Reinforcement of intrathoracic oesophago-gastric anastomosis with fibrin sealant (Tisseel®) in oesophagectomy for cancer: A prospective comparative study.

PURPOSE: Fibrin sealant (Tisseel) is a human protein and thrombin soluble fibrinogen that has been indicated for reinforcement of gastro-intestinal anastomoses to prevent leakage. The objective of this study is to examine the impact of fibrin sealant regarding anastomotic leak, following Ivor-Lewis procedure.

METHODS

This is a prospective comparative study on 2-stage oesophagectomy for cancer of the distal oesophagus or oesophagogastric junction. N = 57 individuals were randomly subjected; n = 22 patients to Tisseel in combination to surgical anastomosis versus n = 35 patients to surgical anastomosis alone. The test of probability was assessed through Chi-Square, independent samples paired T-Test and Log-Rank analysis.

RESULTS

Of the 57 cases included, 56 underwent hybrid and 1 open oesophagectomy. In the Tisseel group, n = 5(22.7%) developed anastomotic leak comparing to n = 3(8.6%) of the control group. No statistically significant difference in leak rate was shown between the two groups; the test of probability was rejected.

CONCLUSIONS

Our results are not supportive of Tisseel tissue sealing property on the intrathoracic oesophago-gastric anastomosis and fibrin sealant's use cannot be justified.