Research Article Clinics in Surgery Published: 20 Jun, 2018 Is Peroral Endoscopic Myotomy for Achalasia Safe in a Small-Volume Center? Rushfeldt C1*, Nordbø M1 and Goll R2 1Deptartment of Gastrointestinal Surgery, University Hospital of North Norway, Norway 2Deptartment of Gastrointestinal Medicine, University Hospital of North Norway, Norway Abstract Background and Aims: Peroral endoscopic myotomy (POEM) is a minimally invasive procedure for the surgical treatment of achalasia and an endoscopic alternative to open or laparoscopic Heller myotomy (HM). POEM was initially developed in Japan, was first published in 2010, and has since been increasingly adopted in Western countries. The aim of this study is to present preliminary data from the introductory phase of POEM in a small-volume center. Material and Methods: The first 14 patients operated with POEM for achalasia at the University Hospital of North Norway were registered in a prospective database and retrospectively evaluated, as a quality assurance study. Indications for the procedures were manometric diagnosis of achalasia and a significant Eckardt symptom score (≥ 7 points). Results: A total of fourteen patients, 6 female, median age 47 years (19-77 years), were operated in a day care unit and observed in the hospital ward for a median of 1 day (1-17 days). The preoperative and three month postoperative follow-up median Eckardt symptom scores were 8 (7-12) and 0 (0- 9), respectively. One complication was encountered, which resulted in an intraoperative mucosal perforation, and was subsequently treated with an endoscopically implanted stent. Four patients reported acquiring occasional gastro esophageal reflux disease (GERD), which did not necessitate regular antacid medication. Conclusion: Preliminary results from the introductory phase of POEM for achalasia in a small volume center demonstrate that the procedure was performed safely and with satisfactory short OPEN ACCESS term results. *Correspondence: Keywords: Per oral endoscopic myotomy; POEM; Achalasia Christian Rushfeldt, Department of Gastrointestinal Surgery, Division Introduction of Surgery, Oncology and Women’s Achalasia is a severe neuro-inflammatory disease of the esophagus causing dysfunction of Health, University Hospital of North the esophagus that, if not treated, results in weight loss and malnutrition [1]. A disturbance or Norway, 9038 Tromsø, Norway, Tel: 00- weakening of the esophageal peristalsis combined with a lack of relaxation of the Lower Esophageal 47-99794101; Sphincter (LES) when swallowing causes dysphagia with chest pain and regurgitation as concurrent E-mail: [email protected] symptoms. The condition is commonly misdiagnosed as GERD [2]. Received Date: 28 May 2018 Traditional treatments of achalasia include botulinum toxin injection to relax the LES, PBD Accepted Date: 13 Jun 2018 (pneumatic balloon dilation) to stretch the circular muscle fibers and finally surgical division Published Date: 20 Jun 2018 (myotomy) of the LES in order to assist the passage of food and liquid into the stomach. Botulinum Citation: toxin injection and PBD are considered to give only temporary symptomatic relief, whereas Rushfeldt C, Nordbø M, Goll R. Is myotomy results in a permanent solution for most patients [3]. Peroral Endoscopic Myotomy for Until quite recently an open or laparoscopic HM was the only surgical procedure in the Achalasia Safe in a Small-Volume treatment of achalasia. Fundoplication most often accompanies HM in order to prevent GERD Center?. Clin Surg. 2018; 3: 1993. after opening of the gastroesophageal junction (GE-junction) [4]. In 2010, the Japanese doctor Copyright © 2018 Rushfeldt C. This is Inoue H et al. published a new and revolutionary method for dividing the LES by an endoscopic an open access article distributed under technique based on a series of 17 patients [5]. This procedure quickly grew in popularity and became the Creative Commons Attribution widespread in the course of few years because of its minimally invasive nature [6,7]. Inoue’s novel License, which permits unrestricted endoscopic procedure spares patients open or laparoscopic surgery and has minimal impact on use, distribution, and reproduction in the patient, entailing only a small incision in the mucosa and myotomy of the circular muscle layer any medium, provided the original work including the LES. It is debated whether there is more reflux following POEM than HM combined is properly cited. with fundoplication but this question is not yet fully answered. Remedy Publications LLC., | http://clinicsinsurgery.com/ 1 2018 | Volume 3 | Article 1993 Rushfeldt C, et al., Clinics in Surgery - Gastroenterological Surgery Table 1: Patient and procedure data. the implementation of POEM, as a procedure already in use in many Number of patients (n) 14 other countries, is categorized as a quality assurance project with Age, year, median; (range) 47 (19-77) no requirement for disclosure or consent according to the rules of the Norwegian ethical committee. Due to its recent introduction as Female/male, n 8-Jun a surgical operative technique, POEM is registered in the National Type I/type II/type III achalasia, n 3/10/2001 Norwegian database for evaluation of new methods in hospitals at Resting LES pressure, mmHg, median; (range) 39 (26-68) The Norwegian Institute of Public Health. Barium esophagography diagnostic for achalasia, n 12 All patients were operated in a day care unit under general Previous pneumatic balloon dilation, n 5 anesthesia. Patients received prophylactic antibiotics intravenously as POEM procedure time, min., median;(range) 167 (110-219) well as Proton Pump Inhibitor (PPI) intraoperative. The esophagus Hospitalization after POEM, nights, median; (range) 1 (1-17) was washed with an antiseptic chlorhexidine solution 1 mg/ml (Fresenius Kabi, Halden, Norway). The operations were conducted CRP post-op. day 1, mg/L, median; (range)) 37 (5-73) with a gastro scope (Olympus GIF-HQ190, Olympus, Hamburg, Complications (intraoperative mucosal perforation) 1 Germany) with an oval, transparent cap on the tip (Fujifilm DH- Pre-op.Eckardt symptom score median; (range) 8 (7-12) 29CR, Tokyo, Japan) and with CO2 gas for insufflation. An Erbe VIO Post-op.Eckardt symptom score median; (range) 0 (0-9) 300 (ErbeElectromedicin GmbH, Tübingen, Germany) was used for diathermy. The POEM procedure used, as initially described by Inoue Post-procedure GERD, n 4 [5], is outlined below. A submucosal bubble was first created by injecting a solution of saline with 2% Indigo Carmine (Amino AG, Gebenstorf, Switzerland) approximately 14 cm cranial to the GE-junction between the 1 and 3 o’clock position using an endoscopic needle (Needle master NM- 610U-0426, Olympus). A 2 cm longitudinal incision was made in the lifted mucosa (Figure 1A) with a Triangle Tip knife (KD645-L, Olympus). This mucosal incision was used to create a 15 cm sub mucosal tunnel, which exposed the circular muscle layer. The sub mucosal tunnel was extended caudally and ended 3 cm caudal to the GE-junction (Figure 1B and 1C). The tunnel was washed with a gentamicin solution 80 mg/20 ml NaCl (Sanofi-Aventis, Paris, France). A 13 cm myotomy of the circular muscle was then performed. This myotomy, which included the LES, was made in a caudal direction from 2 cm below the lower edge of the mucosal incision to 3 cm below Figure 1: A) Primary mucosal incision, B) developing the submucosal tunnell the GE-junction (Figure 1D and 1E). Finally the mucosal incision was with inner circular muscle (CM) to the right, C) tunnellentrance with mucosa (MC) flap, D) outer longitudinal muscle (LM) exposed after myotomy of the closed with small clips (N1085930, Olympus) (Figure 1F). Free gas circular muscle, E) pericard (PC) is visible after spontaneous cleavage of in the abdomen was drained intra operatively with a left sub costal longitudinal muscle layer, F) clip-suturing of primary mucosa inscision. venflon if needed. The relatively small population of 0.5 million people in the region Patients were allowed to drink water immediately following served by the University Hospital of North Norway, combined with the operation and received analgesics as required. Patients stayed a low incidence of achalasia ranging from 1-2/100.000 implies few overnight in the ward and were discharged on the first postoperative cases per year [8]. In a small volume center it is crucial to demonstrate day if the clinical condition was satisfactory. No routine X-ray was a sufficient level of quality and safety in order to provide a given performed before discharge. They were allowed liquid nutrition surgical procedure. from day one with a gradual transition to solid food during the first week. Patients were given an extended antibiotic prophylaxis for five Methods days (doxycycline 100 mg ×1, metronidazole 400 mg × 3) and PPI From June 2016 to February 2018, 14 patients with achalasia were (pantoprazole 40 mg × 1) for one month. operated with POEM at the University Hospital of North-Norway A follow-up telephone interview was performed after three and prospectively registered in a database, which was analyzed months with an Eckardt symptom score. In addition, patients were retrospectively. The selection of patients suitable for POEM was asked if they experienced symptoms of GERD and if they still required based on a clinical scoring system for achalasia (Eckardt score) [9], the use of PPI medication. esophageal High Resolution Manometry (HRM) according to the Chicago classification [10], gastroscopy-findings and an esophageal Results X-ray after oral ingestion of barium contrast. Patients with an Eckardt In all, 14 patients, 6 female and 8 male, were included in the study. score of ≥ 7 out of a maximum of 12 points and manometric findings All patients with achalasia referred to The University Hospital of consistent with achalasia were selected for POEM if gastroscopy North-Norway during the study period fulfilled the criteria for POEM and barium esophagography excluded other esophageal diseases. operation with a significant Eckardt score (≥ 7) and a diagnostic Patients received written and oral information regarding the manometry.