Magnet and wire remodeling for the treatment of candy cane syndrome: first case series of a new approach (with video).

BACKGROUND AND AIMS: Candy cane syndrome (CCS) is an adverse event (AE) from gastrectomy or gastric bypass and end-to-side anastomosis to a jejunal loop. Preferential passage of food to the blind loop induces early satiety, pain, and regurgitation. An endoscopic device that combines 2 magnets and a self-retractable wire was designed to perform progressive septotomy with marsupialization. We evaluated the clinical safety and efficacy of this treatment in CCS. METHODS: Consecutive patients presenting with symptoms associated with CCS after gastrectomy or Roux-en-Y gastric bypass were treated with the MAGUS (Magnetic Gastrointestinal Universal Septotome) system. Weight, dysphagia, pain scores, 12-item Short Form Survey quality of life physical and mental scores, GERD Health-Related Quality of Life, and Eckardt score were measured at baseline and 1 and 3 months postprocedure. Satisfaction with therapy and AEs were monitored during follow-up. RESULTS: Fourteen consecutive patients with CCS were enrolled in the study. Thirteen MAGUS systems migrated within 28 days after achieving uneventful complete septotomy. In 1 patient the magnet had to be collected from the right-sided colon after 1 month. Treatment was completed in a single endoscopy session. Dysphagia score (2 [1-3] vs 1 [1-1], P = .02), pain score (7 [6-8] vs 1 [0-1], P = .002), Eckardt score (5 [3-8] vs 1 [0-2], P = .002), GERD Health-Related Quality of Life score (37 [29-45] vs 8 [6-23], P = .002), and quality of life physical and mental scores were all significantly improved at 3 months. No device or procedure-related serious AEs were observed. One patient died during follow-up from evolution of oncologic disease. CONCLUSIONS: Endoluminal septotomy using a retractable wire and magnet system in CCS is feasible and safe, with rapid improvement of symptoms. (Clinical trial registration number: NCT04480216.).

Magnets and a self-retractable wire for endoscopic septotomies: from concept to first-in-human use.

BACKGROUND: A medical device that allows simple and safe performance of an endoscopic septotomy could have several applications in the gastrointestinal (GI) tract. We have developed such a device by combining two magnets and a self-retractable wire to perform a progressive septotomy by compression of the tissues. We describe here the concept, preclinical studies, and first clinical use of the device for the treatment of symptomatic epiphrenic esophageal diverticulum (EED). METHODS: The MAGUS (MAgnetic Gastrointestinal Universal Septotome) device was designed based on previous knowledge of compression anastomosis and currently unmet needs. After initial design, the feasibility of the technique was tested on artificial septa in pigs. A clinical trial was then initiated to assess the feasibility and safety of the technique. RESULTS: Animal studies showed that the MAGUS can perform a complete septotomy at various levels of the GI tract. In two patients with a symptomatic EED, uneventful complete septotomy was observed within 28 and 39 days after the endoscopic procedure. CONCLUSIONS: This new system provides a way of performing endoluminal septotomy in a single procedure. It appears to be effective and safe for managing symptomatic EED. Further clinical applications where this type of remodeling of the GI tract could be beneficial are under investigation.

In Vivo Validation of a Less Invasive Gastrostimulator.

Gastrointestinal stimulator implants have recently shown promising results in helping obese patients lose weight. However, to place the implant, the patient currently needs to undergo an invasive surgical procedure. We report a less invasive procedure to stimulate the stomach with a gastrostimulator. After attempting fully endoscopic implantation, we more recently focused on a single incision percutaneous procedure. In both cases, the challenges in electronic design of the implant are largely similar. This article covers the work achieved to meet these and details the in vivo validation of a gastrostimulator aimed to be endoscopically placed and anchored to the stomach.

Feasibility of a new bariatric fully endoscopic duodenal-jejunal bypass: a pilot study in adult obese pigs.

This study assessed a new natural orifice transluminal endoscopic surgery (NOTES) bariatric endoscopic procedure in obese adult pigs. This 14-week prospective study compared 6 adult male Yucatan test pigs with baseline mean age 1.5 years to 2 control pigs. The test pigs received a fully endoscopic NOTES-based duodenal-jejunal bypass including measurement of the bypassed limb and creation of a gastrojejunal anastomosis (GJA) using a gastrojejunal lumen-apposing metal stent (GJ-LAMS) at Week 0, placement of a duodenal exclusion device (DED) at Week 2, and endoscopic examinations at Weeks 6 and 10. At Week 14, the pigs were sacrificed for necropsy. All endoscopic procedures were technically successful. By Week 14, the controls had gained a mean 1.1 ± 2.1 kg (+ 1.6%) while the intervention animals lost a mean 6.8 ± 3.9 kg (- 10.5%) since baseline. GJ-LAMS migrations occurred in 3 pigs, two of which also had DED migration and/or partial dislocation. Two other pigs died, one with aberrant splenic vein positioning near the GJA and the other from an unknown cause. An endoscopic bariatric bypass procedure with controlled bypass length was technically successful in all the cases and led to weight loss in test animals. Safety concerns must be further addressed.

Feasibility of Conversion of a New Bariatric Fully Endoscopic Bypass Procedure to Bariatric Surgery: a Porcine Pilot Study.

PURPOSE: Bariatric endoscopic procedures are emerging as alternatives to bariatric surgical procedures. This study aimed to assess if a natural orifice transluminal endoscopic surgery (NOTES) bariatric procedure could be converted to a surgical duodenal-jejunal bypass (DJB) or sleeve gastrectomy (SG). MATERIALS AND METHODS: This 12-week prospective study compared 4 test pigs to 3 control (no procedures) pigs aged 3 months at baseline. The test pigs received a fully endoscopic NOTES-based bypass including measurement of the bypassed limb and creation of a gastrojejunal anastomosis (GJA) using gastrojejunal lumen-apposing metal stents (GJ-LAMS) at Week 0, placement of a duodenal exclusion device (DED) at Week 2, and randomization to DJB or SG surgery at Week 8 with subsequent 4-week follow-up. At Week 12, the pigs were sacrificed and necropsy was performed. RESULTS: Endoscopic procedures were technically successful. One pig did not receive a DED due to early GJ-LAMS migration leading to premature closure of the GJA. At Week 8, all 4 pigs were doing well, and the remaining 3 GJ-LAMS and 3 DEDs were uneventfully endoscopically removed. Two one-anastomosis DJB were performed, and 2 SG were performed, closing in one case the site of the previous GJA. The surgical procedures were technically feasible and uneventful during follow-up. Necropsy assessments showed no local or peritoneal inflammation or abscess and no leakage or fistula. CONCLUSION: An endoscopic bariatric bypass can be transitioned to a one-anastomosis duodenal-jejunal bypass or sleeve gastrectomy, without complications.

First fully endoscopic metabolic procedure with NOTES gastrojejunostomy, controlled bypass length and duodenal exclusion: a 9-month porcine study.

We conducted a pilot study of a potential endoscopic alternative to bariatric surgery. We developed a Natural Orifice Transluminal Endoscopic Surgery (NOTES) gastric bypass with controlled bypass limb length using four new devices including a dedicated lumen-apposing metal stent (GJ-LAMS) and pyloric duodenal exclusion device (DED). We evaluated procedural technical success, weight change from baseline, and adverse events in growing Landrace/Large-White pigs through 38 weeks after GJ-LAMS placement. Six pigs (age 2.5 months, mean baseline weight 26.1 ± 2.7 kg) had initial GJ-LAMS placement with controlled bypass limb length, followed by DED placement at 2 weeks. Technical success was 100%. GJ-LAMS migrated in 3 of 6, and DED migrated in 3 of 5 surviving pigs after mucosal abrasion. One pig died by Day 94. At 38 weeks, necropsy showed 100-240 cm limb length except for one at 760 cm. Weight gain was significantly lower in the pigs that underwent endoscopic bypass procedures compared to expected weight for age. This first survival study of a fully endoscopic controlled bypass length gastrojejunostomy with duodenal exclusion in a growing porcine model showed high technical success but significant adverse events. Future studies will include procedural and device optimizations and comparison to a control group.

Design and Implementation of a Less Invasive Gastrostimulator.

Gastrointestinal stimulator implants have recently shown positive results in helping obese patients lose weight. However, to place the implant, the patient currently needs to undergo an invasive surgical procedure. Our team is aiming for a less invasive procedure to stimulate the stomach with a gastrostimulator. Attempts covered fully endoscopic implantation and, more recently, we have focussed on a single incision laparoscopic procedure. Whatever the chosen implantation solution, the electronic design of the implant system shares many challenges. This paper covers the work achieved to meet these.