Safety and Efficacy of a Novel SpydrBlade Flexible Bipolar in POEM

Official title

Safety and Efficacy of the Novel SpydrBlade Flex With Radiofrequency and Microwave Ablation Flexible Bipolar for Per-Oral Endoscopic Myotomy in Patients With Achalasia: A Multicenter Prospective Study

Overview

Achalasia is an idiopathic motility disorder, primarily identified by the absence of esophageal peristalsis and the inability of the lower esophageal sphincter (LES) to relax properly. Although it is usually misdiagnosed and treated as gastroesophageal reflux disease (GERD), the main symptom is progressive dysphagia, accompanied by additional symptoms like nocturnal cough, heartburn, weight loss, regurgitation of undigested food and aspiration. The severity of achalasia and the effectiveness of treatments are commonly assessed using the Eckardt Symptom Score (ESS), which evaluates symptoms like weight loss, regurgitation, dysphagia, and retrosternal pain. Diagnosis of achalasia is often delayed, affecting up to 50% of patients. It typically involves a combination of diagnostic tools, such as time barium esophagram (TBE) study, which assesses the movement and clearance of barium in the esophagus; esophagogastroduodenoscopy (EGD), which allows visual examination of the esophagus, stomach, and duodenum; and high-resolution esophageal manometry (HREM), considered the gold standard for achalasia. HREM can also help stratify the condition into different types, influencing treatment choices. Furthermore, the endoluminal functional lumen imaging probe (Endoflip, Crospon Corp, Dangan Galaway, Ireland), which measures baseline parameters of LES, aiding in both diagnosis and treatment evolution. While there is no cure for achalasia, treatments aim to reduce LES pressure. The include pharmacological treatments, such as calcium channel blockers or nitrates; endoscopic treatment, including injection of botulinum toxin in the LES, pneumatic dilation, or per-oral endoscopic myotomy (POEM); and surgical therapies (laparoscopic Heller myotomy). POEM has emerged as a first-line treatment for achalasia due to its minimally invasive nature and high success rates (80%-90%). This technique involves creating a submucosal tunnel and performing myotomy, and it can be performed anteriorly (at 2 o'clock) or posteriorly (at 5 o'clock). The choice between anterior and posterior approaches to POEM often depends on the endoscopist's experience and preference. While current data is inconclusive regarding the superiority of either approach, some suggest that the posterior approach might be technically easier due to procedural characteristics (i.e., alignment between endoscopic accessories and mucosal incision). The introduction to novel technologies with smaller diameters can improve this minimally invasive approach making the procedure more efficient and safer for patients with achalasia. Thus, we aim to evaluate the safety and effectiveness of a novel radiofrequency and microwave ablation flexible bipolar (SpydrBlade Flex, CREO Medical, UK) for per-oral endoscopic myotomy in patients with achalasia.

Interventions

• Device SpydrBlade Flex
  The POEM procedure will be performed using the novel radiofrequency and microwave ablation flexible bipolar (SpydrBlade Flex, CREO Medical, UK). Both anterior and posterior POEM could be performed, depending on the clinical presentation and endoscopist's preference.

Primary outcome measures

• Technical Success Rate [Time frame: 1 day]
• Clinical Success Rate [Time frame: 30 days]
• [Safety] Incidence of intraoperative complications [Time frame: 1 day]
• [Safety] Incidence of postoperative complications [Time frame: 30 days]

Secondary outcome measures (5)

• Post-Procedural Reflux - Symptom Assessment [Time frame: 30 days]
• Post-Procedural Reflux - Endoscopic Features [Time frame: 6 months]
• Post-Procedural Reflux - pH Monitoring [Time frame: 30 days]
• Distensibility of the Lower Esophageal Sphincter (LES) [Time frame: 6 months]
• Postoperative Northwestern Esophageal Quality of Life questionnaire (NEQOL) score [Time frame: 6 months]

Eligibility criteria

Inclusion criteria

• Patients with 18 years of age or older.
• Patients referred to the participating center with a clinical indication for POEM. This includes conditions such as: achalasia, native or failed Heller myotomy, balloon dilation, and EGJ outflow obstruction.
• Patients who provide informed consent.

Exclusion criteria

• Patients who have contraindications for EGD.
• Patients with an Eckardt score < 3 before POEM.
• Positive diagnosis of Chagas disease.
• Patients unable to withstand general anesthesia.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

Ecuador · 1 center

• academy tertiary, IECED — Guayaquil

Hong Kong · 1 center

• Department of Surgery, Faculty of Medicine, the Chinese University of Hong Kong — Hong Kong

Publications

• Kamal F, Ismail MK, Khan MA, Lee-Smith W, Sharaiha RZ, Sharma S, McDonough S, Tariq R, Marella HK, Khan Z, Heda RP, Tombazzi C, Howden CW, Adler DG. Efficacy and safety of peroral endoscopic myotomy in the management of recurrent achalasia after failed Heller myotomy: a systematic review and meta-analysis. Ann Gastroenterol. 2021;34(2):155-163. doi: 10.20524/aog.2020.0563. Epub 2020 Dec 7. PMID 33654353
• Oleas R, Puga-Tejada M, Sanchez-Carriel M, Valero M, Martin-Delgado J, Ospina J, Munoz-Jurado G, Egas-Izquierdo M, Arevalo-Mora M, Alvarado-Escobar H, Pitanga-Lukashok H, Baquerizo-Burgos J, Robles-Medranda C. Spanish translation and validation of a hybrid, health-related quality of life questionnaire for chronic esophageal conditions: NEQOL-S. Neurogastroenterol Motil. 2023 Mar;35(3):e14511. doi: PMID 36502466
• Shiu SI, Chang CH, Tu YK, Ko CW. The comparisons of different therapeutic modalities for idiopathic achalasia: A systematic review and network meta-analysis. Medicine (Baltimore). 2022 Jun 17;101(24):e29441. doi: 10.1097/MD.0000000000029441. PMID 35713453
• Onimaru M, Inoue H, Fujiyoshi Y, Abad MRA, Nishikawa Y, Toshimori A, Shimamura Y, Tanabe M, Sumi K, Ikeda H. Long-term clinical results of per-oral endoscopic myotomy (POEM) for achalasia: First report of more than 10-year patient experience as assessed with a questionnaire-based survey. Endosc Int Open. 2021 Mar;9(3):E409-E416. doi: 10.1055/a-1333-1883. Epub 2021 Feb 19. PMID 33655041
• Haisley KR, Swanstrom LL. The Modern Age of POEM: the Past, Present and Future of Per-Oral Endoscopic Myotomy. J Gastrointest Surg. 2021 Feb;25(2):551-557. doi: 10.1007/s11605-020-04815-z. Epub 2020 Nov 2. PMID 33140317
• Cappell MS, Stavropoulos SN, Friedel D. Updated Systematic Review of Achalasia, with a Focus on POEM Therapy. Dig Dis Sci. 2020 Jan;65(1):38-65. doi: 10.1007/s10620-019-05784-3. Epub 2019 Aug 27. PMID 31451984
• Su B, Callahan ZM, Novak S, Kuchta K, Ujiki MB. Using Impedance Planimetry (EndoFLIP) to Evaluate Myotomy and Predict Outcomes After Surgery for Achalasia. J Gastrointest Surg. 2020 Apr;24(4):964-971. doi: 10.1007/s11605-020-04513-w. Epub 2020 Jan 14. PMID 31939098
• Moran RA, Brewer Gutierrez OI, Rahden B, Chang K, Ujiki M, Yoo IK, Gulati S, Romanelli J, Al-Nasser M, Shimizu T, Hedberg MH, Cho JY, Hayee B, Desilets D, Filser J, Fortinsky K, Haji A, Fayad L, Sanaei O, Dbouk M, Kumbhari V, Wolf BJ, Elmunzer BJ, Khashab MA. Impedance planimetry values for predicting clinical response following peroral endoscopic myotomy. Endoscopy. 2021 Jun;53(6):570-577. doi: 1 PMID 33147642

Identifiers

NCT: NCT07406945 · CRE-2024.464

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗