The Transit Bipartition With the Use of a Metallic Anastomosis Clip and Circular Fundocorporeal Gastroplication

What this study is testing ClinicalTrials.gov NCT07495020 ↗

Description as written by the study sponsor.

This study evaluates a new surgical device - the Metallic Anastomotic Clip (MAC) - for performing a laparoscopic bypass gastroenteroanastomosis with entero-enteric anastomosis (transit bipartition / "dual-path" procedure) in patients with type 2 diabetes mellitus (T2DM) who have overweight or Class I obesity (BMI 25-34.9 kg/m²). Currently, most bariatric and metabolic surgery procedures are only approved for patients with a BMI above 35 kg/m². However, many T2DM patients have BMI less 34.9 kg/m2 and cannot access surgical treatment under existing national guidelines. The transit bipartition procedure addresses this gap by creating a second food pathway from the stomach to the ileum while preserving normal duodenal digestion - producing a strong incretin (GLP-1) effect similar to GLP-1 receptor agonists (e.g., semaglutide), without causing excessive weight loss or requiring lifelong vitamin supplementation. The MAC is a novel compression anastomotic device designed to replace conventional hand-sewn or stapled anastomoses, potentially reducing complications such as anastomotic leak, bleeding, marginal ulcers, and strictures, while also lowering operative costs. Participants will be randomised into three groups. The study will assess metabolic outcomes (T2DM remission, glycaemic control), surgical safety, quality of life, and cost-effectiveness over a follow-up period of 2026-2027.

Treatments tested

• Laparoscopic transit bipartition with Metallic Anastomotic Clip and Circular Fundocorporeal Gastroplication Procedure

  The procedure begans creation circular fundocorporeal gastroplication without gastrectomy. A gastroplication calibrated over a 36F calibration tube using two layer nonabsorbable suture. The mobilisation of great curvature starts 4 cm above the pylorus and gastroplication starts 7 above the pylorus for the creation 3 cm gastro-ileal compression anastomosis using Metallic Anastomosis Clip (MAC) and leave a distance of 4 cm between the distal corner of the anastomosis and the pylorus. Laparoscopical the cecum and the last ileal loop are identified, and the bowel is retrogradely measured, from the ileocecal valve up to a 300 cm far from it, where the gastro-ileal anastomosis will be made. And than leave a distance of 50 cm from gastroileal anastomosis creation entero-enteric compression anastomosis using the Metallic Anastomotic Clip.

• Laparoscopic transit bipartition (gastroenteroanastomosis and entero-enteric anastomosis) use the Metallic Anastomotic Clip and with sleeve gastrectomy Procedure

  A calibrated sleeve gastrectomy ("gastric sleeve") over a 36F calibration tube and , using stapler loads with staples of variable height. This gastric section starts 7 cm above the pylorus in order to accommodate the 3 cm gastro-ileal compression anastomosis using Metallic Anastomosis Clip (MAC) and leave a distance of 4 cm between the distal corner of the anastomosis and the pylorus. Laparoscopical the cecum and the last ileal loop are identified, and the bowel is retrogradely measured, from the ileocecal valve up to a 300 cm far from it, where the gastro-ileal anastomosis will be made. And than leave a distance of 50 cm from gastroileal compression anastomosis creation entero-enteric compression anastomosis using the Metallic Anastomotic Clip.

• laparoscopic duodenal transit bipartition using the Metallic Anastomotic Clip with circular fundocorporeal gastroplication without gastrectomy Procedure

  The procedure begans creation circular fundocorporeal gastroplication without gastrectomy. A gastroplication calibrated over a 36F calibration tube using two layer nonabsorbable suture. The mobilisation of great curvature and gastroplication starts 4 above the pylorus. The single 3 cm size duodeno-ileal compression anastomosis by use Metallic Anastomosis Clip (MAC) creation post-pyloric at the first duodenal portion (anterior side).