Outcome of Gastric Fundus and Pylorus Botulinum Toxin A Injection

NCT ID: NCT04948177

Last Updated: 2021-07-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 77 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-07-01
• Study Completion Date: 2021-06-01

Brief Summary

Newly, botulinum toxin A application into the stomach has been proposed as a treatment method in obesity. It impacts through acetylcholine receptors located in smooth muscle cells and suppresses stomach motility. This method aims to decrease gastric emptying time and thus to extend the duration of feeling full. This effect of intragastric botulinum toxin A injection (GBI) makes it easier to adhere to dietary prescriptions, which is the cornerstone of any obesity treatment method.

Endoscopic inspections and the complicatedness in literature results, cases that have not succeeded in losing weight after GBI might have pylorus contractility problems. Any deterioration in pylorus activity is recognized to have the potential to influence gastric emptying. In such a case, gastric emptying time would also be altered due to the paralysis of pylorus muscles, which is one of the effect mechanisms of botulinum toxin A.

The pyloric orifice structure may have a crucial role in the success or failure of GBI therapy for obesity treatment.

Detailed Description

The prevalence of obesity has doubled globally in the last four decades to the extent that nearly one-third of the world population is now classified as overweight/obese. Obesity causes adverse impacts on almost every physiological system in the human body and comprises an important public health problem. It is associated with an increased risk of many developing co-morbid conditions, such as diabetes mellitus, cardiovascular disease, several types of cancers, musculoskeletal disorders, and poor mental health.

Current treatment options for patients with obesity include lifestyle intervention, obesity pharmacotherapy, and bariatric surgery. The components of lifestyle intervention involve diet, exercise, and behavior modification and should be recognized as the cornerstone of any obesity treatment method; however, the impact of lifestyle intervention is limited in patients with morbid obesity.

Surgical therapies with laparoscopic approach are accepted as the most effective and persistent obesity-treatment methods, with a significant reduction in complication rates and postoperative recovery. Gastric banding, sleeve gastrectomy, Roux-en-Y gastric bypass, and biliopancreatic diversion are commonly performed bariatric surgical procedures worldwide. But, the idea of scarless methods in which the video-endoscopy device is used as the primary carrier device, expecting to achieve results at least as good as laparoscopic procedures, has significantly developed within the last decade. Additionally, the development of effective and safe, newer endoscopic bariatric procedures provides another adjunctive treatment for patients with obesity who cannot handle this disease with lifestyle modification alone or who is not a candidate for surgical procedures. Endoscopic therapies, such as intra-gastric balloons, duodenojejunal bypass liners such as the EndoBarrier, and endoscopic suturing platforms, have also become proposed alternatives to surgery, considering their minimally-invasive advantages. However, given the lack of long-term data at present, the role of such devices continues to be determined.

Newly, botulinum toxin A application into the stomach has been proposed as a treatment method in obesity. It impacts through acetylcholine receptors located in smooth muscle cells and suppresses stomach motility. This method aims to decrease gastric emptying time and thus to extend the duration of feeling full. This effect of intragastric botulinum toxin A injection (GBI) makes it easier to adhere to dietary prescriptions, which is the cornerstone of any obesity treatment method.

Endoscopic inspections and the complicatedness in literature results, cases that have not succeeded in losing weight after GBI might have pylorus contractility problems. Any deterioration in pylorus activity is recognized to have the potential to influence gastric emptying. In such a case, gastric emptying time would also be altered due to the paralysis of pylorus muscles, which is one of the effect mechanisms of botulinum toxin A.

The pyloric orifice structure may have a crucial role in the success or failure of GBI therapy for obesity treatment.

The present study aims to explore whether there is a correlation between weight loss after GBI and pyloric orifice structure.

Conditions

Obesity

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: RETROSPECTIVE

Study Groups

Group A

Group A: Individuals who had normal pyloric orifice structure;

No interventions assigned to this group

Group B

Group B: Individuals who have abnormal pyloric orifice structure

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

-Class I obese patients and class II obese patients with no comorbidities

Exclusion Criteria

• Patients with type 3-4 hiatal hernia according to flap-valve grading system
• Los Angeles type B-C esophagitis
• Type I-II ulcer
• Malignant or suspected malignant lesion in stomach
• Age <18 or >70
• Patients use drugs affecting gastric contractility and pyrokinesis
• Patients have endocrine system problems (hypothyroidism and Cushing syndrome), active psychiatric disorder were not accepted as a candidate for GBI therapy.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Okan University

OTHER

Sponsor Role: lead

Responsible Party

Murat Ferhat Ferhatoglu

M.D, Asisstant Professor, Assistant Director of Transplantation Clinic

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Okan University

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

56665618-204.01.07A

Identifier Type: -

Identifier Source: org_study_id