Original article
Clinical endoscopy
Impact of ablation of Barrett’s esophagus with low-grade dysplasia on patients’ illness perception and quality of life: a multicenter randomized trial

https://doi.org/10.1016/j.gie.2019.04.226Get rights and content

Background and Aims

A previous multicenter randomized trial demonstrated that radiofrequency ablation (RFA) significantly reduced the risk of neoplastic progression compared with surveillance (1.5% vs 26.5%) in patients with Barrett’s esophagus (BE) and low-grade dysplasia (LGD). In the same population, this study aimed to compare the quality of life (QOL) and illness perception (IP) among patients treated with RFA and patients kept under surveillance.

Methods

From June 2007 to June 2011, patients with BE and LGD were randomly assigned to RFA or surveillance. QOL and IP were assessed at baseline, 2, 9, 14, 26, and 38 months. Standardized questionnaires were used (SF-36, EORTC QLQ-C30, EORTC QLQ-OES18, and the brief Illness Perception Questionnaire [IPQ]).

Results

Forty-seven patients in the ablation group and 49 patients in the surveillance group completed the questionnaires (median follow-up, 36 months). Marginal differences were observed in the SF-36 and the EORTC-QLQ-C30. Based on the EORTC-QLQ-OES18, the ablation group reported more diarrhea (7.8 vs 4.0; P = .018), whereas the surveillance group reported more reflux (15.1 vs 9.0; P < .001) and more problems with speaking (4.3 vs 2.2; P = .019). The IPQ showed that patients in the ablation group perceived their disease lasted for a shorter period of time (P < .001), experienced fewer symptoms (P < .001), had fewer concerns about their condition (P < .001), and tended to be less emotionally affected by their condition (P = .012) than patients in the surveillance group. As a result, patients who underwent ablation experienced their condition as less threatening compared with patients in the surveillance group (P < .001).

Conclusion

Patients treated with ablation for BE with LGD reported a QOL comparable with that of patients undergoing endoscopic surveillance; however, the patients in the ablation group had fewer concerns and a less-threatening view of their condition. (Clinical trial registration number [www.trialregister.nl]: NTR1198; 25-1-2008.)

Introduction

Most (inter)national guidelines advise that patients with Barrett’s esophagus (BE) and confirmed low-grade dysplasia (LGD) should be treated with prophylactic radiofrequency ablation (RFA) instead of keeping patients under endoscopic surveillance.1, 2, 3 This advice is largely based on the results of 2 landmark studies. The AIM Dysplasia trial randomized patients with high-grade dysplasia (HGD) and LGD to either RFA or sham treatment. For patients with BE and LGD, after 12 months, they found that there was less disease progression from LGD to HGD/cancer in patients treated with RFA (5%) compared with sham-treated patients (14%), although this was not significant (P = .33).4 The SURF study was a randomized trial comparing endoscopic surveillance with prophylactic RFA treatment in patients with BE and confirmed LGD. This study showed that RFA reduced neoplastic progression from 26.5% to 1.5% compared with standard endoscopic surveillance.5 The trial was closed before all patients reached the projected 36-month follow-up, due to the superiority of RFA in preventing progression to HGD and esophageal adenocarcinoma (EAC).

Compared with surveillance, RFA is an invasive procedure, and in the SURF trial, 3 serious adverse events were observed (4-day admission for pain; postprocedural bleeding; admission and antibiotic treatment for fever after dilation of a stricture after RFA). In addition, 12% of patients developed a stricture after RFA requiring endoscopic dilation. In the surveillance group, no adverse events occurred (risk difference, 19.1%; 95% confidence interval [CI], 9.7%-28.4%; P < .001). Given the superiority of RFA in terms of preventing oncologic progression, this risk difference is considered to be acceptable by physicians. However, little is known about perceived health of patients during RFA treatment compared with surveillance. QOL and illness perception (IP) among patients with LGD may be influenced by the known risk of neoplastic progression and the need for regular endoscopic surveillance. QOL data as reported in the AIM Dysplasia Trial suggested that patients with BE and LGD and HGD who were randomized to RFA instead of sham experienced an improvement in disease-specific health-related QOL.6 This improvement seemed to be secondary to a perceived decrease in the risk of developing cancer.6 We hypothesized that ablation of confirmed LGD may have a negative short-term physical impact but improves long-term QOL and alleviates the fear and threat of the disease in a positive manner compared with standard endoscopic surveillance. As part of the randomized SURF-trial, we present QOL and IP among patients with confirmed LGD, comparing surveillance and ablation.5

Section snippets

Study design and patients

Patients were enrolled in the SURF trial between June 2007 and June 2011 in 9 centers from 5 European countries.5 In addition, QOL and IP was measured in the same patients. The Institutional Review Board of each center approved the study protocol (NTR1198; 25-1-2008; www.trialregister.nl). All authors had access to the study data and reviewed and approved the final manuscript. Patients with a histologically confirmed diagnosis of LGD and BE were randomly assigned in a 1:1 ratio to either RFA or

Results

For this study, 511 patients were screened, of whom 136 were found to be eligible and were randomized to RFA or surveillance. In 3 Dutch centers and 1 Belgian center, 111 patients participated in the study.5 The first 5 patients randomized in the Dutch and Belgian centers were not included in this QOL IP study. Four other patients did not consent to completing the questionnaires, and 6 patients were excluded because of other life-threatening co-morbidities. In total, 96 patients (47 patients in

Discussion

The role of RFA for patients with confirmed LGD in BE was investigated in the SURF trial, a randomized controlled trial comparing RFA with endoscopic surveillance. In addition, we investigated QOL and IP.

In both groups, the progression to HGD and EAC was assessed. The study showed that neoplastic progression was significantly lower (1.5%) in the ablation arm compared with the surveillance arm (26.5%).5 In our randomized trial of RFA versus endoscopic surveillance among patients with confirmed

Acknowledgments

This investigator-initiated trial was supported, in part, by Covidien GI Solutions (formerly BÂRRX Medical) and by the Maag Lever Darm Stichting grant WO 07-60 from the Dutch Digestive Diseases Foundation. Covidien GI Solutions provided ablation devices and access to a central electronic data management system.

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DISCLOSURE: Drs Bergman, Weusten, Bisschops, and Schoon have received funding from Covidien GI Solutions for Institutional Review Board–approved study protocols and have received a speaker’s fee for participation in postgraduate courses. Dr Bergman has received funding from Covidien GI Solutions for the development of training programs and post-graduate courses, has been involved in research and acted as a consultant for Medtronic GI Solutions, Boston Scientific, Cook Medical, Nine Point Medical, Olympus Endoscopy, Fujifilm Endoscopy, has undertaken research with C2 Therapedic and Erbe Medical, and received financial support from Medtronic GI Solutions. All other authors disclosed no financial relationships relevant to this publication.

If you would like to chat with an author of this article, you may contact Dr Bergman at [email protected].

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