Per-Oral Pyloromyotomy (POP) in the treatment of medical refractory gastroparesis : A randomized, sham-controlled trial

经口幽门肌切开术 (POP) 治疗难治性胃轻瘫：一项随机、假手术对照试验

• 批准号: 9973604
• 负责人: JOHN RODRIGUEZ
• 金额: $ 25.11万
• 依托单位: CLEVELAND CLINIC LERNER COM-CWRU
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-07-15 至 2025-03-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/9973604
• 关键词: Address; Albumins; Anatomy; Antiemetics; Bolus Infusion; Chronic; Clinical; Clinical Trials; Colloids; Consumption; Developed Countries; Devices; Diabetes Mellitus; Diet Modification; Discipline of Nuclear Medicine; Disease; Double-Blind Method; Egg White; Electric Stimulation; Electric Stimulation Therapy; Endoscopy; Epidemic; Etiology; Fatty acid glycerol esters; Food; Functional disorder; Gastrectomy; Gastric Bypass; Gastric Emptying; Gastric Pacemakers; Gastrointestinal Motility; Gastroparesis; Goals; Gold; Healthcare; Hospitalization; Hour; Iatrogenesis; Incidence; Intake; Intervention; Label; Laparoscopic Surgical Procedures; Malnutrition; Measures; Mechanics; Medical; Mission; Modality; Morbidity - disease rate; National Institute of Diabetes and Digestive and Kidney Diseases; Nausea; Nausea and Vomiting; Obstruction; Operative Surgical Procedures; Oral; Patients; Pharmaceutical Preparations; Phase; Placebo Control Effect; Prevalence; Procedures; Prospective Studies; Public Health; Pyloric sphincter structure; Pylorus; Quality of life; Questionnaires; Randomized; Refractory; Reporting; Research; Resources; Retrospective Studies; Risk; Safety; Small Intestines; Solid; Stomach; Stomach Diseases; Sulfur; Surveys; Symptoms; System; Technetium 99m; Techniques; Testing; Therapeutic; Therapeutic Intervention; Therapeutic Uses; Time; United States Food and Drug Administration; diabetic; early satiety; egg; functional outcomes; gastric retention; improved; indexing; innovation; novel; novel therapeutics; preservation; prospective; pyloroplasty; side effect; symptomatic improvement

PROJECT SUMMARY/ABSTRACT: Gastroparesis is a chronic, debilitating functional disorder of the stomach characterized by a delay in gastric emptying without evidence of mechanical obstruction. Classic etiologies of gastroparesis include idiopathic, post-surgical/iatrogenic, and diabetic. The incidence of gastroparesis is rapidly increasing coinciding with the diabetes epidemic in developed countries. Initial management of gastroparesis includes dietary modifications and prokinetic and/or antiemetic medications; however, these tend to lose efficacy over time and are often associated with intolerable side effects. Surgical therapy for gastroparesis is typically pursued once maximal medical therapy is no longer efficacious and may include gastric electrical stimulation, gastric bypass or subtotal gastrectomy in most cases. Disruption of the gastric pyloric sphincter (pyloroplasty, pyloromyotomy) has recently shown promise as a stomach-preserving option that does not involve the significant anatomical rearrangement required of gastrectomy. Per-oral pyloromyotomy (POP) is a novel endoscopic surgery that has shown promising utility for the management of medically refractory gastroparesis in several small single center studies. This intervention involves the division of the gastric pylorus via an endoscopic approach, accomplishing the same functional outcome of laparoscopic or open pyloromyotomy, without the invasiveness of open or laparoscopic surgery. Prior non-comparative retrospective studies have demonstrated both improvement of gastroparesis symptoms and improved gastric emptying. To date, there have been no prospective studies evaluating the efficacy of this procedure or comparisons to a control procedure. We aim to explore the utility of POP in producing symptomatic relief of gastroparesis-related symptoms as evaluated by validated scoring systems (Objective 1) and objective gastric emptying as measured by solid-phase scintigraphic gastric emptying studies (Objective 2). The proposed research is innovative in that it would additionally control for the placebo effect by blinding patients to receiving POP versus a sham intervention. This contribution would be significant as traditional gastroparesis therapies do not adequately address the clinical need, and supports the mission of the NIDDK to assess new therapeutic options in clinical trials. POP represents a potential intervention with far greater safety profile and less morbidity compared to other surgical modalities.

项目摘要/摘要： 胃轻瘫是一种慢性的、衰弱的胃功能障碍，其特征是 胃排空延迟，没有机械性梗阻的证据。经典病因病因学 胃轻瘫包括特发性、手术后/医源性和糖尿病。的发病率。 在发达国家，随着糖尿病的流行，胃瘫正在迅速增加。 胃瘫的初步治疗包括改变饮食和促进运动和/或 止吐药物；然而，随着时间的推移，这些药物往往会失去疗效，而且往往与 有无法忍受的副作用。胃瘫的手术治疗通常是一次。 最大限度的药物治疗不再有效，可能包括胃电刺激， 胃旁路手术或胃大部切除术占多数。胃幽门括约肌断裂 (幽门成形术，幽门肌切开术)最近显示出作为一种保胃选择的前景 不涉及胃切除所需的重大解剖重排。每口 幽门肌切开术(POP)是一种新型的内窥镜手术，已显示出良好的治疗效果。 几个小型单中心研究中药物难治性胃轻瘫的处理。这 干预包括通过内窥镜方法分割胃幽门， 实现与腹腔镜或开腹幽门肌切开术相同的功能结果，而不需要 开腹或腹腔镜手术的侵袭性。之前的非对比回溯性研究有 胃轻瘫症状和胃排空均有改善。至 到目前为止，还没有前瞻性研究评估这一程序的疗效或 与控制程序的比较。我们的目标是探索流行音乐在制作中的效用 胃瘫相关症状的症状性缓解通过验证评分进行评估 用固相闪烁照相测定系统(目标1)和目标胃排空 胃排空研究(目标2)。这项拟议的研究具有创新性，因为它将 另外，通过使患者盲目接受POP或假POP来控制安慰剂效应 干预。这一贡献将是重大的，因为传统的胃瘫疗法并不 充分满足临床需求，并支持NIDDK评估新的 临床试验中的治疗选择。民意调查代表着一种潜在的干预，具有更大的 与其他手术方式相比，安全性更高，发病率更低。