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Preoperative Biliary Drainage for Cancer of the Head of the Pancreas

Preoperative Biliary Drainage for Cancer of the Head of the Pancreas.

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Preoperative Biliary Drainage for Cancer of the Head of the Pancreas

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  1. Preoperative Biliary Drainage for Cancer of the Head of the Pancreas Niels A. van derGaag, M.D., Erik A.J. Rauws, M.D., Ph.D., Casper H.J. van Eijck, M.D., Ph.D., Marco J. Bruno, M.D., Ph.D., Erwin van derHarst, M.D., Ph.D., Frank J.G.M. Kubben, M.D., Ph.D., Josephus J.G.M. Gerritsen, M.D., Ph.D., Jan Willem Greve, M.D., Ph.D., Michael F. Gerhards, M.D., Ph.D., Ignace H.J.T. de Hingh, M.D., Ph.D., Jean H. Klinkenbijl, M.D., Ph.D., Chung Y. Nio, M.D., Steve M.M. de Castro, M.D., Ph.D., Olivier R.C. Busch, M.D., Ph.D., Thomas M. van Gulik, M.D., Ph.D., Patrick M.M. Bossuyt, Ph.D., and Dirk J. Gouma, M.D., Ph.D.

  2. Introduction • Obstructive jaundice: common problem in patientswith peri-ampullary cancer. • patients who have no radiologic evidence of metastasis: surgicalresection is the only option for cure. • Since surgery inpatients with jaundice is thought to increase the risk of postoperativecomplications, preoperative biliary drainage was introducedto improve the postoperative outcome. • What studies have shown… conflicting results • Pre-op biliarydrainage reduced morbidity and mortality after surgery • Overall complicationrate in patients undergoing pre-op biliary drainage washigher than that in patients who proceeded directly to surgery.

  3. Introduction • Difference in results: complicationsassociated with the pre-op biliary drainage procedureitself. • Pre-op biliary drainage: widely used in the surgical treatment of cancer of the pancreatichead • a multicenter,randomized trial comparing the preoperative procedure followedby surgery with surgery alone.

  4. Objective of the Study • To assess the • rates of seriouscomplications and death • the length of hospital stay associatedwith preoperative biliary drainage

  5. Methods • Patients aged 18-85 yrs who had: • a serumtotal bilirubin level of 2.3to 14.6 mg/dl • no evidence on CT of distant metastasis or local vascular involvement • Endoscopic ultrasonography: performed if CT findings were inconclusive • Exclusion criteria: • with a serious co-existing illness • Karnofsky performancescore, <50 • ongoing cholangitis • previous pre-op biliary drainagewith stenting ERCP or PTC • presence of a serious gastric-outletobstruction (tumor-related duodenal stenosis, which was definedby vomiting and an oral intake of <1 liter per day)

  6. Methods • Informed consent given • Patients were randomly assigned to 2 groups: • endoscopicpre-op biliary drainage for 4-6 wks followed bysurgery • surgery alone within 1 week after diagnosis • Randomization • stratified according to study center • performedw/ a computer program at the coordinating trial center

  7. Study Oversight • Study coordinator collected data at each study site. • Trial: sponsored by the Netherlands Organization for HealthResearch and Development • Did not have access to outcomedata during the trial and did not participate in data analysesor the preparation of the manuscript. • The study coordinator,the clinical epidemiologist, and the lead academic author analyzedthe data and vouch for the completeness and accuracy of theanalyses.

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