One- and ten-year outcome of laparoscopic anterior 120° versus total fundoplication: a double-blind, randomized multicenter study.

BACKGROUND: Nissen fundoplication is an effective treatment for gastroesophageal reflux disease (GERD) but can cause adverse effects like flatulence and dysphagia. The aim was to compare laparoscopic anterior 120° fundoplication (APF) to total fundoplication (Nissen) concerning flatulence and other adverse effects, in a randomized blinded study. METHODS: Seventy-two patients were randomized to APF (n = 36) or Nissen (n = 36). Gastroscopy, 24-h pH monitoring and evaluation for symptoms and quality of life using questionnaires (GSRS, PGWB and 7-graded Likert scales) were performed preoperatively, at 1 and 10 years postoperatively. Patients and the researchers were blinded to operative method. RESULTS: When entering the study, most patients had mild-moderate reflux disease according to the symptom score, the 24-h pH measurements, and frequency and grade of esophagitis. At 1-year (n = 68) flatulence, dysphagia, heartburn and acid regurgitation did not differ between groups. More patients could belch (p = 0.005), and pH monitoring showed a higher time with pH < 4 in the APF group (p = 0.006). At 10 years (n = 61), the APF group reported less dysphagia (p < 0.001), more heartburn (p = 0.019) and more patients could belch (p = 0.012) and vomit (p < 0.001) compared to the Nissen. No difference remained at 10 years in pH monitoring (n = 23) between groups. Symptoms of heartburn and acid regurgitation were less than preoperatively in both groups (p < 0.001). No revisional operations were performed. CONCLUSIONS: Both procedures offer good long-term control of reflux symptom, with modest post-fundoplication symptoms. Anterior 120° fundoplication results in less dysphagia, better ability to belch and vomit than total fundoplication at 10-year follow-up. The results suggest that APF could be an alternative to Nissen fundoplication in the surgical treatment of mild-moderate GERD.

Nitinol versus steel partially covered self-expandable metal stent for malignant distal biliary obstruction: a randomized trial.

BACKGROUND AND STUDY AIMS: Covered nitinol alloy self-expandable metal stents (SEMSs) have been developed to overcome the shortcomings of steel SEMS in patients with malignant biliary obstruction. In a randomized, multicenter trial, we compared stent patency, patient survival, and adverse events in patients with partly covered stents made from steel or nitinol. PATIENTS AND METHODS: A total of 400 patients with unresectable distal malignant biliary obstruction were randomized at endoscopic retrograde cholangiopancreatography (ERCP) to insertion of a steel or nitinol partially covered SEMS, with 200 patients in each group. The primary outcome was confirmed stent failure during 300 days of follow-up.  RESULTS: At 300 days, the proportion of patients with patent stents was 77 % in the steel group, compared with 89 % in the nitinol group (P = 0.01). Confirmed stent failure occurred more often in the steel SEMS group compared with the nitinol SEMS group, in 30 versus 14 patients (P = 0.02). Stent migration occurred in 13 patients in the steel group and in 3 patients in the nitinol group (P = 0.01). Median patient survival (secondary outcome) was 137 days and 120 days in the steel SEMS and nitinol SEMS groups, respectively (P = 0.59). CONCLUSIONS: The nitinol SEMS showed longer patency time, and the nitinol group had fewer patients with stent failure, compared with the steel SEMS group. We could not detect any differences between the two groups regarding survival time, and regarding adverse event rate.Clinical trial registration : NCT 00980889.

Diagnosing Barrett's oesophagus: factors related to agreement between endoscopy and histology.

BACKGROUND AND STUDY AIM: Few previous studies have addressed the agreement between endoscopy and histology regarding Barrett's oesophagus in unselected endoscopy patients. Our aim was to quantify this agreement, and to study its relation to clinical and endoscopic characteristics in consecutive patients coming for first-time gastroscopy. METHODS: We invited consecutive patients aged 18-79 years and endoscoped for the first time at endoscopy units exclusively serving defined catchment areas in southeast Sweden. Endoscopic and clinical data were recorded according to a predetermined protocol, and biopsies were taken from the distal oesophagus in all patients. RESULTS: Among 705 patients included, 17% [95% confidence interval (CI): 14-20] had endoscopically visible columnar mucosa above the oesophagogastric junction and 38% (95% CI: 34-42) had columnar mucosa in at least one biopsy irrespective of the endoscopic finding. The overall concordance between endoscopy and histology regarding presence (or absence) of columnar mucosa above the oesophagogastric junction was 74% (95% CI: 71-77) and the agreement beyond chance, as measured by Kappa (kappa) statistics, was fair, kappa=0.38 (95% CI: 0.32-0.45). The agreement between the endoscopic assessment and intestinal metaplasia at biopsy was 86% (95% CI: 83-88), but kappa was only 0.31 (95% CI: 0.21-0.41). Our data were consistent with a lower threshold for macroscopic detection of columnar epithelium above the oesophagogastric junction, when risk factors for Barrett's oesophagus were present. CONCLUSION: The agreement between macroscopic and microscopic assessments of Barrett's oesophagus is no more than fair, and partly dependent on the presence of patient characteristics suggestive of pathology in this region.

Losartan to prevent hyperenzymemia after endoscopic retrograde cholangiopan-creatography: A randomized clinical trial.

AIM: To study if the angiotensin II receptor blockers (ARB) losartan counteracts pancreatic hyperenzymemia as measured 24 h after endoscopic retrograde cholangiopancreatography (ERCP). METHODS: A triple-blind and placebo-controlled randomized clinical trial was performed at two Swedish hospitals in 2006-2008. Patients over 18 years of age undergoing ERCP, excluding those with current pancreatitis, current use of ARB, and severe disease, such as sepsis, liver and renal failure. One oral dose of 50 mg losartan or placebo was given one hour before ERCP. The relative risk of hyperenzymemia 24 h after ERCP was estimated using multivariable logistic regression, and expressed as odds ratio with 95% confidence intervals (CIs), including adjustment for potential remaining confounding. RESULTS: Among 76 participating patients, 38 were randomized to the losartan and the placebo group, respectively. The incidence rates of hyperenzymemia and acute pancreatitis among all 76 participating patients were 21% and 12%, respectively. Hyperenzymemia was detected in 9 and 7 patients in the losartan and placebo group, respectively. There were no major differences between the comparison groups regarding cannulation difficulty, findings, or proportion of patients requiring drainage of the bile ducts. There were, however, more pancreatic duct injections, a greater extent of pancreatography, and more biliary sphincterotomies in the losartan group than in the placebo group. Losartan was not associated with risk of hyperenzymemia compared to the placebo group after multi-varible logistic regression analysis (odds ratio 1.6, 95%CI 0.3-7.8). CONCLUSION: In this randomized trial 50 mg losartan given orally had no prophylactic effect on development of hyperenzymemia after ERCP.

Pancreatic acinar metaplasia in the distal oesophagus and the gastric cardia: prevalence, predictors and relation to GORD.

PURPOSE: The nature of pancreatic acinar metaplasia (PAM) in the gastro-oesophageal junction (GOJ) remains obscure. We aimed to estimate its prevalence and investigate into its risk factors in a population-based series of first-time endoscopy patients. METHODS: We investigated consecutive patients, endoscoped for the first time, representing defined catchment area populations. Biopsies were taken immediately below the GOJ and from the distal oesophagus. Endoscopy room-based cross-sectional clinical data were supplemented with exposure data from 160 population controls. Associations, expressed as odds ratios (OR), were modelled with multivariable logistic regression. A subsample of 26 patients underwent oesophageal pH monitoring. RESULTS: Among 644 patients (mean age 53 years, 43% men), PAM was found in 121 patients (19%), exclusively above the GOJ in 40 (6%), below GOJ in 67 (10%), and both above and below GOJ in 14 (2%). PAM exclusively above the GOJ and PAM exclusively below the GOJ were both borderline associated with age (2% increase in prevalence per year). PAM exclusively above the GOJ was significantly associated with female gender (OR 2.8, 95% CI 1.3-6.3) and presence of Helicobacter pylori immediately below the GOJ (OR 2.6, 95% CI 1.3-5.4). Out of 21 patients with Barrett's oesophagus (BO), 8 (38%) had PAM above the GOJ. The mean value for percentage time with oesophageal pH < 4.0 was 7.3% (95% CI 4.3-10.2%) among patients who had PAM above the GOJ (reference value 3.4%). CONCLUSIONS: Pancreatic acinar metaplasia might be an age-dependent lesion, associated with H. pylori, female gender and gastro-oesophageal reflux if located above the GOJ.

Risk factors for Barrett's oesophagus: a population-based approach.

OBJECTIVE: Given its often subclinical course, Barrett's oesophagus (BO) hardly lends itself to epidemiologically stringent evaluations. The objective of this study was to investigate risk factors for incident BO diagnosed in a defined population in southeast Sweden while paying particular attention to epidemiological aspects of the study design. MATERIAL AND METHODS: Consecutive patients (aged 18-79 years) who were endoscoped with new indications at units exclusively responsible for all gastroscopies in defined catchment area populations were invited to take part in the study. Biopsies were taken above and immediately below the gastro-oesophageal junction, and exposure information was collected through self-administered questionnaires. Endoscopy-room-based cross-sectional data from 604 patients were supplemented with exposure data from 160 population controls. Associations, expressed as odds ratios (ORs), were modelled by means of multivariable logistic regression. RESULTS: In the comparison with population controls, reflux symptoms and smoking indicated a 10.7- and 3.3-fold risk, respectively, for BO (95% confidence interval (CI) 3.5-33.4 and 1.1-9.9, respectively). Body mass was unrelated to risk. In the cross-sectional analysis among endoscopy-room patients, reflux symptoms were associated with an OR of 2.0 (95% CI 0.8-5.0). This association was, however, modified by the subjunctional presence of Helicobacter pylori; although the infection was not in itself significantly connected with risk, a combination of reflux symptoms and H. pylori infection was linked to an almost 5-fold risk (95% CI 1.4-16.5) as compared with the absence of both factors. The BO prevalence increased by 5% per year of age (95% CI 1-9%). CONCLUSIONS: Reflux is the predominant risk factor for BO, and proximal gastric colonization of H. pylori seems to amplify this risk.

Prevalence of precancerous and other metaplasia in the distal oesophagus and gastro-oesophageal junction.

OBJECTIVE: The epidemiology of Barrett's oesophagus (BO) is characterized by divergent results. The aim of this study was to estimate the prevalence of BO and intestinal metaplasia (IM) at the gastro-oesophageal junction (GOJ) in a population-based series of patients referred for first-time gastroscopy. MATERIAL AND METHODS: Consecutive patients who underwent endoscopy for the first time at endoscopy units exclusively serving defined catchment areas were invited to take part in the study. Biopsies were taken immediately below the GOJ and from the distal oesophagus, and clinical data were recorded. RESULTS: A total of 769 patients (mean age 53 years, 43% M) were examined. Overall IM prevalence was 14%. BO was noted in 4%. Overall, the prevalence of IM increased by 8% (95% CI 6-10%) per year of age. BO patients were predominately women (69%). Presence of cardia-type mucosa in the cardia increased with age from 25% among the youngest to 59% among the oldest patients. Pancreatic acinar metaplasia (PAM) was found in 18%. CONCLUSIONS: While BO is not common among Swedish gastroscopy patients, IM and PAM are found in every 7th and 6th patient, respectively. Age-dependent increments in prevalence suggest that not only BO and IM, but also cardia-type mucosa are acquired and/or progressive lesions.