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

Endoscopic Cardiac Band Ligation (CLEAR) Without Sleeve Stenosis for the Management of Refractory GERD After Laparoscopic Sleeve Gastrectomy (LSG)

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.

Study Overview

• Status: Withdrawn
• Conditions: GERD; Bariatric Surgery; Laparoscopic Sleeve Gastrectomy
• Intervention / Treatment: Procedure: Cardia Band Ligation

Detailed Description

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. GERD symptoms are common in the obese population with data showing weekly GERD symptoms in 34.6% and erosive esophagitis 26.9% in people with BMI > 30 Kg/m^2. Reflux is associated with complications such as esophagitis, Barrett's Esophagus and ultimately esophageal adenocarcinoma. Presently, bariatric interventions are the only sustainable method to address morbid obesity and its resulting comorbidities. There are endoscopic and surgical bariatric interventions. Bariatric surgery has been shown to be an effective and efficient means of achieving significant weight loss in obese individuals. 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. LSG can increase the incidence of GERD, which may be explained from the changes in the angle of His and by increasing intragastric pressure. Pharmacological therapy with proton pump inhibitors (PPI), H2 blockers and lifestyle changes are first line forms of treatment utilized to control the symptoms related to GERD. However, patients who use pharmacological treatment experience reduction in quality of life and seek alternative options. Refractory GERD is defined by lack of symptom control on maximum dose of PPI therapy. Moreover, due to the anatomical changes associated with bariatric surgeries, the traditional surgical and endoscopic techniques (TIF, Nissen Fundoplication) used to treat GERD in the general population are not suitable for these patients. With the current trend of an increase of bariatric surgery and thus GERD that arises after these surgeries, new innovative techniques to treat GERD are needed, especially in PPI averse or non-responsive patients. 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 will perform CLEAR by placing 4 bands at the GEJ. The investigators hypothesized that CLEAR can be a safe and efficient intervention to improve post bariatric GERD.

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.
• HREM showing marked ineffective esophageal motility (defined by ≥ 5 weak or failed swallows per Chicago Classification v 3.0), esophagogastric outflow obstruction (EGJOO) or achalasia.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CLEAR; Patients with GERD post LSG will undergo CLEAR (cardia band ligation).	Procedure: Cardia Band Ligation; Patients will undergo cardia band ligation at the level of the GEJ.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean change on the percentage of acid exposure time (% AET)	Changes in acid exposure time from baseline.	Baseline and 6 months
Safety of CLEAR procedure as assessed by treatment-related adverse events	Assess overall safety (treatment-related adverse events) of CLEAR procedure defined by the ASGE-Lexicon classification.	Up to 6 months
Rate of dysphagia post CLEAR	Percentage of patients who develop dysphagia of any grade, associated with esophageal or gastric cardia stricture requiring dilation after CLEAR procedure.	6-12 months
PPI discontinuation	Percentage of patients who no longer require PPI at 6 months post CLEAR.	6 months
PPI discontinuation	Percentage of patients who no longer require PPI at 12 months post CLEAR.	12 months
Treatment failure	Defined as less than 50% improvement in GERD HQRL/RSI score or pH monitoring.	6 months

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Investigators: Principal Investigator: Olaya I Brewer Gutierrez, Johns Hopkins University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2021
• Primary Completion (Anticipated): September 1, 2021
• Study Completion (Anticipated): September 1, 2021

Study Registration Dates

• First Submitted: February 23, 2021
• First Submitted That Met QC Criteria: February 23, 2021
• First Posted (Actual): February 25, 2021

Study Record Updates

• Last Update Posted (Actual): September 28, 2021
• Last Update Submitted That Met QC Criteria: September 22, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: GERD; LSG; Antireflux procedure; CLEAR
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastroesophageal Reflux
• Other Study ID Numbers: IRB00277820

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No