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Endoscopic Full-Thickness Plication for GERD: 6-Month Follow-Up to a Multi-Center Sham-Controlled Trial
Abstracts
557 Cost Effectiveness of String Capsule Endoscopy for Screening and Surveillance of Esophageal Varices Sally Stipho, Ananya Das, Virender K. Sharma, Francisco C. Ramirez Current guidelines recommend endoscopic screening and surveillance for varices in patients with cirrhosis. Both screening and surveillance are primarily done with EGD but capsule endoscopy is emerging as a novel and less invasive endoscopic modality. String capsule endoscopy (SCE) allows multiple uses after high-grade disinfection but its cost-effectiveness has not been tested. Aim: To compare the cost-effectiveness of SCE, PillCam Eso (PCE) with EGD for screening and surveillance of esophageal varices. Methods: A Markov model with a third party payer’s perspective was built to compare 4 strategies of screening for varices and subsequent management in a hypothetical cohort of 50 year old patients with compensated cirrhosis, over a time horizon of 10 years. In strategy I, no screening was performed and natural history of compensated cirrhosis was modeled. In strategy II, III and IV, EGD, PCE and SCE, respectively were used for screening for varices. In the last three strategies, primary prophylaxis against variceal bleeding using beta blockers was administered in patients with clinically significant varices. The performance characteristics of SCE, was obtained from our prior experience; similar values were used for PCE. EGD was considered gold standard. Clinical probabilities (probability of developing varices, risk of variceal bleeding and risk reduction in bleeding by beta blockade, etc.) was obtained from published data. Liver transplantation was not considered in this model. Costs were estimated from Medicare reimbursement data, all costs were adjusted to 2006 US dollars. Both cost and quality adjusted life years (QALY) were discounted. Results: The results of the baseline analysis are shown in Table. The strategy of no screening was dominated by all other strategies. The PCE-based strategy was dominated by the SCE-based strategy because it was more expensive but without incremental effectiveness. The strategy based on EGD was most expensive but yielded the highest QALY at an incremental cost-effectiveness of $17,527. EGD-based strategy provided incremental net health benefit over SCE-based strategy only with a willingness to pay above $34,000. Sensitivity analysis, within the range used in this analysis, did not change the results. Conclusions: SCE is cost-effective in screening for esophageal varices in patients with compensated cirrhosis and, compared to EGD, is less expensive. Baseline analysis Strategy
Cost
QALY
ICER (Incremental Cost-Effectiveness Ratio)
I: No screening II: EGD III: SCE IV: PCE
9772 9062 8883 8948
6.121 6.218 6.207 6.207
DOMINATED by all strategy 17,527
Purpose: Esophageal varices (EV) are a serious consequence of portal hypertension (PHT), associated with a mortality rate of bleeding 20% or more. Current guidelines recommend endoscopic screening of patients with cirrhosis and therapy based on these findings. Several pilot studies including our own (Eisen et al, Endoscopy 2006) suggest that PillCam ESO compares favorably with the diagnostic yield of upper endoscopy (EGD). This multi-center (14) trial was performed to validate these preliminary findings. Methods: Patients who were undergoing clinically indicated EGD for screening or surveillance of EV were asked to undergo a PillCam ESO study prior to the EGD. EGD was performed within 48 hrs of PillCam ESO study. The endoscopist was not blinded to patient history/findings. A second investigator read each PillCam ESO study, blinded to patient history and EGD results. Results: 285 patients underwent PillCam ESO and EGD. One patient was excluded because of vomiting the capsule prior to video capture of the distal esophagus. In another case, the capsule remained in the esophagus near the Z-line for about 25 minutes due to a stricture that was demonstrated in the video. Since the patient had nausea the capsule was safely removed by the following EGD. There were no other complications or capsule retention in this study. 61.4% of patients underwent the procedures for screening purposes, the remainder for surveillance of known EV. Sensitivity, specificity, PPV, and NPV for PillCam ESO as compared to EGD were 86.7%, 88.4%, 92.9%, 79.1%, respectively. Overall agreement was 87.3% (CI 83-91%) Kappa score was 0.733. There was complete agreement on Varices grade in 232/284 (82%) of cases. In 3 cases, PillCam ESO did not detect EV that were considered medium/large on EGD. EGD did not detect 1 case of medium EV as seen by PillCam ESO. In differentiating between two patients’ management alternatives (i.e. large varices which requires treatment and small varices or no varices which requires monitoring) sensitivity, specificity, PPV, and NPV for PillCam ESO as compared to EGD were 84.6%, 96.1%, 89.2%, 94.3%, respectively. The overall agreement on treatment decisions based on EV size was 93%. Conclusions: PillCam ESO is a safe, well tolerated, and noninvasive method for detecting EV. Test characteristics appear comparable to EGD in this, the largest trial to date. We believe that this device should now be considered an alternative to EGD for both screening for EV as well as potentially for surveillance in patients who have had prior EV obliteration.
DOMINATED by strategy III
558 Endoscopic Full-Thickness Plication for GERD: 6-Month Follow-Up to a Multi-Center Sham-Controlled Trial Richard I. Rothstein, Charles J. Filipi, Karel Caca, Ronald E. Pruitt, Klaus Mergener, Alfonso Torquati, Gregory B. Haber, Kenneth Chang, David Wong, Jacques M. Deviere, Douglas K. Pleskow, Charles J. Lightdale, Alain Ades, Richard A. Kozarek, William O. Richards, Anthony J. Lembo Background: The endoscopic full-thickness PlicatorÔ (NDO Surgical, Mansfield MA) delivers a transmural suture at the gastroesophageal junction to restructure the gastric cardia. The resulting tissue plication is intended to accentuate the valvular mechanism of the gastroesophageal junction. Aim: To evaluate the safety and efficacy of the Plicator procedure for the treatment of symptomatic GERD in a cohort of patients followed out from their original participation in a shamcontrolled study. Methods: Patients with chronic heartburn and pathologic reflux requiring daily proton pump inhibitor (PPI) therapy were enrolled. Excluded from treatment were patients with esophageal dysmotility, esophagitis grade III or IV (Savary-Miller), Barrett’s epithelium, and hiatus hernia O2 cm. All patients received a single, endoscopically placed full-thickness plication in the anterior gastric cardia. The primary study endpoint was R50% improvement in GERD health-related quality of life (HRQL) score. Secondary end points included VAS, SF-36, GERD medication use, and esophageal acid exposure. Results: A total of 148 patients were treated at 14 study sites. No re-treatments were performed. Six-months postplication, 64/106 patients (60%) had improved their GERD-HRQL score by at least 50%. Median percent change in GERD-HRQL score, VAS score, and SF-36 composite scores were all significantly improved compared to off meds baseline values. The need for daily PPI therapy was eliminated in 57% of patients at 6-months posttreatment with an additional 19% of patients able to reduce their PPI dose by at least half. Esophageal pH normalization was achieved in 23% of patients. There were no perforations, deaths or late onset adverse events. Common postprocedure events were abdominal pain (24%), chest pain (16%), shoulder pain (8%) and back pain (4%). Conclusions: At 6 months post-procedure, the cohort originally treated with full-thickness plication with the Plicator and the cross-over group treated after sham showed the endoscopic treatment to be safe and effective in reducing GERD symptoms and medication use.
www.giejournal.org
559 Esophageal Capsule Endoscopy (PillCam ESO) Is Comparable to Traditional Endoscopy for Detection of Esophageal Varices-An International Multi-Center Trial Roberto De Franchis, Glenn M. Eisen, Abraham R. Eliakim, Amandeep Sahota, Ignacio Fernandez-Urien, Juan M. Herrerias, Jay L. Goldstein, John J. Vargo, Hugo E. Vargas, Laurel Fisher
560 Endoscopic Treatment of Esophageal Varices in Cirrhotic Patients: Band Ligation Versus Cyanoacrylate Injection Marcus M. Santos, Rodrigo Azevedo Rodrigues, Luciano Lenz, Frank Nakao, Maria Rachel S. Rohr, Mario Kondo, Angelo P. Ferrari, Ermelindo D. Libera Background: Coagulation disorders in Child-Pugh C patients lead to poor results of endoscopic sclerotherapy and band ligation. Although controversial, the injection of cyanoacrylate has been successfully used for variceal bleeding management. There are no studies comparing endoscopic band ligation (EBL) and cyanoacrylate injection (CI) for esophageal variceal management in this group of patients. Aims: To compare effectiveness, mortality, and complications related to CI and EBL in cirrhotic patients with severe liver disease. Patients and Methods: From November 2004 to September 2006, 38 consecutive patients Child-Pugh R 8, with medium or large esophageal varices (EV) with red spots were included for primary or secondary prophylaxis. Patients were randomized into 2 groups, EBL (n Z 20), in a three-week interval basis or CI (n Z 18) with a mixture of 0.5 ml of cyanoacrylate and lipiodol (1:1) in a two week interval basis, with a second injection in each vessel if necessary. Small varices were treated with sclerotherapy. Radiographic control was made after CI. This study was approved by the local Institutional Review Board. Results: The groups were similar in demographics characteristics, cirrhosis etiology, liver function, previous variceal bleeding, beta-blocker use and EV characteristics. The patients were followed by 298 (163) and 235 (113) days in the EBL and CI groups respectively. Effectiveness was similar in the groups, with a variceal eradication rate of 90% in EBL group and 80% in CI group, with respectively 3.17 (1.15) and 3 (1.36) sessions on average. Minor complications were significantly higher in the CI group (72% vs. 15% - p Z 0.0007), mainly due to severe transitory retroesternal pain and dysphagia. Major complications were not statistically different in the two groups. In EBL group, 3 patients (15%) had major complications: esophageal stenosis, bleeding during procedure and upper gastrointestinal bleeding of unknown source. In the CI group, 5 patients (28%) had variceal bleeding, esophageal ulcer bleeding and splenic infarction after splenic artery embolization of cyanoacrylate. Also, there was no statistical difference between EBL and CI in mortality rate (40% vs. 39%), bleeding related deaths (5% vs. 22%) or procedure related deaths (0 vs. 11%). The cumulative survival of the groups were not statistically different (p Z 0.6 - log rank test). Conclusions: There were no significant differences between EBL and CI in effectiveness, mortality, and major complications in esophageal varices management of cirrhotic patients with severe impairment of liver function. Minor complications were significantly more common in CI group.
Volume 65, No. 5 : 2007 GASTROINTESTINAL ENDOSCOPY AB107
557 Cost Effectiveness of String Capsule Endoscopy for Screening and Surveillance of Esophageal Varices Sally Stipho, Ananya Das, Virender K. Sharma, Francisco C. Ramirez Current guidelines recommend endoscopic screening and surveillance for varices in patients with cirrhosis. Both screening and surveillance are primarily done with EGD but capsule endoscopy is emerging as a novel and less invasive endoscopic modality. String capsule endoscopy (SCE) allows multiple uses after high-grade disinfection but its cost-effectiveness has not been tested. Aim: To compare the cost-effectiveness of SCE, PillCam Eso (PCE) with EGD for screening and surveillance of esophageal varices. Methods: A Markov model with a third party payer’s perspective was built to compare 4 strategies of screening for varices and subsequent management in a hypothetical cohort of 50 year old patients with compensated cirrhosis, over a time horizon of 10 years. In strategy I, no screening was performed and natural history of compensated cirrhosis was modeled. In strategy II, III and IV, EGD, PCE and SCE, respectively were used for screening for varices. In the last three strategies, primary prophylaxis against variceal bleeding using beta blockers was administered in patients with clinically significant varices. The performance characteristics of SCE, was obtained from our prior experience; similar values were used for PCE. EGD was considered gold standard. Clinical probabilities (probability of developing varices, risk of variceal bleeding and risk reduction in bleeding by beta blockade, etc.) was obtained from published data. Liver transplantation was not considered in this model. Costs were estimated from Medicare reimbursement data, all costs were adjusted to 2006 US dollars. Both cost and quality adjusted life years (QALY) were discounted. Results: The results of the baseline analysis are shown in Table. The strategy of no screening was dominated by all other strategies. The PCE-based strategy was dominated by the SCE-based strategy because it was more expensive but without incremental effectiveness. The strategy based on EGD was most expensive but yielded the highest QALY at an incremental cost-effectiveness of $17,527. EGD-based strategy provided incremental net health benefit over SCE-based strategy only with a willingness to pay above $34,000. Sensitivity analysis, within the range used in this analysis, did not change the results. Conclusions: SCE is cost-effective in screening for esophageal varices in patients with compensated cirrhosis and, compared to EGD, is less expensive. Baseline analysis Strategy
Cost
QALY
ICER (Incremental Cost-Effectiveness Ratio)
I: No screening II: EGD III: SCE IV: PCE
9772 9062 8883 8948
6.121 6.218 6.207 6.207
DOMINATED by all strategy 17,527
Purpose: Esophageal varices (EV) are a serious consequence of portal hypertension (PHT), associated with a mortality rate of bleeding 20% or more. Current guidelines recommend endoscopic screening of patients with cirrhosis and therapy based on these findings. Several pilot studies including our own (Eisen et al, Endoscopy 2006) suggest that PillCam ESO compares favorably with the diagnostic yield of upper endoscopy (EGD). This multi-center (14) trial was performed to validate these preliminary findings. Methods: Patients who were undergoing clinically indicated EGD for screening or surveillance of EV were asked to undergo a PillCam ESO study prior to the EGD. EGD was performed within 48 hrs of PillCam ESO study. The endoscopist was not blinded to patient history/findings. A second investigator read each PillCam ESO study, blinded to patient history and EGD results. Results: 285 patients underwent PillCam ESO and EGD. One patient was excluded because of vomiting the capsule prior to video capture of the distal esophagus. In another case, the capsule remained in the esophagus near the Z-line for about 25 minutes due to a stricture that was demonstrated in the video. Since the patient had nausea the capsule was safely removed by the following EGD. There were no other complications or capsule retention in this study. 61.4% of patients underwent the procedures for screening purposes, the remainder for surveillance of known EV. Sensitivity, specificity, PPV, and NPV for PillCam ESO as compared to EGD were 86.7%, 88.4%, 92.9%, 79.1%, respectively. Overall agreement was 87.3% (CI 83-91%) Kappa score was 0.733. There was complete agreement on Varices grade in 232/284 (82%) of cases. In 3 cases, PillCam ESO did not detect EV that were considered medium/large on EGD. EGD did not detect 1 case of medium EV as seen by PillCam ESO. In differentiating between two patients’ management alternatives (i.e. large varices which requires treatment and small varices or no varices which requires monitoring) sensitivity, specificity, PPV, and NPV for PillCam ESO as compared to EGD were 84.6%, 96.1%, 89.2%, 94.3%, respectively. The overall agreement on treatment decisions based on EV size was 93%. Conclusions: PillCam ESO is a safe, well tolerated, and noninvasive method for detecting EV. Test characteristics appear comparable to EGD in this, the largest trial to date. We believe that this device should now be considered an alternative to EGD for both screening for EV as well as potentially for surveillance in patients who have had prior EV obliteration.
DOMINATED by strategy III
558 Endoscopic Full-Thickness Plication for GERD: 6-Month Follow-Up to a Multi-Center Sham-Controlled Trial Richard I. Rothstein, Charles J. Filipi, Karel Caca, Ronald E. Pruitt, Klaus Mergener, Alfonso Torquati, Gregory B. Haber, Kenneth Chang, David Wong, Jacques M. Deviere, Douglas K. Pleskow, Charles J. Lightdale, Alain Ades, Richard A. Kozarek, William O. Richards, Anthony J. Lembo Background: The endoscopic full-thickness PlicatorÔ (NDO Surgical, Mansfield MA) delivers a transmural suture at the gastroesophageal junction to restructure the gastric cardia. The resulting tissue plication is intended to accentuate the valvular mechanism of the gastroesophageal junction. Aim: To evaluate the safety and efficacy of the Plicator procedure for the treatment of symptomatic GERD in a cohort of patients followed out from their original participation in a shamcontrolled study. Methods: Patients with chronic heartburn and pathologic reflux requiring daily proton pump inhibitor (PPI) therapy were enrolled. Excluded from treatment were patients with esophageal dysmotility, esophagitis grade III or IV (Savary-Miller), Barrett’s epithelium, and hiatus hernia O2 cm. All patients received a single, endoscopically placed full-thickness plication in the anterior gastric cardia. The primary study endpoint was R50% improvement in GERD health-related quality of life (HRQL) score. Secondary end points included VAS, SF-36, GERD medication use, and esophageal acid exposure. Results: A total of 148 patients were treated at 14 study sites. No re-treatments were performed. Six-months postplication, 64/106 patients (60%) had improved their GERD-HRQL score by at least 50%. Median percent change in GERD-HRQL score, VAS score, and SF-36 composite scores were all significantly improved compared to off meds baseline values. The need for daily PPI therapy was eliminated in 57% of patients at 6-months posttreatment with an additional 19% of patients able to reduce their PPI dose by at least half. Esophageal pH normalization was achieved in 23% of patients. There were no perforations, deaths or late onset adverse events. Common postprocedure events were abdominal pain (24%), chest pain (16%), shoulder pain (8%) and back pain (4%). Conclusions: At 6 months post-procedure, the cohort originally treated with full-thickness plication with the Plicator and the cross-over group treated after sham showed the endoscopic treatment to be safe and effective in reducing GERD symptoms and medication use.
www.giejournal.org
559 Esophageal Capsule Endoscopy (PillCam ESO) Is Comparable to Traditional Endoscopy for Detection of Esophageal Varices-An International Multi-Center Trial Roberto De Franchis, Glenn M. Eisen, Abraham R. Eliakim, Amandeep Sahota, Ignacio Fernandez-Urien, Juan M. Herrerias, Jay L. Goldstein, John J. Vargo, Hugo E. Vargas, Laurel Fisher
560 Endoscopic Treatment of Esophageal Varices in Cirrhotic Patients: Band Ligation Versus Cyanoacrylate Injection Marcus M. Santos, Rodrigo Azevedo Rodrigues, Luciano Lenz, Frank Nakao, Maria Rachel S. Rohr, Mario Kondo, Angelo P. Ferrari, Ermelindo D. Libera Background: Coagulation disorders in Child-Pugh C patients lead to poor results of endoscopic sclerotherapy and band ligation. Although controversial, the injection of cyanoacrylate has been successfully used for variceal bleeding management. There are no studies comparing endoscopic band ligation (EBL) and cyanoacrylate injection (CI) for esophageal variceal management in this group of patients. Aims: To compare effectiveness, mortality, and complications related to CI and EBL in cirrhotic patients with severe liver disease. Patients and Methods: From November 2004 to September 2006, 38 consecutive patients Child-Pugh R 8, with medium or large esophageal varices (EV) with red spots were included for primary or secondary prophylaxis. Patients were randomized into 2 groups, EBL (n Z 20), in a three-week interval basis or CI (n Z 18) with a mixture of 0.5 ml of cyanoacrylate and lipiodol (1:1) in a two week interval basis, with a second injection in each vessel if necessary. Small varices were treated with sclerotherapy. Radiographic control was made after CI. This study was approved by the local Institutional Review Board. Results: The groups were similar in demographics characteristics, cirrhosis etiology, liver function, previous variceal bleeding, beta-blocker use and EV characteristics. The patients were followed by 298 (163) and 235 (113) days in the EBL and CI groups respectively. Effectiveness was similar in the groups, with a variceal eradication rate of 90% in EBL group and 80% in CI group, with respectively 3.17 (1.15) and 3 (1.36) sessions on average. Minor complications were significantly higher in the CI group (72% vs. 15% - p Z 0.0007), mainly due to severe transitory retroesternal pain and dysphagia. Major complications were not statistically different in the two groups. In EBL group, 3 patients (15%) had major complications: esophageal stenosis, bleeding during procedure and upper gastrointestinal bleeding of unknown source. In the CI group, 5 patients (28%) had variceal bleeding, esophageal ulcer bleeding and splenic infarction after splenic artery embolization of cyanoacrylate. Also, there was no statistical difference between EBL and CI in mortality rate (40% vs. 39%), bleeding related deaths (5% vs. 22%) or procedure related deaths (0 vs. 11%). The cumulative survival of the groups were not statistically different (p Z 0.6 - log rank test). Conclusions: There were no significant differences between EBL and CI in effectiveness, mortality, and major complications in esophageal varices management of cirrhotic patients with severe impairment of liver function. Minor complications were significantly more common in CI group.
Volume 65, No. 5 : 2007 GASTROINTESTINAL ENDOSCOPY AB107