Analysis of saliva pepsin level in patients with tracheoesophageal fistula and voice prosthesis complications.

The aim of this crossectional study was to investigate the relationship between pepsin concentration in saliva and the occurrence of tracheoesophageal fistula (TEF) complications and voice prosthesis (VP) complications, after total laryngectomy and VP implantation. We assessed the concentrations of pepsin in the saliva of 41 laryngectomized patients and correlated it with the incidence of TEF complications (periprostethic leakage, atrophy, esophageal mucosa hypertrophy, granulations, fistula enlargement, and VP dislocation), VP complications (transprosthetic leakage, Candida infection) and voice quality. Pepsin levels were measured by enzyme-linked immunoadsorbent assay (ELISA). Voice quality was assessed by Harrison-Robilard--Schultz (HRS) scale. In all, 17 (42%) patients had complications. All of them had TEF complications, whereas VP complication, together with TEF was found in 9 (22%) patients. We found no significant correlation between adjuvant radiotherapy and TEF complications. Most of patients, 30 (73%), had positive pepsin level in saliva. Median value of pepsin concentration in all patients was 4.8 (range 81.7). Median pepsin concentration was higher in patients free of TEF or VP complications (6.6, range 81.7 vs. 3.2, range 19.3) but that difference was not statistically significant (Mann-Whitney test, Z--1.562, p = 0.118). In addition, statistically insignificant negative correlation between pepsin levels and voice quality measured by HRS scale (Spearman's rho, p > 0.05). Although reflux was proposed as cause of TEF complications and pepsin has been proven as a most sensitive and specific marker of ekstraesophageal reflux, we did not find any statistically significant correlation between pepsin levels and occurrence of TEF or VP complications.