Endoscopic Cardiac Band Ligation for the Management of Refractory GERD After Laparoscopic Sleeve Gastrectomy

NCT04771247 | Withdrawn

• 1 other identifier: IRB00277820
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

GERD is a prevalent condition worldwide, estimated to be around 20-30 % in North America. Obesity is rapidly increasing with an estimated prevalence of 66% in the adult population in the United States. Presently, bariatric interventions are the only sustainable method to address morbid obesity and its resulting comorbidities. One of the most common restrictive surgeries includes laparoscopic sleeve gastrectomy (LSG). Although very effective for treating obesity, some of these surgeries might cause deleterious effects regarding GERD, due to anatomical modifications. Refractory GERD is defined by lack of symptom control on maximum dose of PPI therapy. Cardia Band Ligation Anti-reflux (CLEAR) procedure utilizes multiple band ligations at the cardia in a 270-degree fashion, resulting in tissue necrosis and scar formation, narrowing the GE junction and enhancing the flap valve system. The investigators hypothesized that CLEAR can be a safe and efficient intervention to improve post bariatric GERD.

Conditions

GERD; Bariatric Surgery; Laparoscopic Sleeve Gastrectomy

Keywords

CLEAR; Antireflux procedure; LSG; GERD

Outcome Measures

Primary Outcomes (2)

• Change in GERD-HQRL/RSI score

  Change in symptoms assessed by GERD-HQRL/RSI score at 6 months.

  Baseline and 6 months

• Change in pH monitoring

  Change in objective pH monitoring at 6 months.

  Baseline and 6 months

Secondary Outcomes (6)

• Mean change on the percentage of acid exposure time (% AET)

  Baseline and 6 months

• Safety of CLEAR procedure as assessed by treatment-related adverse events

  Up to 6 months

• Rate of dysphagia post CLEAR

  6-12 months

• PPI discontinuation

  6 months

• PPI discontinuation

  12 months

Study Arms (1)

CLEAR

EXPERIMENTAL

Patients with GERD post LSG will undergo CLEAR (cardia band ligation).

Procedure: Cardia Band Ligation

Interventions

Cardia Band Ligation PROCEDURE

Patients will undergo cardia band ligation at the level of the GEJ.

CLEAR

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Obese patients who underwent surgical bariatric weight loss procedures with post-surgical GERD (LSG), not responding to once daily PPI therapy.
• Obese patients who underwent surgical bariatric weight loss procedures with post-surgical GERD (LSG) who respond to maximum therapy with PPI + H2 blocker but are PPI averse or who refuse surgical therapy (conversion to RYGBP).
• Patients older than 18 years and younger than 75 years of age at time of consent.
• Patients able to provide written informed consent on the IRB/EC-approved informed consent form
• Patients willing and able to comply with study requirements for follow-up

You may not qualify if:

• Any patient with no prior surgical bariatric intervention.
• Pre-existing esophageal stenosis/stricture preventing advancement of an endoscope during screening/baseline EGD.
• Esophageal, gastric or duodenal malignancy.
• Severe medical comorbidities precluding endoscopy, or limiting life expectancy to less than 2 years in the judgment of the endoscopist.
• Uncontrolled coagulopathy or inability to be off anticoagulation or anti-platelet medication (ASA, Plavix) for 1 week prior to and 2 weeks after each endoscopy
• Active fungal esophagitis, Grade C or D esophagitis.
• Hiatal hernias \> 2 cm or para-esophageal hernias.
• Known portal hypertension, visible esophageal or gastric varices, or history of esophageal varices.
• General poor health, multiple co-morbidities placing the patient at risk, or otherwise unsuitable for trial participation.
• Pregnant or planning to become pregnant during period of study participation.
• Patient refuses or is unable to provide written informed consent.
• Prior surgical or endoscopic anti-reflux procedure.
• Persistent dysphagia score greater than 0.
• Vomiting more than once a week.
• Biopsy-proven Barrett's esophagus.

Sponsors & Collaborators

• Johns Hopkins University: lead

Related Publications (1)

• Seleem WM, Hanafy AS, Mohamed SI. Endoscopic management of refractory gastroesophageal reflux disease. Scand J Gastroenterol. 2018 Apr;53(4):390-397. doi: 10.1080/00365521.2018.1445775. Epub 2018 Feb 28.

  PMID: 29488430 BACKGROUND

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Olaya I Brewer Gutierrez

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, single center, pilot clinical trial

Study Record Dates

• First Submitted: February 23, 2021
• First Posted: February 25, 2021
• Study Start: September 1, 2021
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2021
• Last Updated: September 28, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share