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Endoscopic Surgery for Bariatric Revision After Weight Loss Failure

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ClinicalTrials.gov Identifier: NCT01871896
Recruitment Status : Recruiting
First Posted : June 7, 2013
Last Update Posted : July 27, 2020
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

Study Description
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Brief Summary:
Morbid obesity and its associated metabolic diseases are on the rise in the United States. Currently, the best treatment for obesity is bariatric surgery where both roux-en-Y gastric bypass and sleeve gastrectomy offer substantial weight loss. Unfortunately, 20% of patients who undergo bariatric surgery fail to lose enough weight defined as less than 50% of excess body weight loss or regain of weight. For those patients who fail to lose weight after bariatric surgery and have failed maximal medical therapy and diet supervision, the treatment is re-operation and revision. Re-operation of the abdomen carries significant postoperative morbidity and mortality. The investigators propose to use the Apollo OverStitch endoscopic suturing device that has already been approved by the FDA as an option for bariatric surgery revision without having to re-operate on the patient. The investigators believe that the endoscopic technique may be able to provide weight loss without having to re-operate on the patient.

Condition or disease Intervention/treatment Phase
Morbid Obesity Weight Loss Device: Endoscopic Suturing to Create Early Satiety Not Applicable

Detailed Description:

The most effective weight loss procedures in the United States are both roux-en-Y gastric bypass (RYGB) and sleeve gastrectomy (SG)where the majority are performed laparoscopically. Estimated excess body weight loss (EBWL) is >50% at the end of one year. However, nearly 20% of patients fail to meet the estimated EBWL or they may experience weight gain recidivism. The first step is nutritional counseling, medically supervised diets, and medical therapy. Surgery would be for those who still fail to lose weight despite the aforementioned efforts.

It is hypothesized that failure of weight loss for RYGB is gastrojejunostomy (GJ) dilation defined as >2 cm. Surgical treatment would require revision of this dilation. Unfortunately many of these revision procedures cannot be done laparoscopically given dense intra-abdominal adhesions. This will require conversion to an open surgery in a morbidly obese patient thus raising postoperative morbidity and mortality estimated to range between 15%-50%.

The investigators propose to use the endoscopic suturing device designed by Apollo EndoSurgery to decrease the GJ dilation to 5-6 mm thus causing restriction, delayed food transit time, and promote early satiety. These efforts will limit overall caloric intake thereby promoting weight loss.

It is thought that patients with previous SG may have a dilation of their stomach. The investigators propose a pyloric cerclage using the Apollo EndoSurgery suturing device by decreasing the opening of the pylorus thus achieving the same goals that the investigators proposed above with RYGB revision.

Endoscopic procedures are same day procedures with little morbidity and mortality when compared to laparoscopic or open bariatric surgery revision.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Apollo OverStitch for Bariatric Surgery Revision After Weight Loss Failure
Study Start Date : January 2014
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Weight Gain
Patients who previously underwent bariatric surgery who failed to lose the expected weight or regained weight.
 Device: Endoscopic Suturing to Create Early Satiety
Evaluating the efficacy of endoscopic suturing for weight loss.
Other Names:
  • Endoscopic Cerclage
  • Bariatric Surgery Revision
  • Apollo EndoStitch
  • Apollo OverTube


Outcome Measures
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Primary Outcome Measures :
  1. Weight loss [ Time Frame: 2 years ]
    We will track patient's weight after their endoscopic bariatric surgery.


Secondary Outcome Measures :
  1. Resolution of Co-morbidities [ Time Frame: 2 years ]
    We will track the patient's weight loss and see if their obesity-related co-morbidities resolve.

  2. Tolerance [ Time Frame: 2 years ]
    We will be monitoring patient's tolerance to this procedure and evaluate their satisfaction via a short questionnaire.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Previous Roux-En-Y Gastric Bypass (RYGB) or Sleeve Gastrectomy (SG)
  • Failure to lose >50% of their excess body weight after 1 year
  • Failure of weight loss despite maximal medical therapy and medically-supervised diets

Exclusion Criteria:

  • Esophageal Stricture
  • Marginal Ulcer at the gastrojejunostomy anastomosis
  • Non-compliance with bariatric follow-up
  • Gastric ulcers
  • Paraesophageal hernias
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01871896


Contacts
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Contact: Matthew Y Lin, MD 415-476-0972 Matthew.Lin@ucsfmedctr.org

Locations
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United States, California
University of California San Francisco Recruiting
San Francisco, California, United States, 94143
Principal Investigator: Matthew Y Lin, MD         
Principal Investigator: Stanley J Rogers, MD         
Sub-Investigator: Jonathan T Carter, MD         
Sub-Investigator: John P Cello, MD         
Sponsors and Collaborators
University of California, San Francisco
Investigators
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Principal Investigator: Stanley J Rogers, MD University of California, San Francisco
Principal Investigator: Jonathan T Carter, MD University of California, San Francisco
Principal Investigator: John P Cello, MD University of California, San Francisco
Principal Investigator: Matthew Lin, MD University of California, San Francisco
More Information
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Publications:

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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01871896    
Other Study ID Numbers: EndoSurgery
First Posted: June 7, 2013    Key Record Dates
Last Update Posted: July 27, 2020
Last Verified: July 2020
Keywords provided by University of California, San Francisco:
Surgical Endoscopy
Morbid Obesity
Weight Loss
Bariatrics
Surgical Revision
Additional relevant MeSH terms:
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Obesity, Morbid
Body Weight
Weight Loss
Obesity
 Overnutrition
Nutrition Disorders
Overweight
Body Weight Changes