跳至主要内容
临床试验/NCT04844190
NCT04844190撤回不适用

Use of Endoscopic Functional Lumen Imaging Probe (EndoFLIP) and Antroduodenal Manometry (ADM) in Predicting Clinical Response to Gastric Peroral Endoscopic Myotomy (G-POEM): A Pilot Study

Northwestern University2 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2021年9月15日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
入组人数
1
试验地点
2
主要终点
Predictive Value of ADM

研究概览

简要总结

The purpose of this study is to assess physiologic response of therapy in patients with refractory gastroparesis undergoing Gastric per-oral endoscopic myotomy (G-POEM) using endoscopic functional lumen imaging probe (EndoFLIP) and antroduodenal manometry (ADM). Refractory gastroparesis will be defined as having delayed gastric emptying at four hours (>10% retention of stomach contents) on gastric scintigraphy and persistent symptoms despite treatment with dietary modification or prokinetic medications. We hypothesize that EndoFLIP and high resolution ADM will provide an individualized pyloric functional profile in gastroparesis patients that can more accurately predict clinical response to G-POEM.

详细描述

Gastroparesis is defined as an objective delay in gastric emptying in the absence of mechanical obstruction with corresponding cardinal symptoms of postprandial fullness, early satiety, nausea, vomiting, bloating, and abdominal pain. Gastroparesis-related hospitalizations have increased by 158% in recent years as healthcare costs associated with gastroparesis have similarly risen exponentially by 1026% from 1997 to 2013.

Medical management of gastroparesis, primarily comprised of dietary and prokinetic therapy, is limited in effectiveness, tolerability, and durability, in part because the pathophysiologic mechanisms underlying gastroparesis are varied and multifactorial, including pyloric dysfunction, impaired fundic accommodation, vagal injury or neuropathy, gastric pacemaker dysrhythmias, hypocontractility, and aberrant gastric feedback. Pyloric dysfunction in particular, characterized by increased tone or pylorospasm, offers the potential for targeted endoscopic therapy in a subset of patients.

Gastric peroral endoscopic myotomy (G-POEM) has recently emerged as a feasible and safe treatment for severe refractory gastroparesis. Initially described in 2013, G-POEM is a minimally invasive technique that consists of creating a submucosal tunnel extending to the pylorus, dissecting circular and oblique muscle layers, and closing the tunnel with endoscopic clips. The first systematic review of early outcomes of G-POEM across 10 studies and 292 patients revealed 100% technical success, symptomatic improvement in 84%, and an adverse event rate of 6.8%.

However, a nuanced approach to appropriate patient selection for G-POEM, based on individual physiologic characteristics, is still lacking. The endoscopic functional lumen imaging probe (EndoFLIP; Crospon Inc., Galway, Ireland), previously well-described in assessing the lower esophageal sphincter in esophageal motility disorders, has been recently proposed as an adjunctive technology for evaluating pyloric sphincter compliance and distensibility. Few studies have investigated the efficacy of pyloric EndoFLIP in gastroparesis. Gourcerol et al. reported that gastroparesis patients have lower pyloric compliance compared to healthy volunteers, which also correlated with longer gastric emptying half times and reduced quality of life scores. A second pilot study of 20 gastroparesis patients who underwent pre- and post-myotomy EndoFLIP revealed that a distensibility index of <9.2 mm2/mmHg was associated with G-POEM clinical efficacy, however the study was limited by a short follow-up time of three months.

Antroduodenal manometry (ADM) has been the gold standard of assessing pyloric function and early studies revealed elevated pyloric pressures in greater than 50% of diabetics with gastroparesis. Recent data also shows a significant correlation between manometric and EndoFLIP pressures, though to date, no studies have utilized ADM in evaluating the efficacy of G-POEM. While conventional ADM was previously felt to be technically challenging and limited in availability, the advancement of high resolution manometry presents a unique opportunity for complementary assessment of not only pyloric pressures, but also antroduodenal pressure gradients.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All patients aged 18+ diagnosed with refractory gastroparesis as defined earlier in this document, no age limit
  • Patients already consented to undergo G-POEM

排除标准

  • Patients who are pregnant(at Northwestern, all female patients have urine pregnancy tests on day of endoscopy), vulnerable populations such as prisoners,
  • Life expectancy < 1 year based on concurrent comorbidities based on study team assessment,
  • Coagulopathy with INR > 1.5 that cannot be reversed,
  • Thrombocytopenia with platelets < 50,000 that cannot be corrected with blood products,
  • Unable to safely undergo elective endoscopy due to current comorbidities, and inability to pass standard endoscope.
  • Patients with history of gastric surgery and
  • Active narcotic use at time of G-POEM evaluation within four weeks. Tobacco use is not an exclusion criterion

结局指标

主要结局

Predictive Value of ADM

时间窗: 24 months

To assess the predictive value of high resolution ADM for clinical response to G-POEM in patients with refractory gastroparesis. We hypothesize that patients with a large, positive pressure gradient will be predictive of clinical response to G-POEM.

Predictive Value of EndoFLIP

时间窗: 24 months

To assess the predictive value of EndoFLIP for clinical response to G-POEM in patients with refractory gastroparesis. We hypothesize that patients with lower pyloric distensibility (measured in mm2/mmHg) will be predictive of clinical response to G-POEM.

次要结局

  • Number of participants with treatment-related adverse events as assessed by CTCAE v4.0(36 months)
  • EndoFLIP data correlation(24 months)
  • Quality of Life outcome of G-POEM(36 months)
  • Quality of Life outcome assessed by SF-36 QOL survey questionnaire(36 months)
  • Gastric-Emptying Characteristics(36 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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