Clinical trial NCT05938439: Evaluation of the Performance of MAgnetic Gastrointestinal Universal Septotome for Treatment of Candy Cane Syndrome
Official title: Evaluation of the Performance of MAgnetic Gastrointestinal Universal Septotome for Treatment of Candy Cane Syndrome
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Blind Loop Syndrome Postoperative
Candy Cane Syndrome
Keywords: candy cane syndrome
therapeutic endoscopy
steptotomy
Lead sponsor: Erasme University Hospital
Sponsor class: OTHER
Collaborators: name: Brussel Medical Device Center (BMDC)
First posted: 2023-07-10
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Safety related to the number of adverse event
timeFrame: During procedure (operative day) ; at 14 days of follow-up ; at 28 days of follow-up ; at 3 months of follow-up
measure: Performance on symptoms evolution
timeFrame: 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
measure: Performance on symptoms evolution
timeFrame: 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
measure: Performance on symptoms evolution
timeFrame: 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
Secondary outcomes:
measure: Safety : adverse event at mid and long term
timeFrame: After 3 months of implantation
measure: Safety : unplanned interventions
timeFrame: Within the year following device placement
measure: Efficacy : patient's satisfaction with the therapy
timeFrame: At 3 and 12 months of follow-up
measure: Efficacy : change in quality of life
timeFrame: At 28 days, 3 months and 12 months of follow-up
measure: Efficacy : dysphagia evolution
timeFrame: At 14 and 28 days, and at 3 and 12 months of follow-up
measure: Efficacy : dysphagia evolution
timeFrame: At 14 and 28 days, and at 3 and 12 months of follow-up
measure: Efficacy : weight evolution
timeFrame: At 14 and 28 days, and at 3 and 12 months of follow-up
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: Hôpital Universitaire de Bruxelles - Hôpital Erasme
Study officials:
References:
citation: 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.