| Objective : In recent years,endoscopic treatments have become available to treat gastroesophageal reflux disease(GERD).Among them,endoscopic radiofrequency ablation(RFA)has the longest treatment experience.Foreign studies have shown that RFA is safe,effective,well tolerated and recommended it as a new method for GERD treatment.However,the feasibility and safety of the RFA treatment in Chinese patients with GERD,who differ from Western peoples in their physiological characteristics,are not known.Therefore,we conducted this single-center,prospective and self-controlled study to assess the safety and efficacy of RFA treatment for Chinese patients with GERD.Method: From July 1,2015 to December 18,2017,consecutive patients attending Changhai Hospital affiliated to the Second Military Medical University were enrolled.Detailed history data,surgical procedures,follow-up information were recorded.The primary outcome was the change of gastro-esophageal reflux disease health related quality of life(GERD-HRQL);The secondary outcomes were changes of medication use,esophageal acid exposure,lower esophageal sphincter(LES)resting pressure,reflux esophagitis(RE)and complications,such as bleeding,perforation and pain etc.Results: 31 patients underwent RFA,but 2 patients were lost to follow-up and 2 patients' follow-up time were less than 12 months.Finally,27 patients were included in the finnal analysis,including 20 males and 7 females.The mean age was 49.56 ± 12.31 years with a mean history of 5.99 ± 4.17 years.In terms of the primary outcome,RFA significantly improved GERD-HRQL of patients.GERD-HRQL score was 20.22 ± 9.44 at baseline off-medication,and it reduced to 9.22 ± 5.62 at 3 months after treatment,8.85 ± 6.34 at 6 months and 7.44 ± 6.27 at 12 months(P <0.001).Comparing the therapeutic effect of RFA with drug treatment further,the decrease of GERD-HRQL score after RFA was significantly lower than that after drug therapy(P = 0.025),suggesting that RFA was better than drug therapy.Besides,22 patients were unsatisfied with symptom control before RFA and 5 patients felt neutral,however,26 patients(96.30%)felt better(19 satisfied,7 neutral)at 12 months after RFA.In the secondary outcomes,the proportion of patients needing PPIs after RFA significantly decreased.Before treatment,27 patients(100%)had been taking PPIs to control the symptoms,while 3 months later,20(74.07%)patients reduced medication use and at 6 and 12 months after RFA treatment the patients reducing medication use increased to 23(85.19%)(p <0.001).In addition,17 patients(8 grade B,8 grade A,9)had existed RE before the RFA,while the RE relieved or healed in 11 and 13 patients at 6 and 12 months after RFA respectively(p <0.001).Furthermore,esophageal acid exposure decreased significantly after RFA.The median percentage of time esophageal pH <4 before treatment was 8.00%(range,4.50% to 59.30%),3.40%(range,0.20% to 25.10%)at 6 months after treatment,and 2.80%(range,0.40% ~ 26.00%)at 12 months(P <0.001).LES resting pressure also significantly increased from 15.83 ± 5.92 mmHg before treatment to 16.87 ± 5.98 mmHg at 6 months and 16.76 ± 5.89 mmHg at 12 months respectively after treatment(P <0.001).One patient(3.70%)had a small amount of bleeding during the procedure,and stopped after the hemostatic clip.No serious complications occurred during the follow-up.Conclusion:RFA treatment significantly improved the quality of life of patients with GERD,reduced the use of proton pump inhibitors(PPIs),improved the RE,decreased esophageal acid exposure,and increased LES resting pressure.And this new technology is simple,effective,fewer complications,and easy to be accepted by patients.So,it is worth promoting as a new treatment option for patients with GERD in our country.Meanwhile,we should continue to perfome clinical studies with large sample to further evaluate the efficiency,safety of RFA and compare the therapeutic effect of RFA with drug treatment. |
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