PROTOCOL

 OBJECTIVE                                                                                                                                    

To conduct a retrospective multicenter cohort study to define benchmark values for best achievable outcomes following robotic distal pancreatectomy (RDP). Importantly, center specific learning curves will be analyzed and the final benchmark cohort will consist of patients after the learning curve.

 INTRODUCTION                                                                                                                              

With the growing complexity and costs of modern surgical practice, convincing and unbiased quality assessment becomes mandatory. The notion of quality assessment is widely recognized and used in the world of business and manufacturing. A possible tool of quality assessment is benchmarking. Benchmarking is a process of measuring performance in order to enable for outcome comparison and improvement within a specific domain. In the surgical community, however, such standard outcome measures and multicenter comparison of results have been poorly developed and benchmarking for the best possible results for specific procedures is lacking.

The first landmark study defining benchmark outcomes for liver resection was presented at the 2016 ASA meeting in Chicago and published in Ann Surg (Rössler et al., Ann Surg, 2016). More recently benchmark values were established for liver transplantation (Muller et al., Ann Surg, 2018), esophagectomy (Schmidt et al., Ann Surg, 2017), pancreas surgery (Sánchez-Velázquez et al., Ann Surg, 2019), bariatric surgery (Gero et al., Ann Surg, 2019) and ALPPS (Raptis et al., Ann Surg, 2019).

Distal pancreatectomy is the preferred treatment of body-tail tumors of the pancreas. Previously, this procedure was performed via an open approach, however, the minimally invasive platform has gained acceptance since the first description of laparoscopic DP (LDP) in 1996 and first robotic DP (RDP) in 2003. Recent studies have reported that RDP results in comparable oncologic short term outcome with a lower morbidity rate, better cosmetic satisfaction, shorter hospital stay and faster recovery. To identify the best possible outcome (i.e. benchmarking), data from high-volume centers in low risk patients will be analyzed. These benchmark outcomes will serve as “controls” for comparison with any future analyses of RDP. 

 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.

In the ideal case there will be one junior author who will coordinate data collection with Dr. Philip Müller, Dr. Eva Breuer (coordinators of the study from Zurich).

Further use of cohort data: Future studies based on the collected data will hopefully emerge from this multicenter study.

METHODS                                                                                                                                       

Benchmark Values:

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

Study period

  • Start RDP program -June 30th 2020.

Center eligibility

  • >50 annual pancreatic procedures per center (including open, laparoscopic, robotic)
  • At least 10 robotic distal pancreatectomies per year over the last 3 years
  • Prospective database available

Patient eligibility (benchmark cases criteria)

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

Inclusion criteria:

  1. Adults ≥ 18 years
  2. RDP for resectable malignant and benign pancreatic disease (any indication)

Exclusion criteria:

  1. Resection of the mesenteric artery/celiac trunk
  2. Concomitant resection of adjacent organs other than the spleen or the adrenal gland (extended resection)

Governance

Data will be collected via a secure; password protected, and encrypted online data management system, provided by the University Hospital of Zurich. 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 study coordinators in Zurich (Dr. Philip Müller, Dr. Eva Breuer). 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