1. Is upper endoscopy indicated in persons with a positive FOBT and a negative colonoscopy in a population-based colorectal cancer screening program ? Bernard DENIS, Philippe PERRIN, Frédéric VAGNE, André PETER, Jean Christophe PFEIFFER, Daniel BATTISTELLI Association pour le Dépistage du Cancer colorectal dans le Haut-Rhin (ADECA 68), Colmar, FRANCE

2. B. Denis - DDW 2005 - Chicago background l assessment of both feasibility and efficiency of a nation wide population- based colorectal cancer (CRC) FOBT screening program l 22 pilot areas

3. B. Denis - DDW 2005 - Chicago background l whether upper endoscopy is necessary… is controversial l few studies, most small sized, retrospective or individual screening l only 2 in mass screening programs which concluded that upper endoscopy was unjustified in asymptomatic persons… but… (Thomas WM Gut 1990; Rasmussen M Scand J Gastroenterol 2002)

4. B. Denis - DDW 2005 - Chicago aim to assess whether upper endoscopy is indicated in persons with a positive FOBT and a negative colonoscopy in a population-based CRC screening program ?

5. B. Denis - DDW 2005 - Chicago methods l pilot population-based colorectal cancer screening program l Haut-Rhin: 0.71 million inhabitants l all average risk residents aged 50-74 y l biennial non rehydrated guaiac FOBT (Hemoccult II) without dietary restriction

6. B. Denis - DDW 2005 - Chicago methods l prospective recording all upper endoscopies performed after positive FOBT and negative colonoscopy l data collection sdetailed history (upper GI symptoms, drugs, documented anemia…) supper abnormal findings schanges in management sadverse events

7. B. Denis - DDW 2005 - Chicago methods l inclusion criteria sResidents aged 50-74 y participating to CRC screening program sPositive FOBT sComplete colonoscopy sNo lower bleeding lesion, CRC or polyp ≥ 1 cm sAt the discretion of the endoscopist sInformed consent

8. B. Denis - DDW 2005 - Chicago methods l exclusion criteria sFOBT completed out of screening program sIncomplete colonoscopy sLower bleeding lesion, CRC or polyp ≥ 1 cm sDocumented upper GI disease sRecent upper endoscopy < 1 year sPatient refusal

9. B. Denis - DDW 2005 - Chicago 185,000 p. 50-74 y invited 15,642 p. excluded 68,777 FOBT completed 2,559 FOBT + 1,705 colonoscopies 703 CRC or polyps > 1 cm 397 polyps < 1 cm 605 normal methods

10. B. Denis - DDW 2005 - Chicago results l ongoing study: April 2005 (19 months) l 366 upper endoscopies / 1002 (36.6%) u 305 (50.4 %) with normal colonoscopy u 61 (15.4 %) with colorectal polyps < 1 cm

11. B. Denis - DDW 2005 - Chicago diagnostic yield l1 pT1 esophageal adenocarcinoma l3 Barrett’s esophagus l33 reflux esophagitis (28 gr. 1 / 5 gr. 2) l2 angiodysplasia l12 gastric polyps l26 erosive gastritis l1 gastric ulcer l5 erosive duodenitis l2 duodenal ulcers l18 Hp positive 80 / 366 (21.9 %) abnormal upper GI findings

12. B. Denis - DDW 2005 - Chicago diagnostic yield age< 6546 (21.5%)> 6534 (22.5%)NS colonoscopynormal61 (20%)polyps19 (31.1%)NS doc. anemiapresent0 (0%)absent58 (20.5%)- aspirinpresent12 (27.9%)absent49 (19.6%)NS NSAIDpresent8 (33.3%)absent53 (19.9%)NS gendermale43 (27.6%)female37 (17.7%)p=0.02 upper symptomspresent29 (37.2%)absent32 (15%)p<0.01

13. B. Denis - DDW 2005 - Chicago clinical impact l1 surgery l1 Argon plasma coagulation l46 PPI l18 antibiotics l4 NSAID discontinuation l3 endoscopic follow-up 50 / 366 (15 %) change in clinical management

14. B. Denis - DDW 2005 - Chicago clinical impact age< 6531 (14.5%)> 6524 (15.8%)NS colonoscopynormal42 (13.8%)polyps13 (21.3%)NS doc. anemiapresent0 (0%)absent41 (14.5%)- aspirinpresent10 (23.3%)absent34 (13.6%)NS NSAIDpresent7 (29.2%)absent37 (13.9%)- gendermale32 (20.5%)female23 (11%)p=0.01 upper symptomspresent20 (25.6%)absent23 (10.8%)p<0.01

15. B. Denis - DDW 2005 - Chicago 213 asymptomatic persons l abnormal findings: 15 % l changes in management: 10.8% l clinically important lesions: 3.3 % s3 erosive gastritis Hp + s3 erosive duodenitis Hp + s1 reflux esophagitis gr. 2 sno cancer sno Barrett’s

16. B. Denis - DDW 2005 - Chicago asymptomatic persons Number needed to screen to detect one clinically important lesion = 30

17. B. Denis - DDW 2005 - Chicago conclusions l upper endoscopy is not justified in asymptomatic persons with a positive FOBT when colonoscopy is normal or yields small polyps in a population-based CRC screening program l upper endoscopy must be performed in patients with relevant upper symptoms

18. B. Denis - DDW 2005 - Chicago future l upper abnormal findings u positive FOBT ? u by chance ? l control group with colorectal cancer or large polyps