leak
• Chyle leak
• Delayed gastric emptying
• Surgical site infection
• Postoperative pancreatitis
• Postoperative hemorrhage
• Surgical site infections
• Other complications Additional documentation of re-intervention (radiological, endoscopic, or surgical) and re-admission rates, as well as postoperative hospital and ICU length of stay (time to discharge)

Comparison of mortality rates as a result of the pancreaticoduodenectomy in each arm

For assessment of postoperative quality of life (QoL) improvement, patients will be evaluated with the established EuqoQol EQ-5D-5L questionnaire, which is a self-reported assay focusing on five parameters: Pain/discomfort, anxiety/depression, usual activities, self-care, and mobility. Each of the five aforementioned parameters is scored from 0 to 5 (no issue, slight problem, moderate problem, severe problem, unable); patients also score independently their health status on a scale numbered from 0 to 100; 100 means the best health they can imagine, and 0 the worst.

Answered questionnaires will be collected on postoperative days 1, 3, 5, 7, and afterwards every week until day 30. QoL evaluation will terminate at Day 90.

In a sub-cohort of patients with pancreatic adenocarcinoma, the margin resection status (R) will be assessed and compared: R0 is defined as presence of tumor >1mm from the resection margin, R1 as presence of tumor ≤1mm from the resection margin.

• Number of harvested lymph nodes
• Number of positive lymph nodes (infiltrated by tumor)
• Tumor size, degree of differentiation, perineural and lymphovascular invasion

In a sub-cohort of patients with pancreatic adenocarcinoma, the number of harvested and positive lymph nodes (infiltrated by tumor) will be assessed and compared between the two groups.

Patients with pancreatic adenocarcinoma who undergo resection in each arm will be followed postoperatively to document disease recurrence, defined as the re-presentation of measurable tumor after resection.

Patients with pancreatic adenocarcinoma who undergo resection in each arm will be followed postoperatively to document overall survival, defined as the time between date of operation and date of death.

Comparison of cost between the two groups, defined as the combination of intraoperative and postoperative costs, measured in US Dollars.