Fundoplication Doesn't Diminish Efficacy of Ablation in Barrett's Patients

SAN DIEGO – Radiofrequency ablation was found to be safe and effective in treating Barrett’s esophagus patients, whether or not they had undergone a prior fundoplication, based on results from a multicenter registry study.

"Gastroesophageal reflux causes esophageal mucosal injury and inflammation that may impair healing and squamous re-epithelialization after treatment of Barrett’s esophagus [BE] with radiofrequency ablation [RFA]," Dr. Nicholas J. Shaheen said at the annual Digestive Disease Week.

Photo courtesy Dr. Nicholas J. Shaheen

"It is unclear if fundoplication surgery, as a mechanical barrier to all reflux, improves treatment outcomes of RFA for BE. Similarly, some have postulated that change in the conformation of the hiatus with surgery might make ablation problematic."

Dr. Shaheen, director of the Center for Esophageal Diseases and Swallowing at the University of North Carolina, Chapel Hill, and his associates conducted the largest study of its kind, he said. They evaluated records from the RFA Patient Registry to assess the relationship between prior fundoplication and both efficacy and safety outcomes in patients with BE who were treated with RFA.

The registry comprises 113 community-based and 35 academic-affiliated medical institutions in the United States. "About 75% of these institutions are private practices, so this is an interesting snapshot of RFA as it’s practiced outside of tertiary care centers," Dr. Shaheen said.

All study patients had BE confirmed by endoscopy and histology, and had undergone treatment with RFA. Enrollment commenced in July 2007 and ended in July 2011. Data were gleaned from standard case report forms and included demographics; relevant medical history; histologic grade prior to treatment; endoscopic findings; dates and total number of RFA treatment sessions; and ablation outcomes and complications.

"The vast amount of data is prospective, but less than 15% is retrospective," Dr. Shaheen said. "This is a registry study, so we could not mandate treatment, but a treatment protocol was suggested." Twice-daily use of proton pump inhibitors (PPIs) was recommended to everyone in the study, including those post fundoplication.

The mean age of patients was 61 years, and the majority were white. The mean pretreatment length of BE was about 4 cm, and patients received an average of 2.5 treatments with RFA. "Importantly, in this registry, about half of the patients had nondysplastic disease," Dr. Shaheen said. "Also, roughly 20% in each group had low- and high-grade dysplasia."

Dr. Shaheen reported results from the safety cohort, which included 5,537 patients who received RFA, and results from the efficacy cohort, which included 2,466 patients with biopsies performed 12 months after enrollment. Safety outcomes included perforation, stricture that required dilation, bleeding that required hospitalization or transfusion, and hospitalization. Efficacy outcomes included complete eradication of intestinal metaplasia and dysplasia.

Among patients in the safety cohort, 301 had a prior fundoplication, whereas 5,236 had received medical therapy only. Patients in the fundoplication group had a somewhat lower mean age than those in the medical therapy group (59 vs. 62 years, P = .0002), and were slightly less likely to be African American (0.3% vs. 1.6%, P = .03) or Hispanic (0.7% vs. 2.6%, P = .03). In the fundoplication group, the length of BE was greater (5.0 cm vs. 4.1 cm, P less than .0001), and the prevalence of nondysplastic BE was higher (53% vs. 49%, P = .05).

In addition, fewer patients in the fundoplication group were taking twice-daily PPIs compared with those in the medical therapy group (82% vs. 95%, P less than .001). There were no significant between-group differences in the rates of bleeding, hospitalization, or stricture.

Among patients in the efficacy cohort, 136 had a prior fundoplication and 2,330 had received medical therapy only. The fundoplication patients were slightly younger than the medical therapy patients (59 vs. 62 years, P = .004), had a somewhat greater length of BE (5.0 cm vs. 4.3 cm, P = .009), and were less likely to be taking twice-daily PPIs (75% vs. 93%, P less than .001).

Rates of complete eradication of intestinal metaplasia were 71% in the fundoplication group vs. 73% in the medical therapy group, a nonsignificant difference, while the rate of complete eradication of dysplasia was identical in both groups at 87%.

Among patients who had nondysplastic BE, 75% in the fundoplication group achieved complete eradication of intestinal metaplasia, compared with 81% in the medical therapy group, a nonsignificant difference.

Regarding combined efficacy for dysplastic BE and intramucosal carcinoma, 67% of patients in the fundoplication group achieved complete eradication of intestinal metaplasia, compared with 66% in the medical therapy group, and both groups had a rate of 87% for complete eradication of dysplasia; none of these differences were significant.

Dr. Shaheen acknowledged certain limitations of the study, including the fact that the functional status of the fundoplications was not known. "All we know is that some patients had them," he said. "These are observational data and subject to selection bias. Also note that this is hardly a pure comparison, because the people who got fundoplication were also getting PPIs. However, one might expect that to bias the study in favor of fundoplication, to the degree that the addition of PPIs helps."

The study was funded by Covidien, which provided the RFA equipment used in the study, and by grants from the National Institutes of Health. Dr. Shaheen disclosed that he has consulting relationships with numerous pharmaceutical and medical device companies, but none with Covidien.

SAN DIEGO – Radiofrequency ablation was found to be safe and effective in treating Barrett’s esophagus patients, whether or not they had undergone a prior fundoplication, based on results from a multicenter registry study.

"Gastroesophageal reflux causes esophageal mucosal injury and inflammation that may impair healing and squamous re-epithelialization after treatment of Barrett’s esophagus [BE] with radiofrequency ablation [RFA]," Dr. Nicholas J. Shaheen said at the annual Digestive Disease Week.

Photo courtesy Dr. Nicholas J. Shaheen

"It is unclear if fundoplication surgery, as a mechanical barrier to all reflux, improves treatment outcomes of RFA for BE. Similarly, some have postulated that change in the conformation of the hiatus with surgery might make ablation problematic."

Dr. Shaheen, director of the Center for Esophageal Diseases and Swallowing at the University of North Carolina, Chapel Hill, and his associates conducted the largest study of its kind, he said. They evaluated records from the RFA Patient Registry to assess the relationship between prior fundoplication and both efficacy and safety outcomes in patients with BE who were treated with RFA.

The registry comprises 113 community-based and 35 academic-affiliated medical institutions in the United States. "About 75% of these institutions are private practices, so this is an interesting snapshot of RFA as it’s practiced outside of tertiary care centers," Dr. Shaheen said.

All study patients had BE confirmed by endoscopy and histology, and had undergone treatment with RFA. Enrollment commenced in July 2007 and ended in July 2011. Data were gleaned from standard case report forms and included demographics; relevant medical history; histologic grade prior to treatment; endoscopic findings; dates and total number of RFA treatment sessions; and ablation outcomes and complications.

"The vast amount of data is prospective, but less than 15% is retrospective," Dr. Shaheen said. "This is a registry study, so we could not mandate treatment, but a treatment protocol was suggested." Twice-daily use of proton pump inhibitors (PPIs) was recommended to everyone in the study, including those post fundoplication.

The mean age of patients was 61 years, and the majority were white. The mean pretreatment length of BE was about 4 cm, and patients received an average of 2.5 treatments with RFA. "Importantly, in this registry, about half of the patients had nondysplastic disease," Dr. Shaheen said. "Also, roughly 20% in each group had low- and high-grade dysplasia."

Dr. Shaheen reported results from the safety cohort, which included 5,537 patients who received RFA, and results from the efficacy cohort, which included 2,466 patients with biopsies performed 12 months after enrollment. Safety outcomes included perforation, stricture that required dilation, bleeding that required hospitalization or transfusion, and hospitalization. Efficacy outcomes included complete eradication of intestinal metaplasia and dysplasia.

Among patients in the safety cohort, 301 had a prior fundoplication, whereas 5,236 had received medical therapy only. Patients in the fundoplication group had a somewhat lower mean age than those in the medical therapy group (59 vs. 62 years, P = .0002), and were slightly less likely to be African American (0.3% vs. 1.6%, P = .03) or Hispanic (0.7% vs. 2.6%, P = .03). In the fundoplication group, the length of BE was greater (5.0 cm vs. 4.1 cm, P less than .0001), and the prevalence of nondysplastic BE was higher (53% vs. 49%, P = .05).

In addition, fewer patients in the fundoplication group were taking twice-daily PPIs compared with those in the medical therapy group (82% vs. 95%, P less than .001). There were no significant between-group differences in the rates of bleeding, hospitalization, or stricture.

Among patients in the efficacy cohort, 136 had a prior fundoplication and 2,330 had received medical therapy only. The fundoplication patients were slightly younger than the medical therapy patients (59 vs. 62 years, P = .004), had a somewhat greater length of BE (5.0 cm vs. 4.3 cm, P = .009), and were less likely to be taking twice-daily PPIs (75% vs. 93%, P less than .001).

Rates of complete eradication of intestinal metaplasia were 71% in the fundoplication group vs. 73% in the medical therapy group, a nonsignificant difference, while the rate of complete eradication of dysplasia was identical in both groups at 87%.

Among patients who had nondysplastic BE, 75% in the fundoplication group achieved complete eradication of intestinal metaplasia, compared with 81% in the medical therapy group, a nonsignificant difference.

Regarding combined efficacy for dysplastic BE and intramucosal carcinoma, 67% of patients in the fundoplication group achieved complete eradication of intestinal metaplasia, compared with 66% in the medical therapy group, and both groups had a rate of 87% for complete eradication of dysplasia; none of these differences were significant.

Dr. Shaheen acknowledged certain limitations of the study, including the fact that the functional status of the fundoplications was not known. "All we know is that some patients had them," he said. "These are observational data and subject to selection bias. Also note that this is hardly a pure comparison, because the people who got fundoplication were also getting PPIs. However, one might expect that to bias the study in favor of fundoplication, to the degree that the addition of PPIs helps."

The study was funded by Covidien, which provided the RFA equipment used in the study, and by grants from the National Institutes of Health. Dr. Shaheen disclosed that he has consulting relationships with numerous pharmaceutical and medical device companies, but none with Covidien.

SAN DIEGO – Radiofrequency ablation was found to be safe and effective in treating Barrett’s esophagus patients, whether or not they had undergone a prior fundoplication, based on results from a multicenter registry study.

"Gastroesophageal reflux causes esophageal mucosal injury and inflammation that may impair healing and squamous re-epithelialization after treatment of Barrett’s esophagus [BE] with radiofrequency ablation [RFA]," Dr. Nicholas J. Shaheen said at the annual Digestive Disease Week.

Photo courtesy Dr. Nicholas J. Shaheen

"It is unclear if fundoplication surgery, as a mechanical barrier to all reflux, improves treatment outcomes of RFA for BE. Similarly, some have postulated that change in the conformation of the hiatus with surgery might make ablation problematic."

Dr. Shaheen, director of the Center for Esophageal Diseases and Swallowing at the University of North Carolina, Chapel Hill, and his associates conducted the largest study of its kind, he said. They evaluated records from the RFA Patient Registry to assess the relationship between prior fundoplication and both efficacy and safety outcomes in patients with BE who were treated with RFA.

The registry comprises 113 community-based and 35 academic-affiliated medical institutions in the United States. "About 75% of these institutions are private practices, so this is an interesting snapshot of RFA as it’s practiced outside of tertiary care centers," Dr. Shaheen said.

All study patients had BE confirmed by endoscopy and histology, and had undergone treatment with RFA. Enrollment commenced in July 2007 and ended in July 2011. Data were gleaned from standard case report forms and included demographics; relevant medical history; histologic grade prior to treatment; endoscopic findings; dates and total number of RFA treatment sessions; and ablation outcomes and complications.

"The vast amount of data is prospective, but less than 15% is retrospective," Dr. Shaheen said. "This is a registry study, so we could not mandate treatment, but a treatment protocol was suggested." Twice-daily use of proton pump inhibitors (PPIs) was recommended to everyone in the study, including those post fundoplication.

The mean age of patients was 61 years, and the majority were white. The mean pretreatment length of BE was about 4 cm, and patients received an average of 2.5 treatments with RFA. "Importantly, in this registry, about half of the patients had nondysplastic disease," Dr. Shaheen said. "Also, roughly 20% in each group had low- and high-grade dysplasia."

Dr. Shaheen reported results from the safety cohort, which included 5,537 patients who received RFA, and results from the efficacy cohort, which included 2,466 patients with biopsies performed 12 months after enrollment. Safety outcomes included perforation, stricture that required dilation, bleeding that required hospitalization or transfusion, and hospitalization. Efficacy outcomes included complete eradication of intestinal metaplasia and dysplasia.

Among patients in the safety cohort, 301 had a prior fundoplication, whereas 5,236 had received medical therapy only. Patients in the fundoplication group had a somewhat lower mean age than those in the medical therapy group (59 vs. 62 years, P = .0002), and were slightly less likely to be African American (0.3% vs. 1.6%, P = .03) or Hispanic (0.7% vs. 2.6%, P = .03). In the fundoplication group, the length of BE was greater (5.0 cm vs. 4.1 cm, P less than .0001), and the prevalence of nondysplastic BE was higher (53% vs. 49%, P = .05).

In addition, fewer patients in the fundoplication group were taking twice-daily PPIs compared with those in the medical therapy group (82% vs. 95%, P less than .001). There were no significant between-group differences in the rates of bleeding, hospitalization, or stricture.

Among patients in the efficacy cohort, 136 had a prior fundoplication and 2,330 had received medical therapy only. The fundoplication patients were slightly younger than the medical therapy patients (59 vs. 62 years, P = .004), had a somewhat greater length of BE (5.0 cm vs. 4.3 cm, P = .009), and were less likely to be taking twice-daily PPIs (75% vs. 93%, P less than .001).

Rates of complete eradication of intestinal metaplasia were 71% in the fundoplication group vs. 73% in the medical therapy group, a nonsignificant difference, while the rate of complete eradication of dysplasia was identical in both groups at 87%.

Among patients who had nondysplastic BE, 75% in the fundoplication group achieved complete eradication of intestinal metaplasia, compared with 81% in the medical therapy group, a nonsignificant difference.

Regarding combined efficacy for dysplastic BE and intramucosal carcinoma, 67% of patients in the fundoplication group achieved complete eradication of intestinal metaplasia, compared with 66% in the medical therapy group, and both groups had a rate of 87% for complete eradication of dysplasia; none of these differences were significant.

Dr. Shaheen acknowledged certain limitations of the study, including the fact that the functional status of the fundoplications was not known. "All we know is that some patients had them," he said. "These are observational data and subject to selection bias. Also note that this is hardly a pure comparison, because the people who got fundoplication were also getting PPIs. However, one might expect that to bias the study in favor of fundoplication, to the degree that the addition of PPIs helps."

The study was funded by Covidien, which provided the RFA equipment used in the study, and by grants from the National Institutes of Health. Dr. Shaheen disclosed that he has consulting relationships with numerous pharmaceutical and medical device companies, but none with Covidien.