Randomized Control Study Of Antibiotic Prophylaxis In Peroral Endoscopic Myotomy (POEM) For Achalasia

Bcakgroud:Idiopathic achalasia, caused by the neuromuscular disorder of the esophagogastric junction, is a benign disease. This disease is characterized clinically by symptoms of dysphagia, regurgitation, weight loss and chest pain. These symptoms are primarily caused by incomplete relaxation of a frequently hypertensive lower esophageal sphincter (LES) and to some extent by a lack of peristalsis in the tubular esophagus. There is no radical cure for achalasia. Modern treatments focus on relaxation or mechanical disruption of the LES, aim in relieving patients’symptoms, improving esophageal emptying, preventing the long-term development of mega-esophagus and restoring quality of life. Medications, endoscopic treatments and Heller myotomy are consisted of the treatments.Peroral endoscopic myotomy (POEM) dissects the circular and longitudinal esophageal muscular in the submucosal tunnel is a new emerging less invasive endoscopic treatment. POEM equals the minimal invasive and endoscopic Heller myotomy, has the same or better curative effect than Heller myotomy, and reduces the injury, hospital time and complications. However, no data demonstrates whether or not antibiotic prophylasix is necessary owing to the short time of development of POEM. Therefore, most of clinical doctors tend to antibiotic prophylaxis. Nevertheless more and more bacteria turn to antibiotic resistance as a result of irrationally abusing antibiotics. How to reasonably use antibiotic to effectively prevent infection is one of challenges for endoscopic treatments.The positive of blood culture is the golden criteria for using antibiotic. Unfortunately a certain period is needed to perform bacterial species identification and antibiotic susceptibilities test. Early, accurately, effectively diagnose infection requires the clinical doctor comprehensively consider symptoms, laboratory tests and radiographic outcomes. C reactive protein and procalcitonin has the high specificity and sensitivity in predicting infection.Objective:To evaluate the clinical value of antibiotic prophylaxis in POEM procedure for achalasia.Methods:This was a randomized, controlled, double-blind clinical trial.Subjects:69patients of achalasia were enrolled during November2012and March2013.5patients were excluded because of various reasons. A total of64patients were randomly divided into the trail group (T group, N=30) and the control group (C group, N=34).Contents:All patients started to fast one day before procedure and used Listerine to wash mouth more than three times half an hour before. Patients in T group were intravenously administrated2g of cefotiam30minutes before POEM for antibiotic prophylaxis and none in C group. No antibiotic was given in any patients after POEM except suspicious infection. Temperature was recorded before,12h after and the highest one was recorded in the24hours after POEM; blood cultures were done before,5minutes after, and12h after POEM; blood routine test, C-reactive protein (CRP) and proclacitonin (PCT) were monitored before,12h after POEM. Chest CT scan was performed in the post-operative day1. After7days of discharge, all patients received telephone follow-up to know temperature trend.Results:Two patients in C group were given antibiotic postoperatively because of hyperpyrexia and high white blood cell (WBC) count whereas nobody was given in T group. One patient’s aerobic blood culture was positive in5minutes after POEM grew streptococcus viridians in the C group. No significant relationship was observed in any tested parameters except the WBC counts at12hours after POEM. T group was significantly lower than C group (P=0.044). Meanwhile, temperature, WBC count, neutrophil ratio, CRP and PCT had no significant relationships between two groups with esophageal type, regurgitation score, past endoscopic treatment or Heller surgery, submucosal fibrosis, mucosal injury during procedure and operation time.Conclusion:POEM has a relatively low risk of bactermia; antibiotic prophylaxis can reduce the elevation of white blood cell count but cannot influence the incidence of transient bacteremia, pleural effusion and pneumonia. Antibiotic prophylaxis seems not necessary in patients who undergo POEM.