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.
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
Refractory stenosis of the UGI proximal to the septum
Septum height smaller than 2 cm or higher than 8 cm
Coagulation disorders.
Dysphagia related to motility disorder
Single group
MAGUS placement
DeviceAn 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 bottom of the septum, pouch side; * Meeting of the distal and proximal magnet on both sides of the septum, by pulling on the delivery system; * Release of the distal magnet and activate the retractable wire; * Insure that wire is not blocked and unblocked it if applicable. Endoscopy and contrast injection will be performed before and after placement to ensure the correct positioning of the magnets.
Safety related to the number of adverse event
All adverse events device or procedure related will be captured
Performance on symptoms evolution
Evolution of pain will be assessed on a visual analog scale from 0 (= no symptom) to 10 (= severe symptom)
Performance on symptoms evolution
Evolution of nausea will be assessed on a visual analog scale from 0 (= no symptom) to 10 (= severe symptom)
Performance on symptoms evolution
Evolution of regurgitations/vomiting will be assessed on a visual analog scale from 0 (= no symptom) to 10 (= severe symptom)
Safety : adverse event at mid and long term
All adverse events will be reported
Safety : unplanned interventions
Number of unplanned interventions
Efficacy : patient's satisfaction with the therapy
Scored by a visual analogue scale from 0 (= not satisfied at all) to 5 (=very satisfied)
Efficacy : change in quality of life
Short-Form-12 score. A higher score indicates a better quality of life
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Erasme University Hospital
Lead sponsor
Brussel Medical Device Center (BMDC)
Collaborator
