Endoscopic Suture Gastroplasty (ESG) for Treatment of Obese Patients With Endometrial Cancer

Inclusion criteria

• Women with endometrial cancer scheduled for hysterectomy with a curative intent
• Age 21-75
• BMI ≥ 30
• Willingness to undergo E-ESG and lifestyle modifications program
• Willingness to comply with the substantial lifelong dietary restrictions required by the procedure
• Willingness to follow protocol requirements, including signed informed consent, routine follow-up schedule, completing laboratory tests, and completing diet counseling
• Residing within a reasonable distance from the investigator's office and able to travel to the investigator to complete all routine follow- up visits
• Ability to give informed consent

Exclusion criteria

• History of foregut or gastrointestinal (GI) surgery (except uncomplicated cholecystectomy or appendectomy)
• Prior gastrointestinal surgery with sequelae, i.e., obstruction, and/or adhesive peritonitis or known abdominal adhesions
• Prior open or laparoscopic bariatric surgery
• Prior surgery of any kind on the esophagus, stomach, or any type of hiatal hernia surgery
• Any inflammatory disease of the gastrointestinal tract including severe (LA Grade C or D) esophagitis, gastric ulceration, duodenal ulceration, cancer or specific inflammation such as Crohn's disease
• Potential upper gastrointestinal bleeding conditions such as esophageal or gastric varices, congenital or acquired intestinal telangiectasis, or other congenital anomalies of the gastrointestinal tract such as atresia or stenoses
• Gastrointestinal stromal tumors, history of premalignant gastric lesions (advanced atrophic gastritis), history of familial and non-familial adenomatous syndromes
• A gastric mass or gastric polyps \> 1 cm in size
• A hiatal hernia \> 4 cm of axial displacement of the z-line above the diaphragm or severe or intractable gastro-esophageal reflux symptoms
• A structural abnormality in the esophagus or pharynx such as a stricture or diverticulum that could impede passage of the endoscope
• Achalasia or any other severe esophageal motility disorder
• Severe coagulopathy
• Subjects with any serious health condition unrelated to their weight that would increase the risk of endoscopy
• Motility disorders of the GI tract such as gross esophageal motility disorders, gastroparesis, or intractable constipation
• Hepatic insufficiency or cirrhosis
• Use of an intragastric device prior to this study due to the increased thickness of the stomach wall preventing effective suturing
• Active psychological issues preventing participation in a life-style modification program as determined by a psychologist
• Patients unwilling to participate in an established medically supervised diet and behavior modification program, with routine medical follow-up
• Patients who are unable or unwilling to take prescribed proton pump inhibitor medication
• Patients receiving daily prescribed treatment with high dose aspirin (\> 80 mg daily), anti-inflammatory agents, anticoagulants, or other gastric irritants
• Patients who are pregnant or breast-feeding
• Subjects with Severe cardiopulmonary disease or other serious organic disease which might include known history of coronary artery disease, Myocardial infarction within the past 6 months, poorly controlled hypertension, required use of NSAIDs
• Subjects taking medications on specified hourly intervals that may be affected by changes to gastric emptying, such as anti-seizure or anti-arrhythmic medications
• Subjects who are taking corticosteroids, immunosuppressants, and narcotics
• Subjects who are taking diet pills
• Symptomatic congestive heart failure, cardiac arrhythmia, or unstable coronary artery disease
• Pre-existing respiratory disease such as moderate or severe chronic obstructive pulmonary disease (COPD) requiring steroids, pneumonia, or cancer
• Diagnosis of autoimmune connective tissue disorder (e.g., lupus, erythematosus, scleroderma) or immunocompromised
• Specific diagnosed genetic disorder such as Prader Willi syndrome
• Eating disorders including night eating syndrome (NES), bulimia, binge eating disorder, or compulsive overeating
• Known history of endocrine disorders affecting weight such as uncontrolled hypothyroidism