Clinical trial NCT04771247: Endoscopic Cardiac Band Ligation for the Management of Refractory GERD After Laparoscopic Sleeve Gastrectomy
Official title: Endoscopic Cardiac Band Ligation (CLEAR) Without Sleeve Stenosis for the Management of Refractory GERD After Laparoscopic Sleeve Gastrectomy (LSG)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: GERD
Bariatric Surgery
Laparoscopic Sleeve Gastrectomy
Keywords: CLEAR
Antireflux procedure
LSG
GERD
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2021-02-25
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective, single center, pilot clinical trial
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in GERD-HQRL/RSI score
timeFrame: Baseline and 6 months
measure: Change in pH monitoring
timeFrame: Baseline and 6 months
Secondary outcomes:
measure: Mean change on the percentage of acid exposure time (% AET)
timeFrame: Baseline and 6 months
measure: Safety of CLEAR procedure as assessed by treatment-related adverse events
timeFrame: Up to 6 months
measure: Rate of dysphagia post CLEAR
timeFrame: 6-12 months
measure: PPI discontinuation
timeFrame: 6 months
measure: PPI discontinuation
timeFrame: 12 months
measure: Treatment failure
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Johns Hopkins University
name: Olaya I Brewer Gutierrez
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.