THE NATURAL CLINICAL COURSE AFTER PER-ORAL ENDOSCOPIC MYOTOMY: IS MICROBIAL TRANSLOCATION THE KEY? A PROSPECTIVE RANDOMIZED CLINICAL TRIAL

Aims Microbial-translocation(MT)is the passage of viable/nonviable-microbes across the GI-barrier. The presence of Lipopolysaccharides(LPSs)in plasma has been correlated to sepsis/septic shock through inflammation(IN)activation via the production of soluble-CD14(sCD14)and LPS-binding-protein(LBP)which initiates cytokines(IL-6,IL-1b,TNF-α). Considering POEM a clean-contaminated procedure, it should be assessed whether the post-POEM fever/inflammation is cytokine-mediated/infection-related. Our aim was to evaluate the presence of IN-mediators, bacteremia and MT post-POEM.

Methods All consecutive POEM patients were enrolled and randomized in two groups: Group-A(only prophylaxis) and Group-B(prophylaxis+short-therapy).At planned timing(T0:before-POEM;T1:after-POEM;T2:24hours after-POEM) we evaluated plasma dosage of IL-6(IN),IL-1β(IN),TNF-α(IN),sCD14(MT),LPB(MT).Blood cultures(BC) and body temperature(BT)were collected at T0,T1,T2,WBCs and C-reactive-Protein(CRP)was evaluated at T0,T2.(NCT:03587337)

Results None of the enrolled patients(n=124), experienced post-op fever(p=ns) except for 1 in Group-B(BT:t2 38.2°C). Both groups showed post-POEM systemic-inflammation:CRP and WBCs increased from t0 to t2(p< 0.0001). No difference between the groups:t2:CRP(p=0.99),t2:WBC(p=0.44). IL-6 increased from t0 to t2(p=0.018). IL-1b and TNF-α decreased from t0 to t2:IL-1b(p=0.023),TNF-α(p=0.055). MT-markers increased from t0 to t2,sCD14(p=0.022),LBP(p< 0.0001). No marker showed any difference between groups. We found correlations at t2 between IL-6 with:TNF-α(p< 0.0001),IL-1b(p< 0.0001) and CRP(p< 0.007). At t2, LBP did not correlate with:WBCs(p=0.29),CRP(p=0.42), nor with BT(p=0.82). At t1, BC were positive in 5 patients(4%), 4 in Group-B, 1 in Group-A. All negative at further analysis(t2).

Conclusions After POEM, a certain degree of MT, expressed by sCD14 and LBP, occurs. Given the absence of a post-operative clinical-manifestation(fever), it is understandable that, thanks to the prophylaxis/short therapy, the risk of developing infective-sequelae(bacteremia/sepsis) is counteracted. A low rate of bacteremia post-POEM was reported(4%); since the negativity of blood cultures at t2 and no clinical-correlates were present, it appears transient; POEM might be therefore considered as a safe procedure. Not finding any clinically/statistically significant difference among the two groups we proved that a prolonged short-therapy exceeds the need of avoiding the infectious risk and that the single antibiotic prophylaxis appears to be the correct approach.