Clinical trial · Observational
How Does Pre-operative Biliary Drainage in Pancreatic Adenocarcinoma Affect Surgical Outcomes in Pancreatic Cancer Surgery
Pre-operative Biliary Drainage in Pancreatic Adenocarcinoma and Its Effect on Surgical Oncological Outcomes
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Pre-operative biliary drainage (PBD) is a procedure used to relieve bile duct obstruction, a common issue in patients with pancreatic cancer. The obstruction occurs when a tumor blocks the bile duct, leading to jaundice and other complications. While PBD can help resolve jaundice and improve liver function, its impact on the overall outcomes of pancreatic cancer surgery is still debated. Recent research has focused on whether PBD before surgery improves patient outcomes, such as surgical success, recovery time, and long-term survival. Some studies suggest that draining the bile before surgery might reduce complications like infections, liver dysfunction, and jaundice-related risks. On the other hand, other research indicates that PBD could increase the chances of infection, delays in surgery, or complications from the procedure itself, such as bile leakage or inflammation. This study will look at patients undergoing pancreaticoduodenectomy to remove their head of pancreas pancreatic ductal adenocarcinoma over 8 years, and will compare the tumour characteristics of patients who have had PBD vs those who have not. Data will be gathered from the already available histological characteristics. No treatment would be affected and no tissue would be affected. This research study will focus on oncological characteristics such as tumour progression and lymphatic spread, with overall patient survival as secondary outcome measures.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Ductal Adenocarcinoma (mPDAC) | Pancreatic Ductal Adenocarcinoma | ONTOLOGY_EXACT | 0.85 |
| Pancreatic Ductal Adenocarcinoma (PDAC) | Pancreatic Ductal Adenocarcinoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pre operative biliary drainage | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Preoperative biliary drainage
- description
- Patients who undergo pre op biliary drainage before surgery
- interventionNames
- Procedure: Pre operative biliary drainage
- label
- No pre operative biliary drainage
- description
- Patients who proceed straight to surgery
Primary outcomes (1)
- measure
- lymph Node ratio
- timeFrame
- From the day of resection
- description
- From pathology report
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Procedure - Pancreaticoduodenectomy * Histology - Pancreatic ductal adenocarcinoma at East Lancashire Hospitals NHS Trust * Age \> 18 years Exclusion Criteria: Patients \< 18 years of age Patients who had pancreaticoduodenectomy for benign disease Patients who had pancreaticoduodenectomy with any histology other than pancreatic ductal adenocarcinoma Patients who underwent any other procedure for head of pancreas pancreatic ductal adenocarcinoma Patients who have opted out from being part of research as per the MESH database
References
Publications (6)
- BACKGROUNDSewnath ME, Karsten TM, Prins MH, Rauws EJ, Obertop H, Gouma DJ. A meta-analysis on the efficacy of preoperative biliary drainage for tumors causing obstructive jaundice. Ann Surg. 2002 Jul;236(1):17-27. doi: 10.1097/00000658-200207000-00005. PMID 12131081
- BACKGROUNDvan der Gaag NA, Rauws EA, van Eijck CH, Bruno MJ, van der Harst E, Kubben FJ, Gerritsen JJ, Greve JW, Gerhards MF, de Hingh IH, Klinkenbijl JH, Nio CY, de Castro SM, Busch OR, van Gulik TM, Bossuyt PM, Gouma DJ. Preoperative biliary drainage for cancer of the head of the pancreas. N Engl J Med. 2010 Jan 14;362(2):129-37. doi: 10.1056/NEJMoa0903230. PMID 20071702
- BACKGROUNDNadeem SO, Jajja MR, Maxwell DW, Pouch SM, Sarmiento JM. Neoadjuvant chemotherapy for pancreatic cancer and changes in the biliary microbiome. Am J Surg. 2021 Jul;222(1):3-7. doi: 10.1016/j.amjsurg.2020.09.042. Epub 2020 Oct 5. PMID 33039150
- BACKGROUNDFang Y, Gurusamy KS, Wang Q, Davidson BR, Lin H, Xie X, Wang C. Pre-operative biliary drainage for obstructive jaundice. Cochrane Database Syst Rev. 2012 Sep 12;2012(9):CD005444. doi: 10.1002/14651858.CD005444.pub3. PMID 22972086
- BACKGROUNDBlacker S, Lahiri RP, Phillips M, Pinn G, Pencavel TD, Kumar R, Riga AT, Worthington TR, Karanjia ND, Frampton AE. Which patients benefit from preoperative biliary drainage in resectable pancreatic cancer? Expert Rev Gastroenterol Hepatol. 2021 Aug;15(8):855-863. doi: 10.1080/17474124.2021.1915127. Epub 2021 May 26. PMID 34036856
- BACKGROUNDHartwig W, Werner J, Jager D, Debus J, Buchler MW. Improvement of surgical results for pancreatic cancer. Lancet Oncol. 2013 Oct;14(11):e476-e485. doi: 10.1016/S1470-2045(13)70172-4. PMID 24079875