Frederic Prat1, Sarah Leblanc1, Frantz Foissac2, Thierry Ponchon3, René Laugier4, Philippe Bichard5,6, Frédérique Maire7, Dimitri Coumaros8, Antoine Charachon9, Bruno Vedrenne10, Isabelle Boytchev11, Stanislas Chaussade12, Nadira Kaddour13, Arthur Laquière14, Sèbastien Gaujoux15. 1. Department of Gastroenterology, Assistance Publique Hopitaux de Paris, Paris-Descartes University, Paris, France. 2. Clinical Research Unit, Cochin Hospital, Paris, France. 3. Gastroenterology, Hopital Edouard Herriot, Lyon, France. 4. Gastroenterology, Assistance Publique Hopitaux de Marseille, Marseille, France. 5. Digestive Endoscopy Unit, Centre Hospitalier Universitaire de Grenoble, Grenoble, France. 6. Service de Gastro-entérologie et Hépatologie, Hopitaux Universitaires de Geneve, Geneva, Switzerland. 7. Gastroenterology, Hopital Beaujon, Clichy, France. 8. IRCAD/EITS, University Hospital, Strasbourg, France. 9. Endoscopy, Fondation Princesse Grace de Monaco, Monaco, Monaco. 10. Groupe Hospitalier de la Region de Mulhouse et Sud Alsace, Mulhouse, France. 11. Hopital Bicetre, Le Kremlin-Bicetre, France. 12. Gastroenterology, Assistance Publique Hopitaux de Paris, Paris, France. 13. Clinical Research Unit, Hopital Cochin, Paris, France. 14. Gastroenterology and Endoscopy Unit, Hopital st joseph, Marseille, France. 15. Department of Surgery, Assistance Publique - Hopitaux de Paris, Paris, France.
Abstract
BACKGROUND AND AIMS: Single-operator cholangioscopy (SOC) can help diagnose biliopancreatic conditions. The impact of SOC on patient outcome has never been specifically addressed. PATIENTS AND METHODS: Consecutive patients bearing indeterminate biliary strictures (IDBS), or primary sclerosing cholangitis (PSC) with suspected cholangiocarcinoma, were included. Patients with IDBS had at least one previous inconclusive endoscopic retrograde cholangio pancreatography (ERCP) + cytology. Primary endpoint was the difference in adequacy of management planned before and after SOC with regard to final diagnosis obtained after surgery or 24 months follow-up. DESIGN: Prospective open-label multicentre trial. RESULTS: 61 patients were included (IDBS: 48; PSC: 13); 70.5% had a benign lesion (IDBS 66.7%, PSC 84.6%). The management adequacy rate was significantly higher after SOC than before SOC overall (p<10-5), in IDBS (p<0.001) and PSC (p<0.05) patients. SOC induced changes in the management of the majority of patients in all groups (60.3%). The overall sensitivity of combined visual impression and biopsy ranged from 52% to 63.6% depending on investigator or independent expert rating (κ 0.92-0.96), whereas specificity, positive and negative predictive values of SOC were, respectively, 100%, 100% and 83.6%. Patient management observed at the end of follow-up was consistent with that anticipated after SOC in 88.5% overall. CONCLUSION: Despite a moderate sensitivity for the diagnosis of malignancy, SOC has a dramatic impact on the management of patients with IDBS and PSC with suspected carcinoma. Cholangioscopy might be implemented in the workup of selected patients with challenging diagnosis, when a significant impact on outcome (essentially resection vs conservative management) is to be expected.
BACKGROUND AND AIMS: Single-operator cholangioscopy (SOC) can help diagnose biliopancreatic conditions. The impact of SOC on patient outcome has never been specifically addressed. PATIENTS AND METHODS: Consecutive patients bearing indeterminate biliary strictures (IDBS), or primary sclerosing cholangitis (PSC) with suspected cholangiocarcinoma, were included. Patients with IDBS had at least one previous inconclusive endoscopic retrograde cholangio pancreatography (ERCP) + cytology. Primary endpoint was the difference in adequacy of management planned before and after SOC with regard to final diagnosis obtained after surgery or 24 months follow-up. DESIGN: Prospective open-label multicentre trial. RESULTS: 61 patients were included (IDBS: 48; PSC: 13); 70.5% had a benign lesion (IDBS 66.7%, PSC 84.6%). The management adequacy rate was significantly higher after SOC than before SOC overall (p<10-5), in IDBS (p<0.001) and PSC (p<0.05) patients. SOC induced changes in the management of the majority of patients in all groups (60.3%). The overall sensitivity of combined visual impression and biopsy ranged from 52% to 63.6% depending on investigator or independent expert rating (κ 0.92-0.96), whereas specificity, positive and negative predictive values of SOC were, respectively, 100%, 100% and 83.6%. Patient management observed at the end of follow-up was consistent with that anticipated after SOC in 88.5% overall. CONCLUSION: Despite a moderate sensitivity for the diagnosis of malignancy, SOC has a dramatic impact on the management of patients with IDBS and PSC with suspected carcinoma. Cholangioscopy might be implemented in the workup of selected patients with challenging diagnosis, when a significant impact on outcome (essentially resection vs conservative management) is to be expected.
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