708 Simplifying Radiofrequency Ablation of Barrett's Esophagus: a Randomized Multicenter Trial Comparing Three Different Treatment Regimens for Circumferential Ablation Using the HALO 360 System

708 Simplifying Radiofrequency Ablation of Barrett's Esophagus: a Randomized Multicenter Trial Comparing Three Different Treatment Regimens for Circumferential Ablation Using the HALO 360 System

Abstracts 667 Routine Follow-up Biopsies to Detect Local Recurrence After Complete Endoscopic Resection for Early Gastric Cancer May Be Unnecessary J...

76KB Sizes 1 Downloads 27 Views

Abstracts

667 Routine Follow-up Biopsies to Detect Local Recurrence After Complete Endoscopic Resection for Early Gastric Cancer May Be Unnecessary Jong Yeul Lee*, IL Ju Choi, Soo-Jeong Cho, Chan Gyoo Kim, Myeong-Cherl Kook, Jun Ho Lee, Keun Won Ryu, Young-Woo Kim Center for Gastric Cancer, National Cancer Center, Goyang-si, Gyeonggi-do, Republic of Korea Background and study aims: Local recurrence due to residual tumor may occur at the endoscopic resection (ER) site after ER for early gastric cancer (EGC). The aims of this study were to evaluate the predictive factors for local recurrence and suggest an appropriate follow-up biopsy strategy. Patients and methods: We retrospectively reviewed 396 EGCs from 372 consecutive patients who underwent ER between January 2002 and April 2008. Cumulative recurrence rate were determined by the Kaplan-Meier method and Cox proportional hazards analysis was used to determine the risk factors for local recurrence. Results: Local recurrence at ER site was found in 17 cases among 396 lesions during a median follow-up period of 48 months. The 5-year cumulative local recurrence rate was 4.8%. Multivariate analyses determined that tumor involvement at the lateral resection margin [hazard ratio (HR): 35.9; P⬍ 0.001], an uncheckable lateral resection margin [HR: 16.8; P⬍ 0.001], an uncheckable or involved deep resection margin [HR: 3.76; P⫽ 0.047], and a piecemeal resection [HR: 3.95; P⫽ 0.007] were associated with local recurrence. If a lesion was positive for any of these risk factors, the 5-year cumulative recurrence rate was 27.0%, while local recurrence was not found in any lesion that lacked these risk factors. Most episodes of recurrence were found during the first or second follow-up endoscopic biopsy at the ulcer scar. Conclusions: Routine follow-up biopsies at the ER site might be unnecessary in cases where an EGC lesion was endoscopically resected en bloc with tumor-free lateral and deep margins.

708 Simplifying Radiofrequency Ablation of Barrett’s Esophagus: a Randomized Multicenter Trial Comparing Three Different Treatment Regimens for Circumferential Ablation Using the HALO 360 System Frederike G. Van Vilsteren*1, Lorenza Alvarez Herrero2, Roos E. Pouw1, Kai Yi N. Phoa1, Carine Sondermeijer1, Gesina Van Lijnschoten3, Cees A. Seldenrijk4, Mike Visser5, Mark I. Van Berge Henegouwen6, Bas L. Weusten2, Erik J. Schoon7, Jacques J. Bergman1 1 Gastroenterology, Academic Medical Center, Amsterdam, Netherlands; 2 Gastroenterology, St Antonius Hospital, Nieuwegein, Netherlands; 3 Pathology, Catharina Hospital, Eindhoven, Netherlands; 4Pathology, St Antonius Hospital, Nieuwegein, Netherlands; 5Pathology, Academic Medical Center, Amsterdam, Netherlands; 6Surgery, Academic Medical Center, Amsterdam, Netherlands; 7Gastroenterology, Catharina Hospital, Eindhoven, Netherlands Background: Radiofrequency ablation (RFA) is safe and effective for the endoscopic removal of neoplastic Barrett’s esophagus (BE). The current regimen of circumferential balloon-based RFA (c-RFA) is consists of two ablation passes with an intervening cleaning step to remove debris from the ablation zone and electrode. A simplified regimen may be of clinical utility, if it were easier and faster, yet equally safe and efficacious. Aims: To compare the safety and efficacy of three c-RFA ablation regimens. Methods: In 3 centers, consecutive BE patients scheduled for c-RFA for flat-type low-grade or high-grade intraepithelial neoplasia (LGIN/HGIN) or for residual BE after prior endoscopic resection for HGIN/cancer were enrolled. Patients were randomized prior to the sizing procedure. Ablation (c-RFA) was delivered by the HALO360 device (12J/cm2) in all randomized cohorts. Standard: c-RFA, remove device, clean, c-RFA. Simple⫹clean; c-RFA, clean without removing device, c-RFA. Simple-no-clean: 2 applications of c-RFA, no removal of device or cleaning. After c-RFA, patients underwent focal RFA every 2-3 months until achieving complete response for neoplasia and intestinal metaplasia (CR-N; CR-IM). BE regression (%) at 3 months was graded by 2 expert endoscopists, blinded to the allocated regimen, using endoscopic images of every 1-2cm of BE, obtained immediately prior to c-RFA and at 3 months. Primary outcome: BE surface regression at 3 months (mean of 2 expert endoscopists) (calculated sample size 57 patients, non-inferiority defined as⬍20% difference in BE regression). Secondary outcomes: procedure time, introductions, complications. Results: 57 patients (45M, 64⫾15yrs, median BE C3M5) were randomized, 28 had prior ER. Baseline BE length, prior ER, and baseline histology were similar among groups. Overall median BE regression at 3 months for all 3 groups was 83% (IQR61-93): 83% with standard; 78% with simple⫹clean; and 88% with simple-no-clean (Table 1). RFA procedure time was 20 min (IQR18-25) using standard vs 13 min (IQR11-15) using simple⫹clean vs 5 min (IQR5-9) using simple-no-clean (p⬍0.01). Median number of introductions (RFA devices/endoscope) using standard was 7 vs 4 in both simplified regimens (p⬍0.01). Four minor complications occurred: 2 lacerations during sizing, 1 hospitalization for pain, 1 stenosis resolving upon 1 dilation (pre-existing

www.giejournal.org

esophageal narrowing) (Table 1). CR-N and CR-IM were achieved in 42/43 (98%) and 37/43 (86%) of patients that finished treatment by Nov ’11. There were no differences in CR-N, CR-IM, number of treatment sessions or length of treatment period among groups. Conclusions: This randomized study suggests that the current regimen used for c-RFA could be made to be easier and faster, without sacrificing safety or efficacy, by omitting or simplifying the cleaning phase in between ablations. Table 1. standard (nⴝ19) Primary outcome BE surface BE surface regression at 3 months (median, IQR) Secondary outcome Procedure time (min, IQR) Introductions (median, IQR) Treatment outcomes CR-neoplasia CR-IM RFA sessions (median, IQR) RFA treatment period (median months, IQR) Complications

simpleⴙclean (nⴝ19)

simple-noclean (nⴝ18)

P

83% (70– 93)

78% (55– 88)

88% (79–97)

0.14

20 (18–25) 7 (7–7)

13 (11–15) 4 (4–4)

5 (5–9) 4 (4–5)

⬍0.01 ⬍0.01

94% (16/17 pts) 88% (15/17 pts) 2 (2–3) 7 (6–10)

93% (14/15 pts) 87% (13/15 pts) 2 (2–3) 8 (3–10)

100% (13/13 pts) 85% (11/13 pts) 2 (2–3) 3 (3–6)

0.66

0.38 0.10

1⌿

0

3␭

0.16

0.96

BE⫽Barrett’s esophagus, IQR⫽ interquartile range, CR⫽ complete response, IM⫽intestinal metaplasia, RFA⫽radiofrequency ablation, ⌿⫽laceration, ␭⫽stenosis; laceration; hospitalization.

709 A Prospective Multicenter Study to Identify Predictive Markers for Initial Treatment Response After Circumferential Radiofrequency Ablation for Barrett’s Esophagus With Early Neoplasia Frederike G. Van Vilsteren*1, Lorenza Alvarez Herrero2, Roos E. Pouw1, Dennis Schrijnders1, Carine Sondermeijer1, Raf Bisschops3, Jose Miguel Esteban Lopez-Jamar4, Alexander Meining5, Horst Neuhaus6, Adolfo Parra-Blanco7, Oliver Pech8, Krish Ragunath9, Bjorn Rembacken10, Ed Schenk11, Mike Visser12, Fiebo J. Ten Kate12, Johannes B. Reitsma13, Bas L. Weusten2, Erik J. Schoon14, Jacques J. Bergman1 1 Gastroenterology, Academic Medical Center, Amsterdam, Netherlands; 2 Gastroenterology, St Antonius Hospital, Nieuwegein, Netherlands; 3 Gastroenterology, University Hospital Gasthuisberg, Leuven, Belgium; 4 Gastroenterology, Hospital Clínico San Carlos, Madrid, Spain; 5 Gastroenterology, Klinikum Rechts der Isar, München, Germany; 6 Gastroenterology, Evangelisches Krankenhaus, Düsseldorf, Germany; 7 Gastroenterology, Hospital Universitario Central de Asturias, Oviedo, Spain; 8Gastroenterology, Dr.-Horst-Schmidt-Kliniken, Wiesbaden, Germany; 9Gastroenterology, Queens Medical Centre, Nottingham, United Kingdom; 10Gastroenterology, Nuffield Hospital, Leeds, United Kingdom; 11Gastroenterology, Isala Clinics, Zwolle, Netherlands; 12 Pathology, Academic Medical Center, Amsterdam, Netherlands; 13 Clinical Epidemiology and Biostatistics, Academic Medical Center, Amsterdam, Netherlands; 14Gastroenterology, Catharina Hospital, Eindhoven, Netherlands Background: Endoscopic radiofrequency ablation (RFA) is safe and effective for eradication of neoplastic Barrett’s esophagus (BE). In a minority of cases, however, patients demonstrate minimal regression of the BE epithelium at 3 months after initial circumferential balloon-based RFA (c-RFA). Predicting which patients may have poor response at 3 months may be important for clinical decision-making, therefore, baseline predictive factors for poor response at 3 months should be identified. Aims: To identify predictive factors for poor response at 3 months to c-RFA, and to relate 3 month BE regression to c-RFA to final treatment outcome. Methods: We included consecutive patients from 12 centers who underwent c-RFA for primary eradication of flat high-grade intraepithelial neoplasia (HGIN) or for removal of residual BE after endoscopic resection (ER) of HGIN/cancer. 72 factors relating to patient characteristics and treatment were registered prospectively. The % BE surface regression at 3 mo was scored independently by 2 expert endoscopists (blinded to clinical information) using endoscopic images prior to c-RFA and at 3 mo after c-RFA. Logistic regression analysis was performed using a cut-off value of BE regression ⬍50% at 3 mo (’poor initial response’). Results: A total of 284 patients were

Volume 75, No. 4S : 2012

GASTROINTESTINAL ENDOSCOPY

AB158