Gabriel Rahmi1, Thierry Lecomte2, David Malka3, Thibault Maniere1, Marc Le Rhun4, Rosine Guimbaud5, Marie-Georges Lapalus6, Anne Le Sidaner7, Driffa Moussata8, Olivier Caron9, Jean-Pierre Barbieux10, Marianne Gaudric11, Emmanuel Coron4, Karl Barange12, Thierry Ponchon6, Denis Sautereau7, Elia Samaha13, Jean-Christophe Saurin8, Stanislas Chaussade14, Pierre Laurent-Puig15, Gilles Chatellier16, Christophe Cellier1. 1. 1] Université Paris Descartes, Paris, France; Paris Sorbonne Cité, Paris, France [2] Assistance Publique des Hôpitaux de Paris, Service de Gastroentérologie, Hôpital Européen Georges Pompidou, Paris, France. 2. 1] Université François-Rabelais, Paris, France [2] Service d'Hépato-gastroentérologie et de Cancérologie digestive, CHRU de Tours, Paris, France. 3. Département de Médecine Oncologique, Unité d'oncologie digestive, Institut Gustave Roussy, Villejuif, France. 4. Service d'Hépato-gastroentérologie, CHU de Nantes, Nantes, France. 5. 1] Service d'oncologie, Hôpital Purpan, Toulouse, France [2] Université de Toulouse 3 University, Toulouse, France. 6. Fédération des Spécialités Digestives, Hôpital Edouard Herriot, Lyon, France. 7. Service d'Hépato-gastroentérologie, CHU Dupuytren, Limoges, France. 8. Service de Gastroentérologie, Hôpital Lyon Sud, Lyon, France. 9. Service d'oncogénétique, Institut Gustave Roussy, Villejuif, France. 10. Service d'Hépato-gastroentérologie et de Cancérologie digestive, CHRU de Tours, Paris, France. 11. Assistance Publique des Hôpitaux de Paris, Service de Gastroentérologie, Hôpital Cochin, Paris, France. 12. Service d'Hépato-gastroentérologie, Hôpital Purpan, Toulouse, France. 13. Assistance Publique des Hôpitaux de Paris, Service de Gastroentérologie, Hôpital Européen Georges Pompidou, Paris, France. 14. 1] Université Paris Descartes, Paris, France; Paris Sorbonne Cité, Paris, France [2] Assistance Publique des Hôpitaux de Paris, Service de Gastroentérologie, Hôpital Cochin, Paris, France. 15. 1] Université Paris Descartes, Paris, France; Paris Sorbonne Cité, Paris, France [2] Assistance Publique des Hôpitaux de Paris, Unité d'oncogénétique, Hôpital Européen Georges Pompidou, Paris, France. 16. 1] Université Paris Descartes, Paris, France; Paris Sorbonne Cité, Paris, France [2] Assistance Publique des Hôpitaux de Paris, Unité d'épidémiologie et de recherche clinique, Hôpital européen Georges Pompidou, Paris, France.
Abstract
OBJECTIVES: In Lynch syndrome, flat and diminutive adenomas are particularly prone to malignant transformation, but they can be missed by standard colonoscopy. It is not known whether chromocolonoscopy is able to detect more adenomas than standard colonoscopy in patients with Lynch syndrome. METHODS: We conducted a prospective, multicenter, randomized trial to compare standard colonoscopy with standard colonoscopy followed by pancolonic chromoscopy with indigo carmine in patients with a proven germline mutation in a mismatch-repair gene related to Lynch syndrome and who were undergoing screening or surveillance colonoscopy. Standard colonoscopy was used first to detect visible lesions. Colonoscopy with chromoscopy was then performed by a second gastroenterologist (blinded to the findings of the first colonoscopy) to detect additional lesions. The primary end point was the number of patients in whom at least one adenoma was detected. RESULTS: A total of 78 eligible patients (median age, 45 years) were enrolled at 10 centers from July 2008 to August 2009. Significantly more patients with at least one adenoma were identified by chromocolonoscopy (32/78 (41%)) than by standard colonoscopy (18/78 (23%); P<0.001). The percentage of patients in whom at least one additional adenoma was detected during the chromoscopy was 31% (24/78). Overall, chromocolonoscopy plus colonoscopy detected a total of 55 adenomas in 32 patients (mean number of adenomas detected per patient: 0.7 vs. standard colonoscopy alone: 0.3; P<0.001). CONCLUSION: The results support the proposition that chromocolonoscopy may significantly improve the detection rate of colorectal adenomas in patients undergoing screening or surveillance colonoscopy for Lynch syndrome.
RCT Entities:
OBJECTIVES: In Lynch syndrome, flat and diminutive adenomas are particularly prone to malignant transformation, but they can be missed by standard colonoscopy. It is not known whether chromocolonoscopy is able to detect more adenomas than standard colonoscopy in patients with Lynch syndrome. METHODS: We conducted a prospective, multicenter, randomized trial to compare standard colonoscopy with standard colonoscopy followed by pancolonic chromoscopy with indigo carmine in patients with a proven germline mutation in a mismatch-repair gene related to Lynch syndrome and who were undergoing screening or surveillance colonoscopy. Standard colonoscopy was used first to detect visible lesions. Colonoscopy with chromoscopy was then performed by a second gastroenterologist (blinded to the findings of the first colonoscopy) to detect additional lesions. The primary end point was the number of patients in whom at least one adenoma was detected. RESULTS: A total of 78 eligible patients (median age, 45 years) were enrolled at 10 centers from July 2008 to August 2009. Significantly more patients with at least one adenoma were identified by chromocolonoscopy (32/78 (41%)) than by standard colonoscopy (18/78 (23%); P<0.001). The percentage of patients in whom at least one additional adenoma was detected during the chromoscopy was 31% (24/78). Overall, chromocolonoscopy plus colonoscopy detected a total of 55 adenomas in 32 patients (mean number of adenomas detected per patient: 0.7 vs. standard colonoscopy alone: 0.3; P<0.001). CONCLUSION: The results support the proposition that chromocolonoscopy may significantly improve the detection rate of colorectal adenomas in patients undergoing screening or surveillance colonoscopy for Lynch syndrome.
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