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| Name | Class |
|---|---|
| Astana Medical University | OTHER |
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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.
Background:
Type 2 diabetes mellitus (T2DM) is a major global health burden characterised by progressive micro- and macrovascular complications despite pharmacological management. Bariatric and metabolic surgery (BMS) has demonstrated superiority over conservative therapy in achieving durable T2DM remission, primarily through incretin-mediated and weight-independent mechanisms. However, standard BMS indications (BMI ≥35 kg/m²) exclude the majority of T2DM patients who present with overweight or Class I obesity (BMI 25-34.9 kg/m²).
Transit bipartition (the "dual-path" procedure) offers a promising alternative: it preserves the natural duodenal alimentary route while creating an additional gastro-ileal bypass with an entero-enteric anastomosis, thereby stimulating GLP-1 secretion and restoring the incretin effect without the malabsorptive consequences of gastric bypass. This eliminates the need for lifelong micronutrient supplementation.
Device:
The Metallic Anastomotic Clip (MAC) is an authors' proprietary compression anastomotic device developed for laparoscopic creation of bypass gastroenteroanastomosis and entero-enteric anastomosis. The device applies controlled radial compression to achieve tissue approximation and anastomotic healing without sutures or staples. A preliminary pilot study in 10 patients demonstrated technical feasibility and safety.
Study Design:
Prospective, randomised controlled trial (RCT) with three parallel arms:
Group 1: laparoscopic transit bipartition (gastroenteroanastomosis and entero-enteric anastomosis using the Metallic Anastomotic Clip) with circular fundocorporeal gastroplication (without gastrectomy) Group 2: laparoscopic transit bipartition (gastro-ileal anastomosis and entero-enteric anastomosis) using the Metallic Anastomotic Clip with sleeve gastrectomy Group 3: laparoscopic duodenal transit bipartition (single duodenoileal anastomosis) using the Metallic Anastomotic Clip sleeve gastrectomy
Primary Outcomes: HbA1c, fasting glucose, HOMA-IR, remission rate of T2DM (per 2021 ADA/EASD/IFSO consensus criteria) at 12 and 24 months;
Secondary Outcomes:
Anastomotic complication rate (leak, bleeding, stricture, marginal ulcer). BMI, quality of life, operative time, length of hospital stay, morbidity and mortality.
Setting: Surgical Centre of Professor Oral Ospanov, Astana, Kazakhstan. Regulatory: The study will be conducted in accordance with GCP guidelines and the Declaration of Helsinki. The Metallic Anastomotic Clip device will be protected by a utility model patent.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MAC_transit bipartition with circular fundocorporeal gastroplication | Experimental | Group 1: 30 patients with laparoscopic transit bipartition (gastroenteroanastomosis and enteroenterostomy) using the Metallic Anastomotic Clip and with circular fundocorporeal gastroplication without gastrectomy |
|
| MAC_transit bipartition with sleeve gastrectomy | Experimental | Group 2: 30 patients with laparoscopic transit bipartition (gastroenteroanastomosis + enteroenterostomy) use Metallic Anastomotic Clip with sleeve gastrectomy |
|
| MAC_duodenal transit bipartition with circular fundocorporeal gastroplication | Experimental | Group 3: 30 patients with laparoscopic duodenal transit bipartition use Metallic Anastomotic Clip with circular fundocorporeal gastroplication |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| T2DM remission rate | Change % of Glycosylated Hemoglobin. A1C level is below 5.7% - full remisson, a level of 5.7% to 6.4% indicates partial remission , and a level of 6.5% or more indicates diabetes | Baseline, 1, 2, 3 year after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Change of body mass index | The measure is assessing a change of body mass index. Weight (kg) and height (cm) will be combined with the report of measurement by body mass index (BMI) kg/m2 | Baseline, 1, 2, 3 year after surgery |
| Anastomotic complication rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Oral Ospanov | Contact | Astana, Kazakhstan, 010000 | bariatric.kz@gmail.com | |
| Bakhtiyar Yelembayev | Contact | elembaevbaha@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Oral Ospanov, Professor | Astana Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oral Ospanov | Recruiting | Astana | 010000 | Kazakhstan |
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| 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). |
|
leak, bleeding, stricture, marginal ulcer |
| <30 day after surgery, 1, 2, 3 year after surgery |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D009765 | Obesity |
| D050177 | Overweight |
| D010437 | Peptic Ulcer |
| D057868 | Anastomotic Leak |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004378 | Duodenal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D013272 | Stomach Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D005743 | Gastrectomy |
| ID | Term |
|---|---|
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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