Evaluation of the Performance of MAgnetic Gastrointestinal Universal Septotome for Treatment of Candy Cane Syndrome

Обзор

Candy cane syndrome (CCS) is an adverse event (AE) from gastrectomy or gastric bypass and end-to-side anastomosis to a jejunal loop. It seems to be predominantly mechanical, the afferent blind loop enlarge and becomes preferential passage of food. This food accumulated in the blind loop increase luminal pressure, causing dilatation, early satiety, fullness, pain, reflux, regurgitation, postprandial vomiting, weight loss, and, ultimately, inability to eat, leading to cachexia.Up to now, main treatment is laparoscopic revision which is invasive. Adverse events related this surgical procedure occurred in 13,3% of cases and substantial improvement only in 73.9%. A first clinical study with MAGUS including oesophageal diverticulum (n=2) and CCS (n=14) has been performed to assess safety and feasibility of this new device. MAGUS is an implantable device which is placed endoscopically and which, by using pressure necrosis, entailed the marsupialization of the blind loop in less than 30 days. Substantial improvement was observed in all patient and only 7,1% of patients experience an adverse event possibly related to the device. This study aim therefore to assess the safety and performance of the endoscopic treatment of CCS using a new medical device: MAGUS. This will be a single-center, open-label prospective, safety and performance study on 51 patients with Candy Cane Syndrome (CCS). Patients will be followed for 12 months after the procedure, with an enrolment period of 3 years. After the screening, the following data will be collected and examinations and tests performed : physical Exam, medical history including CCS cause and treatment(s) history, weight, Eckart and dysphagia score, Quality of Life questionnaire (SF 12 and GERD HRQL), Main symptom selection (Nausea, Vomiting/regurgitation or pain), nausea VAS, vomiting, regurgitation VAS, pain VAS, barium swallow X-ray or endoscopic assessment of Candy Cane. Follow-up visits will be performed at 14 days, 28 days, 3 months and 12 months post-procedure.

Вмешательства

• Устройство MAGUS placement
  An upper endoscopy will be performed with the use of fluoroscopy under general anaesthesia with orotracheal intubation. The delivery system will be placed over a guidewire, under fluoroscopy. The main steps are the following: * Placement through the endoscope of a soft guidewire through the upper GI tract; * Insertion of the MAGUS system on the guidewire; * Advancement of the MAGUS system until proximal magnet reach the top of the septum; * Release and placement of the proximal magnet at the bo

Первичные конечные точки

• Safety related to the number of adverse event [Срок оценки: During procedure (operative day) ; at 14 days of follow-up ; at 28 days of follow-up ; at 3 months of follow-up]
• Performance on symptoms evolution [Срок оценки: At baseline ; at 14 days of follow-up ; at 28 days of follow-up ; at 3 months of follow-up ; at 12 months of follow-up]
• Performance on symptoms evolution [Срок оценки: At baseline ; at 14 days of follow-up ; at 28 days of follow-up ; at 3 months of follow-up ; at 12 months of follow-up]
• Performance on symptoms evolution [Срок оценки: At baseline ; at 14 days of follow-up ; at 28 days of follow-up ; at 3 months of follow-up ; at 12 months of follow-up]

Вторичные конечные точки (7)

• Safety : adverse event at mid and long term [Срок оценки: After 3 months of implantation]
• Safety : unplanned interventions [Срок оценки: Within the year following device placement]
• Efficacy : patient's satisfaction with the therapy [Срок оценки: At 3 and 12 months of follow-up]
• Efficacy : change in quality of life [Срок оценки: At 28 days, 3 months and 12 months of follow-up]
• Efficacy : dysphagia evolution [Срок оценки: At 14 and 28 days, and at 3 and 12 months of follow-up]
• Efficacy : dysphagia evolution [Срок оценки: At 14 and 28 days, and at 3 and 12 months of follow-up]
• Efficacy : weight evolution [Срок оценки: At 14 and 28 days, and at 3 and 12 months of follow-up]

Критерии участия

Критерии включения

• Patient is diagnosed with candy cane syndrome based on clinical and endoscopic and/or radiologic assessment
• Patient has at least one of this 3 symptoms associated to CCS: pain, nausea, vomiting, regurgitation
• Patient agrees and is able to comply with the study procedures and provide written informed consent to participate in the study

Критерии исключения

• Refractory stenosis of the UGI proximal to the septum
• Septum height smaller than 2 cm or higher than 8 cm
• Coagulation disorders.

• Previous implantation of a magnetic-sensitive medical device (including active electronic implant, metallic stent, …).
• Dysphagia related to motility disorder
• Planned MRI in the following month (30 days) of intervention
• Condition that could compromise patient safety
• Patient who went through an abdominal surgery less than 8 weeks before implantation of the magnets
• Patient pregnant, breastfeeding or incapacitated
• Patient currently enrolled in another clinical trial

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Бельгия · 1 центр

• Hôpital Universitaire de Bruxelles - Hôpital Erasme — Brussels

Публикации

• Rio-Tinto R, Huberland F, Van Ouytsel P, Delattre C, Dugardeyn S, Cauche N, Delchambre A, Deviere J, Blero D. Magnet and wire remodeling for the treatment of candy cane syndrome: first case series of a new approach (with video). Gastrointest Endosc. 2022 Jun;95(6):1247-1253. doi: 10.1016/j.gie.2021.12.027. Epub 2022 Jan 1. PMID 34979115

Идентификаторы

NCT: NCT05938439 · N2023/021

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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