A Comparison of Underwater Versus Conventional Precoagulation Using Hybrid Knife in Peroral Endoscopic Myotomy for Esophageal Achalasia

Study Overview
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Brief Summary
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Achalasia is an idiopathic esophageal motility disorder, characterized by the insufficient relaxation of the lower esophageal sphincter (LES) and the absence of peristalsis in the esophageal body, leading to disabling symptoms, such as dysphagia, regurgitation, chest pain and weight loss. Until a few years ago, common interventional therapeutic approaches included botulinum toxin injection, endoscopic pneumatic balloon dilation and laparoscopic Heller myotomy. Nevertheless, the first options have proved only limited efficacy, while the surgical approach is highly invasive, costly and burdened by potential severe complications and a long recovery. First described by Inoue et al., peroral endoscopic myotomy (POEM) has recently been introduced as a novel treatment option. This innovative technique consists in creating a submucosal tunnel and cutting the esophageal muscular fibers with a less invasive approach than surgery. Due to the excellent clinical success rates achieved in both the short- and long-term with few adverse events, POEM has rapidly became one of the most common therapeutic approaches for esophageal achalasia. However, despite these great results, it is still an expensive, length, difficult and risky procedure. Indeed, the creation of submucosal tunnel is hampered by frequent intra-procedural bleeding that makes the procedure troublesome and time-consuming, requiring often the need of costly hemostatic devices such as the coagulation forceps. Such risk may also become clinically relevant as it may lead to major delayed bleeding that in turn may require hospitalization, blood transfusions and retreatment of the patient. No clear strategy to reduce the risk of intra-procedural and delayed bleeding has been put forward. Current practice consists of the preventive isolation and coagulation of the designed vessels during the submucosal tunneling. What the investigator propose in this protocol is a new technique to prevent the risk of bleeding and make POEM easier, quicker, safer and cheaper. Indeed, the invetsigators noticed that preventive underwater coagulation of the candidate vessels during the submucosal tunneling with the Hybrid Knife (HK), may seal the wall of the vessel, resulting in a subsequent cut under CO2 without any bleeding. Such preventive coagulation is likely to be related with the conduction of the current underwater as it focalizes all the power on the interface between the vessel and the water, allowing a soft sealing of the vessel without cutting it. The hypothesis of the investigators is that the implementation of this novel approach in clinical practice may lead to an increase in safety, feasibility and cost-effectiveness, reducing the procedural time, the rate of complications and the need for coagulation forceps in comparison with the conventional preventive coagulation technique under CO2 insufflation. Therefore, this randomized study compares the novel underwater precoagulation technique with the conventional precoagulation technique in the CO2 setting during the submucosal tunneling.

Official Title
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A Randomized Comparison of Underwater Versus Conventional Precoagulation Using Hybrid Knife in Peroral Endoscopic Myotomy for Esophageal Achalasia

Conditions
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Achalasia

Intervention / Treatment
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* Procedure: Coventional coagulation
* Procedure: Underwater coagulation
* Procedure: Peroral endoscopic myotomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All >18 years-old patients undergoing POEM for esophageal achalasia Exclusion Criteria: patients on antithrombotic/anticoagulant therapy patients suffering from bleeding disorders patients with esophageal and/or gastric varices patients previously treated with POEM or Heller myotomy patients who were not able or refused to give informed written consent. vessels equal or more than the knife inner diameter (120 μm)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: POEM with conventional precoagulation<br>POEM with conventional precoagulation | Procedure: Coventional coagulation<br>* Coventional coagulation<br>Procedure: Peroral endoscopic myotomy<br>* Peroral endoscopic myotomy<br>|
| Experimental: POEM with underwater precoagulation<br>POEM with underwater precoagulation | Procedure: Underwater coagulation<br>* Underwater coagulation<br>Procedure: Peroral endoscopic myotomy<br>* Peroral endoscopic myotomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bleeding | Rate of bleeding requiring the use of coagulation forceps | 12 months |