Clinical trial NCT01025739: Evaluation of the Safety and Effectiveness of Tailored Transoral Incisionless Fundoplication (TIF) Using EsophyX for the Treatment of GERD
Official title: Phase II Study of Evaluation of the Safety and Effectiveness of Tailored Transoral Incisionless Fundoplication (TIF) Using EsophyX for the Treatment of GERD
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Gastroesophageal Reflux Disease (GERD)
Keywords: Gastroesophageal Reflux Disease (GERD)
EsophyX
Lead sponsor: University of Alberta
Sponsor class: OTHER
Collaborators: name: AHS Cancer Control Alberta
First posted: 2009-12-03
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Objectives of the Study:

The primary objective of this study is to evaluate the relative merits, safety and effectiveness of the tailored TIF2 procedure in treating GERD patients who have persistent GERD symptoms despite PPI therapy.

The secondary objective of the study is to evaluate the effectiveness of the tailored TIF procedure in restoring the antireflux barrier and eliminating GE reflux.

Type of Study:

Prospective, non-randomized, uncontrolled Study Duration 12 months Number of Patients 20

Inclusion Criteria:

Age 18-70 years, on daily PPIs for \> 6 months, persistent GERD symptoms despite PPI therapy, anatomic disruption of the gastroesophageal valve to a Hill Grade II-III, evidence of one of the following while on PPI therapy: (1) erosive esophagitis (erosions or ulcerations during endoscopy); (2) abnormal ambulatory pH study; or (3) biopsy confirmed changes characteristic of reflux esophagitis; acceptable esophageal motility (by either manometry or video esophagogram), hiatal hernia no larger than 2 cm, patient willing to cooperate with post-operative dietary recommendations and assessment tests, signed informed consent

Exclusion Criteria:

BMI \> 40, hiatal hernia \> 2 cm, esophagitis grade D, esophageal ulcer, fixed esophageal stricture, gastric motility disorders, previous splenectomy, pregnancy (female), immunosuppression, ASA \> 2, portal hypertension and/or varices, history of previous resective gastric or esophageal surgery, cervical spine fusion, Zenker's diverticulum, esophageal epiphrenic diverticulum, achalasia, scleroderma or dermatomyositis, eosinophilic esophagitis, or cirrhosis, active gastro-duodenal ulcer disease, gastric outlet obstruction or stenosis, gastroparesis or delayed gastric emptying, coagulation disorders

Interventions:

Treatment: Tailored transoral incisionless fundoplication (TIF2) using EsophyX system with SerosaFuse fasteners (EndoGastric Solutions, Inc., Redmond, WA, USA)

Evaluation Criteria:

Primary Outcome Measure 24 hour pH impedance study: change in Johnson DeMeester scores; GERD-HRQOL scores Secondary Outcome Measures PPI usage, GERD symptoms at 6 and 12 months vs. baseline off PPI's, total number of reflux episodes, and Symptom Association Probability while off PPI.

Safety: Adverse events will be mapped to standard terms and reported.


Eligibility criteria: Inclusion Criteria:

* Age 18-70 years
* On daily PPIs for \> 6 months
* Persistent GERD symptoms despite PPI therapy
* Anatomic disruption of the gastroesophageal valve to a Hill Grade II-III
* Evidence of one of the following while on PPI therapy:

  * Erosive esophagitis (erosions or ulcerations during endoscopy)
  * Abnormal ambulatory pH study
  * Biopsy confirmed changes characteristic of reflux esophagitis
* Acceptable esophageal motility (by either manometry or video esophagogram)
* Hiatal hernia no larger than 2 cm
* Patient willing to cooperate with post-operative dietary recommendations and assessment tests
* Signed informed consent

Exclusion Criteria:

* BMI \> 40
* Hiatal hernia \> 2 cm
* Esophagitis grade D
* Esophageal ulcer
* Esophageal stricture
* Esophageal motility disorder
* Prior splenectomy
* Pregnancy or plans for pregnancy in the next 12 months (in females)
* Immunosuppression
* ASA \> 2
* Portal hypertension and/or varices
* History of previous resective gastric or esophageal surgery, cervical spine fusion, Zenker's diverticulum, esophageal epiphrenic diverticulum, achalasia, scleroderma or dermatomyositis, eosinophilic esophagitis, or cirrhosis
* Active gastro-duodenal ulcer disease
* Gastric outlet obstruction or stenosis
* Gastroparesis or delayed gastric emptying confirmed by solid-phase gastric emptying study if patient complains of postprandial satiety during assessment
* Coagulation disorders

Primary outcomes:
measure: 24 hour pH impedance study: change in Johnson DeMeester scores; GERD-HRQOL scores
timeFrame: 1, 3, 6, 12 month
Secondary outcomes:
measure: PPI usage, GERD symptoms at 6 and 12 months vs. baseline off PPI's, total number of reflux episodes, and Symptom Association Probability while off PPI. Safety: Adverse events will be mapped to standard terms and reported.
timeFrame: 1 day; 1 week; 1, 3, 6, 12 month
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: CAMIS, Royal Alexandra Hospital
state: Alberta
Study officials:
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