Folke Johnsson

Symptoms and Endoscopic Findings in the Diagnosis of Gastroesophageal Reflux Disease

Two hundred and twenty patients with symptoms suggestive of pathologic gastroesophageal reflux were investigated to elucidate the ability of symptoms and endoscopic findings in establishing a diagnosis of reflux disease as measured by ambulatory 24-h pH-monitoring. Daily occurrence of heartburn or acid regurgitation had positive predictive values of 59% and 66%, respectively. pH-monitoring showed pathologic reflux in 75% of patients with esophageal mucosal erosions. Endoscopic erythema of the distal esophagus predicted reflux disease in only 53%. Symptom registration during ambulatory 24-h pH-monitoring showed that about half of the symptomatic events reported by patients with pathologic reflux occurred within 5 min of a reflux episode. The corresponding figure for patients with normal pH-monitoring was less than 20%. We conclude that it is difficult to establish a diagnosis of gastroesophageal reflux disease by patient history alone, that erythema at endoscopy correlates poorly with pathologic reflux, and that reflux disease may be present even with normal endoscopy findings.

Cervical or Thoracic Anastomosis After Esophageal Resection and Gastric Tube Reconstruction: A Prospective Randomized Trial Comparing Sutured Neck Anastomosis With Stapled Intrathoracic Anastomosis

Objective: The purpose of the study was to compare in prospective randomized fashion a manually sutured esophagogastric anastomosis in the neck and a stapled in the chest after esophageal resection and gastric tube reconstruction. Summary Background Data: Despite the fact that all reconstructions after esophagectomy will result in a cervical or a thoracic anastomosis, controversy still exists as to the optimal site for the anastomosis. In uncontrolled studies, both neck and chest anastomoses have been advocated. The only reported randomized study is difficult to evaluate because of varying routes of the substitute and different anastomotic techniques within the groups. The reported high failure rate of stapled anastomoses in the neck and the fact that most surgeons prefer to suture cervical anastomoses made us choose this technique for anastomosis in the neck. Our routine and the preference of most surgeons to staple high thoracic anastomoses became decisive for type of thoracic anastomoses. Methods: Between May 9, 1990 and February 5, 1996, 83 patients undergoing esophageal resection were prospectively randomized to receive an esophagogastric anastomosis in the neck (41 patients) or an esophagogastric anastomosis in the chest (42 patients). To evaluate selection bias, patients undergoing esophageal resection during the same period but not randomized (n = 29) were also followed and compared with those in the study (n = 83). Objective measurements of anastomotic level and diameter were assessed with an endoscope and balloon catheter 3, 6, and 12 months after surgery. The long-term survival rates were compared with the log-rank test. Results: Two patients (1.8%) died in hospital, and the remaining 110 patients were followed until death or for a minimum of 60 months. The genuine 5-year survival rate was 29% for chest anastomoses and 30% for neck anastomoses. The overall leakage rate was 1.8% (2 cases of 112) with no relation to mortality or anastomotic method. All patients in the randomized group had tumor-free proximal and distal resection lines, but 1 patient in the nonrandomized group had tumor infiltrates in the proximal resection margin. At 3, 6, and 12 months after operation, there was no difference in anastomotic diameter between the esophagogastric anastomosis in the neck and in the thorax (P = 0.771), and both increased with time (P = 0.004, ANOVA repeated measures). Body weight development was the same in the two groups. With similar results in randomized and nonrandomized patients, study bias was eliminated. Conclusions: When performed in a standardized way, neck and chest anastomoses after esophageal resection are equally safe. The additional esophageal resection of 5 cm in the neck group did not increase tumor removal and survival; on the other hand, it did not adversely influence morbidity, anastomotic diameter, or eating as reflected by body weight development.

Endoscopic surveillance of columnar-lined esophagus - Frequency of intestinal metaplasia detection and impact of antireflux surgery

ObjectiveTo quantify the occurrence of intestinal metaplasia in columnar-lined esophagus (CLE) during endoscopic surveillance and to evaluate the impact of antireflux surgery on the development of intestinal metaplasia. Summary Background DataThe malignant potential in segments of CLE is mainly restricted to those containing intestinal metaplasia. Patients with segments of CLE in which no intestinal metaplasia can be detected are rarely enrolled in a surveillance program but may still be at increased risk of developing esophageal adenocarcinoma because intestinal metaplasia may be missed or may develop with time. MethodsThe occurrence of intestinal metaplasia on biopsy samples was determined on repeated endoscopies in 177 patients enrolled in a surveillance program for CLE. The incidence of intestinal metaplasia in patients with no evidence of intestinal metaplasia on the two first endoscopies was evaluated on the subsequent endoscopies and compared in patients with medically and surgically treated gastroesophageal reflux disease. ResultsIntestinal metaplasia was found in 53% of the patients (94/177) on their first surveillance endoscopy and was more prevalent in long segments of CLE. The prevalence of intestinal metaplasia increased markedly with increasing number of surveillance endoscopies. Intestinal metaplasia tended to be detected early in patients with long segments of CLE; in patients with shorter segments, intestinal metaplasia was also detected late in the course of endoscopic surveillance. Patients with surgically treated reflux disease were 10.3 times less likely to develop intestinal metaplasia compared with a group receiving standard medical therapy. ConclusionBiopsy samples from a single endoscopy, despite an adequate biopsy protocol, are insufficient to rule out the presence of intestinal metaplasia. Patients in whom biopsy specimens from a segment of CLE show no intestinal metaplasia have a significant risk of having undetected intestinal metaplasia or of developing intestinal metaplasia with time. Sampling error is probably the reason for the absence of intestinal metaplasia in segments of CLE longer than 4 cm, whereas development of intestinal metaplasia is common in patients with shorter segments of CLE. Antireflux surgery protects against the development of intestinal metaplasia, possibly by better control of reflux of gastric contents.

Heller's esophagomyotomy with or without a 360 degrees floppy Nissen fundoplication for achalasia. Long-term results from a prospective randomized study.

Hellers esophagomyotomy relieves dysphagia but does not restore esophageal peristalsis. The myotomy may induce reflux and the addition of a 360 degrees fundoplication may be hazardous with regard to the remaining aperistaltic esophagus. The aim of this prospectively randomized clinical trial was to compare the outcome for patients with uncomplicated achalasia who underwent an anterior Hellers esophagomyotomy (H group) with or without an additional floppy Nissen fundoplication (H + N group). Between 1984 and 1995, 20 patients were prospectively randomized to one or other of the performed operations, 10 patients per group. Esophagitis including Barretts esophagus (n = 2) was seen under medical treatment, in 6 of 9 in the H group but none in the H + N group. No patient in the H + N group required postoperative continuous acid-reducing drugs. Twenty-four-hour esophageal pH-studies in median 3.4 years after surgery showed pathological reflux expressed as a percentage of time below pH 4 of 13.1% in the H group compared to 0.15% (P < 0.001) in H + N group. One patient with recurrent dysphagia in the H + N group later had an esophagectomy. The remaining patients reported significant improvement of dysphagia without symptoms of reflux at 8.0 years follow-up. Hellers esophagomyotomy eliminates dysphagia, but can induce advanced reflux that requires medical treatment. The addition of a 360 degrees fundoplication eliminates reflux without adding dysphagia in the majority of patients and can be recommended for most patients with uncomplicated achalasia.

The reflux disease questionnaire: A measure for assessment of treatment response in clinical trials

BackgroundCritical needs for treatment trials in gastroesophageal reflux disease (GERD) include assessing response to treatment, evaluating symptom severity, and translation of symptom questionnaires into multiple languages. We evaluated the previously validated Reflux Disease Questionnaire (RDQ) for internal consistency, reliability, responsiveness to change during treatment and the concordance between RDQ and specialty physician assessment of symptom severity, after translation into Swedish and Norwegian.MethodsPerformance of the RDQ after translation into Swedish and Norwegian was evaluated in 439 patients with presumed GERD in a randomized, double-blind trial of active treatment with a proton pump inhibitor.ResultsThe responsiveness was excellent across three RDQ indicators. Mean change scores in patients on active treatment were large, also reflected in effect sizes that ranged from a low of 1.05 (dyspepsia) to a high of 2.05 (heartburn) and standardized response means 0.99 (dyspepsia) and 1.52 (heartburn). A good positive correlation between physician severity ratings and RDQ scale scores was seen. The internal consistency reliability using alpha coefficients of the scales, regardless of language, ranged from 0.67 to 0.89.ConclusionThe results provide strong evidence that the RDQ is amenable to translation and represents a viable instrument for assessing response to treatment, and symptom severity.

Randomized clinical trial of laparoscopic versus open fundoplication for gastro-oesophageal reflux

The aim of this study was to compare the long‐term results of laparoscopic and open antireflux surgery in a randomized clinical trial by investigating subjective and objective outcomes.

Wireless Esophageal pH Monitoring Is Better Tolerated than the Catheter-Based Technique: Results from a Randomized Cross-Over Trial.

OBJECTIVES:Esophageal pH monitoring using a wireless pH capsule has been suggested to generate less adverse symptoms resulting in improved patient acceptance compared with the catheter-based method although evidence to support this assumption is lacking. The aim of this study was to evaluate and compare the subjective experience of patients undergoing both techniques for esophageal pH monitoring.METHODS:Using a randomized study design, patients referred for esophageal pH testing underwent both wireless and traditional catheter-based 24-h pH recording with a 7-day interval. The wireless pH capsule was placed during endoscopy and followed by 48-h pH recording. All patients answered a questionnaire, including a 10-cm visual analog scale (VAS), which described the perceived severity of symptoms and the degree of interference with normal daily activities during the pH tests.RESULTS:Thirty-one patients, 16 women and 15 men, were included in the analysis. The severity of all adverse symptoms associated with the wireless technique was significantly lower compared with the catheter-based technique (median VAS 2.1 vs 5.1, P < 0.001). Wireless pH recording was associated with less interference with off-work activities and normal daily life, median VAS 0.6 and 0.7 compared with 5.0 and 5.7, respectively, for the catheter-based technique (P < 0.0001). Patients actively working during both tests reported less interference with normal work during the capsule-based test than during the catheter-based pH test (median VAS 0.3 vs 6.8, P = 0.005). Twenty-seven patients (87%) stated that, if they had to undergo esophageal pH monitoring again, they preferred the wireless test over the catheter-based pH test (P < 0.0001).CONCLUSIONS:This randomized study showed that a significant majority of patients undergoing esophageal pH monitoring preferred the wireless pH capsule over the traditional catheter-based technique because of less adverse symptoms and less interference with normal daily life.

Wireless oesophageal pH monitoring: Feasibility, safety and normal values in healthy subjects.

Objective A new wireless technique for oesophageal pH monitoring has recently been introduced (Bravo®). To implement this technique in clinical practice, values of normal oesophageal acid exposure need to be defined in a large age- and gender-matched healthy population. The aims of this study were to investigate the feasibility and safety of the wireless technique and to establish normal values for oesophageal acid exposure. Material and methods Fifty-seven asymptomatic subjects underwent upper gastrointestinal endoscopy with transoral placement of a radio-transmitting capsule 6 cm above the squamocolumnar junction. Oesophageal acid exposure was monitored via a portable receiver during 48 h. Results Seven men were excluded from the study: capsule dysfunction in 1 and oesophagitis in 6. Fifty subjects (25 M, 25 F, median age 42 years) were included in the study. The radio-transmitting capsule was successfully attached to the oesophageal mucosa in all cases and there were no complications. During pH monitoring 2 capsules were prematurely detached after 32 and 36 h, respectively. The median percentage time with oesophageal pH of less than 4 was 0.7% on day 1 and 1.0% on day 2 (p=0.033) and the 95th percentile for the 48-h recordings was 4.4%. Conclusions Ambulatory pH monitoring using the Bravo® system is feasible and appears to be safe. This is the first study to establish normal values for oesophageal acid exposure in a large age- and gender-matched healthy population and offers a basis for the use of the wireless technique in clinical practice.

Short-term outcome after laparoscopic and open 360 degrees fundoplication - A prospective randomized clinical trial

Background: Despite the lack of randomized trials supporting the laparoscopic approach, laparoscopic antireflux surgery has gained widespread acceptance during the last decade. The aim of this study was to compare the short-term symptomatic and objective outcome after laparoscopic and open 360° fundoplication in a prospective randomized clinical trial. Methods: Sixty patients with GERD were randomized to undergo either laparoscopic (LF) or open 360° fundoplication (OF). Endoscopy, esophageal manometry, 24-h pH monitoring, clinical symptom evaluation, and symptom scoring according to a validated questionnaire (the Gastrointestinal Symptom Rating Scale [GSRS]) was performed preoperatively and 6 months after surgery. Results: Five patients randomized to the laparoscopic group were converted to open surgery. Esophageal acid exposure was restored to normal in all patients. Lower esophageal sphincter length and resting pressure were significantly increased after both laparoscopic and open fundoplication (p <0.001); there were no differences between the groups. No significant differences were seen in symptomatic outcome, although there was a trend toward a higher rate of mild dysphagia (p = 0.051) after laparoscopic surgery. GSRS revealed a decrease in reflux score (p <0.001) and abdominal pain score (p <0.001) postoperatively. There were no significant differences in GSRS scores between the two groups. Conclusion: Laparoscopic 360° fundoplication is as effective in treating reflux disease as open fundoplication. Six months postoperatively, no significant differences were seen in symptomatic or objective outcome. Long-term evaluation is needed.

Randomized clinical trial of laparoscopic versus open fundoplication: evaluation of psychological well-being and changes in everyday life from a patient perspective.

Background: The laparoscopic approach in antireflux surgery might have an impact on the patients daily activities and well-being. Methods: Sixty patients were randomized to laparoscopic or open 360° fundoplication. Data were collected by questionnaires and interviews preoperatively, 1 month and 6 months after operation. Results: Five patients in the laparoscopic group were converted to open surgery. Psychological general well-being increased after surgery and reached norm values in both study groups. No significant differences were found between the two types of surgery in the per protocol analysis, while the domain self-control was significantly better after open surgery in the intention-to-treat analysis. There was improvement of diet and sleep in both study groups; after 6 months, disturbed sleep was significantly more uncommon after open surgery. Dysphagia and flatulence were new symptoms that were reported after surgery. Overall perception of the results of the operation did not differ between the groups. Conclusions: Psychological general well-being, diet and sleep improved after both laparoscopic and open surgery. There were only small differences between the groups, but in some respects the results were better after open surgery.