Pre-operative Biliary Drainage in Pancreatic Adenocarcinoma and Its Effect on Surgical Oncological Outcomes

1. INTRODUCTION 1.1 BACKGROUND Pancreatic cancer is the 10th most common cancer in the UK, responsible for the 5th largest cancer death rate (1). Oncological resection in the form of pancreatico-duodenectomy (PD) is the only curative treatment for pancreatic ductal adenocarcinoma (PDAC) affecting the head of pancreas (2). Significant prognostic factors for resected PDAC include R status, tumour size and differentiation, lymph node involvement, the presence of lymphovascular invasion (LVI) and perineural invasion (PNI).

While up to 70% of patients with PDAC in the head of pancreas have concurrent obstructive jaundice, there is much debate in recent years regarding the role of pre-operative biliary drainage (PBD) (3). PBD is used to treat the adverse effects of obstructive jaundice such as cholangitis, pro-inflammatory status, renal and cardiac dysfunction, hepatic dysfunction and coagulopathy, as well as a bridge to allow neoadjuvant therapy(3-5). Randomised control trials have shown that patients who routinely undergo PBD prior to PD experience a greater rate of complications(4, 6, 7).

1.2 Rationale for Current Study While there is an increasing amount of evidence demonstrating that PBD carries with it a risk of post operative complications, there is little evidence in the literature investigating if PBD affects oncological staging and disease progression (4, 6, 7). This retrospective study aims to investigate the effect of PBD on known markers of oncological disease severity, compared against patients who proceeded straight to surgery. 2. Study Objectives To identify level of correlation between PBD and oncological characteristics. 2.1 Study Outcomes It is expected that this study will provide essential information on the association between biliary drainage and oncological progression.

Primary Outcome Measures Lymph node Ratio Secondary Outcome Measures Presence of Perineural Invasion Presence of Lymphovascular Invasion Disease Free Survival Overall Survival Pancreatic Fistula Rate Resection Margin Status T Stage N Stage 3. Study Design and Data Collection Methods This will be a retrospective case note review, using data over an 8 year period 2014-2022. Patient information will be gained from the electronic patient record. Statistical analysis will then be performed after gathering information from the electronic patient record. There will be no change in patient care or patient interaction in this study. Subjects will be patients who underwent pancreaticoduodenectomy at ELHT for PDAC of the head of the pancreas. The number of patients is currently unknown. Data will be collected onsite at ELHT, a tertiary HPB referral centre. Data is stored on a secure hospital database that is password protected. A MESh check will be performed to check if patients have opted out from their data being used for research.

3.1 Study Outcome Measures Primary Outcome Measures Lymph node Ratio Secondary Outcome Measures Presence of Perineural Invasion Presence of Lymphovascular Invasion Disease Free Survival (days) Overall Survival (days) Pancreatic Fistula Rate (%) Resection Margin Status (R1/0) T Stage (T1-4) N Stage (N0-2) 3.2 Study Setting Data will be collected on East Lancashire Hospitals NHS Trust site on password protected trust computers. Data will be analysed using statistical analysis software such as SPSS or Jamovi. 4. Sample and Recruitment 4.1 Inclusion criteria