Achalasia; Mechanisms Underlying Persistent Symptoms After Treatment
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Oesophageal emptying
研究概览
简要总结
In patients with achalasia, the relationship between the perception of dysphagia, oesophageal emptying, lower oesophageal sphincter (LOS) distensibility and oesophageal circular and longitudinal muscle contraction is not clear.
We aim to characterize oesophageal circumferential and longitudinal muscle contractility and LOS distensibility in patients with achalasia (either before or after treatment). This may allow an understanding of the mechanisms underlying persistent dysphagia and delayed oesophageal emptying after treatment.
详细描述
This is observational study of patients with achalasia (with or without treatment). Treatment will have been a previous Heller's myotomy or pneumatic dilatation (and is not randomised). Patients with known or suspected achalasia will attend the GI physiology unit at the Royal London Hospital for standard care. Standard care involves assessing the perception of dysphagia with questionnaires, assessing oesophageal circular muscle function with high resolution oesophageal manometry (HRM) and oesophageal emptying with a timed barium oesophagram (TBO). The two experimental tests performed as part of the study (which are not currently routine care) are EndoFLIP and HFIUS.
On arrival at the GI physiology unit, patients will be given verbal and written information about the study (including standard care and non-standard tests). They will then be asked if they wish to participate. Informed written consent will be obtained.
Participants will complete questionnaires and HRM. If HRM is not consistent with achalasia, the patient's participation in the study ends. If HRM is consistent with achalasia then the participant will then undergo EndoFLIP, HFIUS and TBO.
Assessments are as follows (but are not necessarily done in the order given:
A. Perception of dysphagia (using MAYO and Eckardt questionnaires)
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with achalasia diagnosed on HRM criteria, with or without previous treatment
- •Written ICF signed voluntarily before the first trial-related activity.
- •Male or female, aged 18-70
- •If the subject is a woman of childbearing potential, she must have a negative urine pregnancy test before the start of assessments
排除标准
- •Any abnormal oesophageal motility finding that is not consistent with achalasia
- •History of gastrointestinal tract surgery, fundoplication, endoscopic anti reflux procedure or any other recent abdominal operation in the last 6 months
- •Major psychiatric, neurological, respiratory, liver, haemorrhagic and cardiac disorders, malignancies
- •Pregnancy
- •Subjects with a documented history of long segment (>3 cm) Barrett's oesophagus, large (> 3 cm) hiatus hernia, structural abnormalities of oesophagus (i.e. Rings, webs, scleroderma)
- •Use of prokinetic medication less than 7 days before the start of the study
- •Any condition that in the opinion of the Investigator would complicate or compromise the trial or the well-being of the subject.
- •Evidence of any clinically relevant pathology that could interfere with trial results or put subject safety at risk.
结局指标
主要结局
Oesophageal emptying
时间窗: Baseline (At recruitment )
Timed barium oesophagram
Oesophageal circumferential muscle contractility
时间窗: Baseline (At recruitment )
Using high resolution oesophageal manometry
Perception of dysphagia
时间窗: Baseline (At recruitment )
Questionnaires
Oesophageal longitudinal muscle contraction
时间窗: Baseline (At recruitment )
High frequency intraluminal oesophageal ultrasound
Assessment of oesophageal and LOS distensibility
时间窗: Baseline (At recruitment )
Using endoscopic functional luminal imaging probe (EndoFLIP)
次要结局
未报告次要终点