Blind Loop Syndrome Postoperative, Candy Cane Syndrome
Conditions
Keywords
candy cane syndrome, therapeutic endoscopy, steptotomy
Brief summary
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.
Interventions
DEVICEMAGUS 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 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.
Sponsors
Brussel Medical Device Center (BMDC)
Erasme University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety related to the number of adverse event | During procedure (operative day) ; at 14 days of follow-up ; at 28 days of follow-up ; at 3 months of follow-up | All adverse events device or procedure related will be captured |
| Performance on symptoms evolution | 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 | Evolution of pain will be assessed on a visual analog scale from 0 (= no symptom) to 10 (= severe symptom) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy : patient's satisfaction with the therapy | At 3 and 12 months of follow-up | Scored by a visual analogue scale from 0 (= not satisfied at all) to 5 (=very satisfied) |
| Efficacy : change in quality of life | At 28 days, 3 months and 12 months of follow-up | Short-Form-12 score. A higher score indicates a better quality of life |
| Safety : adverse event at mid and long term | After 3 months of implantation | All adverse events will be reported |
| Efficacy : weight evolution | At 14 and 28 days, and at 3 and 12 months of follow-up | Weight measurment in kg |
| Efficacy : dysphagia evolution | At 14 and 28 days, and at 3 and 12 months of follow-up | Eckart score from 0 to 12. A higher score indicates more severe pathology. |
| Safety : unplanned interventions | Within the year following device placement | Number of unplanned interventions |
Countries
Belgium
Contacts
Primary ContactPauline Van Ouytsel
Outcome results
None listed