PROTOCOL

OBJECTIVE

To conduct a retrospective multicenter cohort study to define benchmark values for best achievable outcomes following robotic pancreatoduodenectomy (RPD). 

POLICY SECURING

Confidential center specific data: No center-specific data will be published. Instead, all complications or adverse outcomes will be anonymously reported, as fractions of the total study population. Each center, of course, will be free to publish their own data, as they wish.

Authorship: No data will be submitted or published without authorization from each participating center. Each center will be represented by its contributors including two co-authorships per center.

In the ideal case there will be one junior author who will coordinate data collection with PD Dr. Felix Nickel (Principal investigator and coordinator of the study from Hamburg). 

Further use of cohort data: Future studies based on the collected data will hopefully emerge from this multicenter study and will only be conducted with authorization from each participating center.

METHODS

Benchmark Values:

  1. Mortality 30 and 90 days
  2. Morbidity
  3. Operation characteristics
    • Duration of surgery
    • Blood loss
    • R0 resection
    • Number of harvested lymph nodes
    • Conversion to open surgery
  4. Length of stay (ICU), length of stay (hospital)
  5. Readmission
  6. Disease free survival (DFS) and Overall survival (OS) (reported at one and 3 years) for malignant indications

Study period:

  • 06/2003 – 06/2023

Center eligibility:

  • Minimum of 50 annual pancreatic procedures per center 
  • Prospective database available with a minimum of 40 RPDs

Patient eligibility (benchmark cases criteria):

Please note that, at this stage, the study will include all consecutive RPD cases (benchmark and non-benchmark cases).

Inclusion criteria:

  1. Adults ≥ 18 years
  2. RPD (any indication)

Exclusion criteria:

  1. Primary open or laporoscopic procedures
  2. PD in emergency setting

GOVERNANCE

Data will be collected via a secure; password protected, and encrypted online data management system. This platform uses a data entry management system (DEMS) to meet international standards for online databases including fully anonymous data. Data will not be published with hospital identifiers.

DATA COLLECTION

Local collaborators: Most hospitals will have two local investigators; a senior and a junior investigator. The junior collaborator will be in regular contact with the principal investigator and study coordinator in Hamburg (PD Dr. Felix Nickel). The junior investigator will be responsible for:

  • Gaining local research ethics approval
  • Identifying and including all eligible patients
  • Accurately collect baseline and follow-up data
  • Submit data to the online DEMS database