Outcomes and complications of biliary drainage for malignant biliary obstruction: National prospective study

Abstract

Background and study aims

National data suggest that biliary drainage for malignant obstruction is associated with high complication rates and early mortality. This study examined factors associated with poor outcomes.

Patients and methods

RICOCHET was a national, prospective audit of patients with pancreatic cancer or malignant biliary obstruction between April and August 2018. This analysis reviewed outcomes including complications within 7 days and 30-day mortality following biliary drainage and associated factors.

Results

Biliary drainage was attempted in 773 patients, of which, 78.7% were successful at first attempt; but if unsuccessful, only 37% of subsequent attempts succeeded. Complications occurred following 11% of endoscopic retrograde cholangiopancreatographies (ERCPs) (including pancreatitis, 5%) and 12% of percutaneous transhepatic biliary drainages (PTBDs) (including cholangitis, 8%). Complications were associated with: potentially resectable cancer (odds ratio [OR] 1.93, 95% confidence interval [CI] 1.23–3.03); more than one biliary drainage attempt (OR 1.69, 95% CI 1.04–2.74); cholangiocarcinoma (OR 2.20, 95% CI 1.20–4.05), or radiological cancer diagnosis (OR 2.02, 95% CI 1.13–3.60). Thirty-day mortality rates following ERCP and PTBD were 21.4% and 21.4%, respectively, in unresectable cancer and 6% and 6.3%, respectively, in potentially resectable cancer. Increased 30-day mortality in patients with unresectable disease was associated with a performance status of 2 or more (HR 3.14 (1.65–5.97)). Thirty-day mortality was significantly higher in patients with unresectable cancer if a multidisciplinary team meeting had not reviewed and advised drainage prior to the procedure 50% vs 20.4% (P = 0.028).

Conclusions

Careful multidisciplinary consideration of risks and potential benefits should be undertaken prior to attempting malignant biliary drainage due to the high risk of complications and early mortality.

Keywords

Cholangiopancreatography Endoscopic Retrograde - Percutaneous Transhepatic Biliary Drainage - Cholangiopancreatography - Endoscopic Retrograde/adverse effects - Percutaneous Transhepatic Biliary Drainage/complications - Mortality

Publikationsverlauf

Eingereicht: 02. Januar 2025

Angenommen: 05. März 2025

Artikel online veröffentlicht:
23. Juli 2025

• References

• 1 Andriulli A, Loperfido S, Napolitano G. et al. Incidence rates of post-ERCP complications: a systematic survey of prospective studies. Am J Gastroenterol 2007; 102: 1781-8
• 2 Kochar B, Akshintala VS, Afghani E. et al. Incidence, severity, and mortality of post-ERCP pancreatitis: a systematic review by using randomized, controlled trials. Gastrointest Endosc 2015; 81: 143-149.e9
• 3 Rees J, Mytton J, Evison F. et al. The outcomes of biliary drainage by percutaneous transhepatic cholangiography for the palliation of malignant biliary obstruction in England between 2001 and 2014: a retrospective cohort study. BMJ Open 2020; 10: e033576
• 4 Bodger K, Bowering K, Sarkar S. et al. All-cause mortality after first ERCP in England: clinically guided analysis of hospital episode statistics with linkage to registry of death. Gastrointest Endosc 2011; 74: 825-833
• 5 Harvey PR, Baldwin S, Mytton J. et al. Higher volume providers are associated with improved outcomes following ERCP for the palliation of malignant biliary obstruction. EClinicalMedicine 2020; 18: 100212
• 6 Müller PC, Hodson J, Kuemmerli C. et al. Effect of time to surgery in resectable pancreatic cancer: a systematic review and meta-analysis. Langenbecks Arch Surg 2020; 405: 293-302
• 7 Pande R, Hodson J, Marudanayagam R. et al. Survival advantage of upfront surgery for pancreatic head cancer without preoperative biliary drainage. Front Oncol 2020; 10: 526514
• 8 National Institute for Health and Care Excellence. NICE guideline [NG85] Pancreatic cancer in adults: diagnosis and management. https://www.nice.org.uk/guidance/ng85
• 9 RICHOCET Study group, West Midlands Research Collaborative. Receipt of Curative Resection or Palliative Care for Hepatopancreaticobiliary Tumours (RICOCHET): Protocol for a nationwide collaborative observational study. JMIR Res Protoc 2019; 8
• 10 Harris PA, Taylor R, Thielke R. et al. Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform 2009; 42: 377-381
• 11 Harris PA, Taylor R, Minor BL. et al. The REDCap consortium: Building an international community of software platform partners. J Biomed Inform 2019; 95
• 12 Department of Health. The NHS Cancer plan; a plan for investment, a plan for reform. London, UK: Department of health; 2000.
• 13 Banks PA, Bollen TL, Dervenis C. et al. Classification of acute pancreatitis--2012: revision of the Atlanta classification and definitions by international consensus. Gut 2013; 62: 102-111
• 14 Khwaja A. KDIGO clinical practice guidelines for acute kidney injury. Nephron Clin Pract 2012; 120: c179-c184
• 15 NHS Health Research Authority. Is my study research?. https://www.hra-decisiontools.org.uk/ethics/
• 16 Cotton PB, Garrow DA, Gallagher J. et al. Risk factors for complications after ERCP: a multivariate analysis of 11,497 procedures over 12 years. Gastrointest Endosc 2009; 70: 80-88
• 17 Johnson KD, Perisetti A, Tharian B. et al. Endoscopic retrograde cholangiopancreatography-related complications and their management strategies: A "scoping" literature review. Dig Dis Sci 2020; 65: 361-375
• 18 Cotton PB, Lehman G, Vennes J. et al. Endoscopic sphincterotomy complications and their management: an attempt at consensus. Gastrointest Endosc 1991; 37: 383-393
• 19 Banks PA, Bollen TL, Dervenis C. et al. Classification of acute pancreatitis—2012: revision of the Atlanta classification and definitions by international consensus. Gut 2013; 62: 102-111
• 20 Driver RJ, Handforth C, Radhakrishna G. et al. The Glasgow Prognostic Score at the time of palliative esophageal stent insertion is a predictive factor of 30-day mortality and overall survival. J Clin Gastroenterol 2018; 52: 223-228
• 21 Van der Gaag NA, Rauws EAJ, van Eijck CHJ. et al. Preoperative biliary drainage for cancer of the head of the pancreas. N Engl J Med 2010; 362: 129-137