An Investigation of Electrical Stimulation on Gastroesophageal Reflux Disease (GERD) in Patients After Sleeve Gastrectomy
2014年8月6日 更新者：Maastricht University Medical Center
Sleeve gastrectomy (SG) has gained popularity as both a staged and a definitive procedure for morbid obesity due to its technical simplicity, low-morbidity and excellent results both for weight loss and control of metabolic syndrome. There are however reports of SG worsening pre-existing GERD or causing new-onset GERD. Because of this, patients with pre-existing GERD have been denied the benefits of SG. In addition, patients that develop post-op GERD cannot undergo traditional anti-reflux surgery since the gastric fundus that is required for fundoplication is removed during the SG. Hence, patients with post-SG GERD not adequately controlled with medication can only opt for the more invasive gastric bypass procedure as their only surgical treatment option.
In a recently reported case study, an obese patient with severe GERD successfully treated with EndoStim underwent SG and maintained adequate GERD control with continued use of LES stimulation therapy. However electrical stimulation was not yet tested systematically in patients with prior gastric operation such as sleeve gastrectomy.
This study will test the hypothesis that electrical stimulation is effective in control of GERD associated with SG.
調査の概要
研究の種類
介入
入学 (予想される)
10
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Maastricht、オランダ、6229 HX
- 募集
- Maastricht University Medical Center
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コンタクト：
- Nicolaas F Rinsma, MD
- 電話番号：+31433884190
- メール：n.rinsma@maastrichtuniversity.nl
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主任研究者：
- Nicole D. Bouvy, MD PhD
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副調査官：
- José M Conchillo, MD PhD
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副調査官：
- Nicolaas F. Rinsma, MD
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副調査官：
- Selwyn Van Rijn, MD
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年～80年 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- Subject is between 18 - 80 years of age.
- Subject underwent a sleeve gastrectomy minimum one year prior to enrollment (in order to have reached a stable weight loss plateau).
- Subject has a history of heartburn, regurgitation or both for >6 month prompting physician recommendation of continual daily use of PPI after sleeve gastrectomy.
- Baseline off-PPI GERD-HRQL score ≥ 20 following 10-14 days off PPI
- Baseline off-PPI GERD-HRQLscore is at least 5 points higher than the on-PPI score or a positive relationship between the occurrence of their primary symptom during the pH impedance monitoring (symptom association probability ≥ 95% or a SI score ≥ 50%) is present.
- Subject who are on standard medical therapy for 6 months or longer and experience discomfort or who are otherwise dissatisfied with GERD symptoms.
- Subjects with a GERD condition that in the opinion of the PI justifies a minimally invasive reversible procedure prior to attempting a more drastic procedure such as a gastric bypass.
- Subject has exhibited excessive lower esophageal acid exposure during 24-hour pH-metry of antisecretory therapy performed within 6 months of screening visit; pH < 4 for > 6% of total time.
- Subject has a resting LES end expiratory pressure ≥ 5mmHg on manometry performed within 6 months of enrollment.
- Subject has no esophagitis or esophagitis ≤ Grade C (LA classification) on upper endoscopy within 6 months of enrollment.
- Subject has esophageal body contraction amplitude > 30 mmHg for >30% of swallows and > 30% peristaltic contractions on manometry.
- Subject has signed the informed consent form and is able to adhere to study visit schedule.
Exclusion Criteria:
- Subject has any non-GERD esophageal motility disorders.
- Subject has evidence of obstruction or stricture in the gastric sleeve by a barium swallow and endoscopy.
- Subject has any significant multisystem diseases.
- Subject has an autoimmune or a connective tissue disorder (e.g. scleroderma, dematomyositis, Calcinosis-Raynaud's-Esophagus Sclerodactyly Syndrome (CREST), Sjogren's Syndrome, Sharp's Syndrome) requiring therapy in the preceding 2 years.
- Subject has Barrett's epithelium (> M2; >C1) or any grade of dysplasia.
- Subject has a hiatal hernia larger than 3 cm.
- Subject has a body mass index (BMI) greater than 35 kg/m2.
- Subject has Type 1 Diabetes Mellitus
- Subject has uncontrolled Type 2 Diabetes Mellitus (T2DM) defined as HbA1c >9.5 in the previous 6 months, or has T2DM for > 10 years.
- Subject has a history of suspected or confirmed esophageal or gastric cancer.
- Subject has esophageal or gastric varices.
- Subject has significant cardiac arrhythmia or ectopy or significant cardiovascular disease.
- Subject has an existing implanted electrical stimulator (e.g., pacemaker, AICD).
- Subject requires chronic anticoagulant therapy.
- Subject has dysphagia or esophageal peptic stricture, excluding Schatzki's ring.
- Subject of child-bearing potential who is pregnant or intends to become pregnant during the trial period.
- Subject is currently enrolled in other potentially confounding research.
- History of any malignancy in the last 2 years.
- Subject has any condition that, at the discretion of the investigator, would preclude participation in the trial.
- Weight change of +/- 10% of the EWL (Excess Weight Loss) in the 3 months prior to enrollment.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：非ランダム化
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Electrical Stimulation Therapy
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他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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The incidence and severity of any complications that are associated with the investigational stimulation device throughout the follow-up period.
時間枠：up to 12 month follow-up
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up to 12 month follow-up
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Efficacy - Disease specific quality of life
時間枠：Baseline, 6 and 12 month follow up
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The change in patient's GERD-HRQL, where applicable, from baseline (as measured while off PPI) .
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Baseline, 6 and 12 month follow up
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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pH-monitoring
時間枠：Baseline, 6 and 12 month FU
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The change in baseline pH values of % 24-hour esophageal pH< 4.0 and number of reflux events >1minute and >5 minute duration with the same on-stimulation pH parameters at 6 months and at 12 months.
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Baseline, 6 and 12 month FU
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Questionnairres, symptom diary
時間枠：baseline, 6 and 12 month FU
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Change in symptoms frequency and severity at 6 months vs. baseline and at 12 months vs. baseline as measured by patient symptom diary, structured GI questionnaire, and patients quality of life measured by SF-12.
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baseline, 6 and 12 month FU
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Anti-secretory medication use
時間枠：Baseline, 6 and 12 month FU
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Change in anti-secretory medication use as evaluated during the two weeks prior to the 6 mo and 12 mo follow up compared to baseline.
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Baseline, 6 and 12 month FU
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HR-manometry
時間枠：Baseline, 6 and 12 month FU
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Change in LES end expiratory pressure (LESPpre) and the on-stimulation LES end expiratory pressure (LESPpost) at 6 months and 12 months in mmHg.
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Baseline, 6 and 12 month FU
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2014年7月1日
一次修了 (予想される)
2016年1月1日
研究の完了 (予想される)
2016年2月1日
試験登録日
最初に提出
2014年8月4日
QC基準を満たした最初の提出物
2014年8月6日
最初の投稿 (見積もり)
2014年8月7日
学習記録の更新
投稿された最後の更新 (見積もり)
2014年8月7日
QC基準を満たした最後の更新が送信されました
2014年8月6日
最終確認日
2014年8月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。