Stretta radiofrequency treatment vs Toupet fundoplication for gastroesophageal reflux disease: a comparative study

A total of consecutive 230 patients diagnosed with GERD and underging TF (n = 142) and SRF (n = 88) at our hospital between January 2014 and June, 2017 were enrolled in the retrospective study. GERD was diagnosed by endoscopy showing esophagitis or abnormal esophageal pH, a DeMeester score ≥ 14.7 with symptom correlation of ≥50%, and/or > 73 reflux episodes during 24-h ambulatory impedance monitoring period, lower than normal LES pressure by esophageal manometry. They were endoscopically confirmed to have Los Angeles grade A or B esophagitis, with non-hiatal hernia or small (< 2 cm) hiatal hernia. Patients were included if they were 18 years old or older, had clinical symptoms such as regurgitation, retrosternal pain and heartburn. Patients were excluded if they had diseases in the central nervous system or connective tissue, were previously performed esophageal or gastric surgery. Patients with esophageal stricture, shortened esophagus, impaired distal esophageal peristalsis, autoimmune diseases, collagen vascular diseases, Barrett’s esophagus, coagulation disorders, acute heart failure, cardiogenic shock and other important organ diseases and previous thoracic surgery were also excluded. Patients who had medications that affect the secretion of gastric acid and gastrointestinal motility within 7 days were also excluded to avoid the impact of the medication on evaluation of the therapeutic effect.

Patient demographics and clinical data at the time of diagnosis, including age, gender, duration of typical GERD symptoms prior to diagnosis, past and present medications, dietary inhibits, smoking, and clinical symptoms of typical GERD, were collected.

The study protocols were approved by the Ethical Review Committee of Hebei Medical University (Approval no HMU-2212, Nov, 2013) and conform to the ethical guidelines of the 1975 Declaration of Helsinki. Written consent was obtained from each patient included in the study.

TF was performed under general anesthesia. The type of TF was either all laparoscopic or open or mix. After laparotomy, the abdominal esophagus was isolated. The left and right cruses of diaphragm were sutured for 1–2 sutures to close the esophageal hiatus. One cm gap was left between the top first suture and the esophagus to allow the patency of esophagus. Then, the gastric fundus was folded at 270 degrees and fixed with 2–3 sutures at the gastric fundus and on both sides of esophagus.

For SRF, the procedure was performed according to Triadafilopoulos [19]. Briefly, during a deeply sedated esophagogastroduodenoscopy (EGD), the eligibility was confirmed and the distance of the squamo-columnar junction (used as the approximate location for the gastroesophageal junction) was measured. A guide wire was introduced to the duodenum through the EGD, and the EGD was then withdrawn. A RF delivery catheter (Kanglian Medical Equipment Co., Ltd., Beijing) from a radiofrequency device (S500L, CURON MEDICAL Inc., USA) was inserted orally using the guide wire. The Stretta catheter is made up with an inflatable and flexible balloon-basket with four electrode needles. The balloon was inflated when it was 2 cm proximal to the squamo-columnar junction to deploy the electrode needles (22-gauge, 5.5-mm length). RF energy was delivered for 60 s. The needles were then withdrawn. After the balloon was deflated, and the catheter was rotated 45° to delivery radiofrequency. This process is repeated every 0.5 cm to cover the area 2 cm above and 1.5 cm below the squamo-columnar junction and six sets below the cardias for a total of 14 sets of needle deployments.

Reflux time and frequency, the DeMeester score, LES pressure, esophageal pH and prognosis were recorded, measured and analyzed. GERD relapse was the primary endpoint. The DeMeester score was measured as described previously [20]. A DeMeester score of > 14.7 was regarded as having reflux. LES pressure was measured using XDJ-S8S Esophageal Motility System (Kelly Photoelectrics Technology Co., Ltd., Hefei, China) according to the manufacturer’s instructions. Medications such as anti-cholinesterase drugs and acid-suppressing agents that may affect esophageal motor function and secretion of gastric acid were discontinued 7 days before the assessment. Patients were fasting for 4 to 6 h before the pressure measurement. Esophageal pH was measured using Digitrapper pH-Z Recorder with combined pH-Impedance (Given Imaging Ltd., USA) by inserting calibrated pH electrodes from the nasal cavity to 5 cm above LES. The esophageal pH at three meals, standing position and lying position was recorded for 24 h to calculate the DeMeester score. If the pH was < 4 and DeMeester score was greater than 14.72, it was regarded as acid reflux. The outcome was classified as good or poor prognosis. The poor prognosis included events such as dysphagia, abdominal distention, diarrhea, chronic stomach pain and recurrence of GERD. The patients were followed up for 1 year at 2 month intervals.

Data were analyzed with SPSS 17.0 software (SPSS Inc., Chicago, IL, United States) and were presented as the mean ± SD for continuous variables and as percentages and proportions for categorical variables. For the statistical analyses, the Kolmogorov-Smirnov test was used to assess the normality data. Independent t-test was applied to compare the means between two groups. Two-factor repeated measures ANOVA was used to compares the means between repeated measurement data. Counting data were expressed as percentage and tested using X² test or the Fisher’s exact probability method. The stepwise Cox regression procedures were used to analyze the risk factors affecting prognosis. A value of P value < 0.05 was considered statistically significant.

At the end of follow-up, two patients each were lost in the TF group and the SRF group. As a result, 140 patient in the TF group and 86 patients in the SRF group were analyzed. Mean age was 53.7 (± 6.1) and 62.8% were males. Mean duration of GERD was 12.3 (± 7.3) years and the mean body mass index (BMI) was 28.2 ± 8.6. There were no difference in the gender, age and BMI between the two groups. 71% patients had chronic comorbid conditions. The most common comorbidity was hypertension (30.9%) followed by coronary heart disease (23.8%) and diabetes mellitus (16.3%). However, the percentages of patients with these comorbidities were not different between the groups (Table 1).

Before and 12 month after GERD treatments, the mean time and frequency of reflux, and percentage of reflux time were not significantly different between the two groups (P > 0.05, Table 2).

Before, 2 and 12 months after GERD treatments, the DeMeester score and LES pressure had significantly interactions over the treatment and time (P < 0.05), and there were significant main effects on the DeMeester score and LES pressure by the treatment and follow-up time (P < 0.05). The DeMeester score was significantly higher in the SRF group than in the TF group (8.8 vs 7.3. P < 0.05), while LES pressure was the opposite (11.6 vs 12.8, P < 0.05, Table 3). However, at 2 months after operation, these parameters were similar between the groups (P > 0.05, Table 3).

The overall percentages of poor prognosis as measured by adverse events were 21.4% (30/140) in the TF group and 11.6% (10/86) in the SRF group, which were not significantly different (P > 0.05, Table 4). The incidences of dysphagia, abdominal distension, diarrhea, chronic stomach pain and recurrence of GERD were not different significantly between the two groups (P > 0.05, Table 4), although there were two relapse GERD patients in SRF group.

Factors resulting in poor prognosis and adverse events were analyzed using multivariate Cox proportional regression using prognosis after treatment as dependent variable (good prognosis = 0, and poor prognosis =1). Time and frequency of reflux, and percentage of reflux time, the DeMeester score and LES pressure at the 1 year mark were included in the analysis. The results showed that for TF patients, high reflux number [RR = 1.701, 95% CI (1.929, 3.981), P = 0.035], DeMeester score [RR = 1.867, 95% CI (1.232, 2.370), P = 0.001] and low LES pressure [RR = 1.399, 95% CI (1.909, 2.196), P = 0.0347] were risk factors for poor prognosis. Similarly, high reflux frequency [RR = 1.581, 95% CI (1.168, 2.145), P = 0.022] and the DeMeester score [RR = 1.899, 95%CI (1.522, 2.658), P = 0.004)], and low LES pressure (RR = 1.856, 95% CI (1.565, 4.677), P = 0.015) were risk factors for poor prognosis in SFR group (Tables 5 and 6).