Quality of life and hepato-biliary related symptoms before and after endoscopic removal of bile duct stones (BDS): A randomized trial comparing endoscopic balloon dilatation of the biliary sphincter (EBD) and endoscopic sphincterotomy (EST)

EBD is a safe and effective alternative to EST for removal of BDS. Contrary to EST, EBD saves the function of the biliary sphincter and thereby preserves the physiological status of the biliary system. To investigate if this is associated with differences in subjective health perception by the patient, we prospectively evaluated the changes in quality of life and hepato-biliary related symptoms after EBD and EST. Methods: 202 patients, with BDS on ERCP, were randomized to undergo either EBD or EST. Prior to randomization and after six months follow-up, quality of life was assessed by the Nottingham Health Profile (NHP), a six-dimension questionnaire measure of subjective health status. In addition, the Amsterdam Castro-intestinal Symptom Profile (AGISP), a standardized questionnaire concerning hepato-biliary related symptoms, was completed at these time points. Results: Questionnaires were completed by 152 patients (75%). At randomization, both the EBD-group and EST-group demonstrated lower scores for all NHP dimensions compared to the general Dutch population. At six months follow-up, the scores of all NHP dimensions were significantly improved in both groups. The mean total NHP score rose from 80.5 (SD 18.7) to 90.3 (SD 14.7) in the EBD-group and from 76.0 (SD 19.9) to 85.8 (SD 18.6) in the EST-group. Improvement was not significantly different between the two groups. AGISP-scores also significantly improved during follow-up: the mean AGISP-score for the subset of symptoms compatible with bile duct stones rose from 35.4 (SD 33.8) to 92.3 (SD 21.6) in the EBD-group and from 42.6 (SD 36.3) to 93.3 (SD 20.1) in the EST-group. For the subset of symptoms of related to dyspepsia the mean AGISP-score changed from 69.3 (SD 29.8) to 91.5 (SD 15.9) in EBD-patients and from 72.2 (SD 23.0) to 90.3 (SD 17.2) in EST-patients. Again there were no significant differences between the two treatment groups. Conclusions: In patients with BDS, endoscopic stone removal significantly improves quality of life and hepato-biliary related symptoms. Using the NHP and AGISP, no significant differences in improvement of health status were observed during a six months follow-up between patients treated with EBD and patients treated with EST.