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: 10216251
• 负责人: Matthew Thomas Allemang
• 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/10216251
• 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; efficacy evaluation; 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、使人衰弱的胃功能障碍，其特征是 胃排空延迟，无机械性梗阻证据。经典病因 胃轻瘫包括特发性胃轻瘫、手术后/医源性胃轻瘫和糖尿病性胃轻瘫。发病率 随着糖尿病在发达国家的流行，胃轻瘫正在迅速增加。 胃轻瘫的初始治疗包括饮食调整和促动力和/或 止吐药物；然而，随着时间的推移，这些药物往往会失去功效，并且通常与 具有无法忍受的副作用。胃轻瘫的手术治疗通常一次进行 最大的药物治疗不再有效，可能包括胃电刺激， 大多数情况下进行胃绕道手术或胃次全切除术。胃幽门括约肌破坏 （幽门成形术、幽门肌切开术）最近显示出作为一种保留胃的选择的前景 不涉及胃切除术所需的重大解剖结构重新排列。口服 幽门肌切开术（POP）是一种新颖的内窥镜手术，已显示出有希望的实用性 几项小型单中心研究对医学难治性胃轻瘫的治疗。这 干预涉及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，而无需 开放或腹腔镜手术的侵入性。之前的非比较回顾性研究 证明胃轻瘫症状得到改善并改善胃排空。到 迄今为止，还没有前瞻性研究评估该程序的功效或 与控制程序的比较。我们的目标是探索 POP 在生产中的效用 通过验证评分评估胃轻瘫相关症状的症状缓解 系统（目标 1）和通过固相闪烁扫描测量的客观胃排空 胃排空研究（目标 2）。拟议的研究具有创新性，因为它将 通过让患者接受 POP 与假手术相比，另外控制安慰剂效应 干涉。这一贡献将是重大的，因为传统的胃轻瘫疗法不能 充分满足临床需求，并支持 NIDDK 评估新药物的使命 临床试验中的治疗选择。 POP 代表了一种潜在的干预措施，其作用要大得多。 与其他手术方式相比，安全性更高，发病率更低。