Clinical trial NCT02029937: High Resolution Microendoscopy for the Detection of Esophageal Squamous Cell Neoplasia
Official title: High Resolution Microendoscopy for the Detection of Esophageal Squamous Cell Neoplasia: A Randomized, Multicenter Trial of Accuracy, Yield, and Clinical Impact
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Suspected or Known Squamous Cell Neoplasia
Prior History of Squamous Cell Dysplasia and /or Neoplasia
Keywords: Squamous cell neoplasia
Proflavine
Lugol's chromoendoscopy
Lead sponsor: Anandasabapathy, Sharmila, M.D.
Sponsor class: INDIV
Collaborators: name: William Marsh Rice University
name: Baylor College of Medicine
First posted: 2014-01-08
Enrollment: 1300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The overall objective of this multicenter trial is to determine whether the use of a low-cost, high-resolution microendoscope during diagnostic upper endoscopy can improve the efficiency and accuracy of endoscopic screening for esophageal squamous cell neoplasia. This is a multicenter clinical trial of a novel technology, a miniaturized, lower cost (\< $3, 500) microscope device which can be used during upper endoscopy to image the gastrointestinal epithelium. This high-resolution microendoscope (HRME) was developed by our collaborators at RICE University and provides \>1000X magnified images of the esophageal mucosa.

Detailed description: Our central hypothesis is that HRME can improve the efficiency and clinical impact of endoscopic screening and surveillance of esophageal squamous cell neoplasia by providing in-vivo optical biopsies comparable to standard histology. Specifically, HRME will allow more detailed evaluation of Lugol's abnormal areas, allowing selective biopsy or removal of neoplastic mucosa. We hypothesize that this will improve the accuracy and diagnostic yield of mucosal sampling.

We also hypothesize the HRME will provide additional, more accurate information regarding the presence of neoplasia that will impact upon the physician's decision to obtain a mucosal biopsy or perform endoscopic therapy (endoscopic mucosal resection or ablation). This could potentially minimize the number of unnecessary biopsies and enable the physician to perform endoscopic therapy at the time of the initial examination, rather than delaying endoscopic treatment to another procedure following pathologic confirmation of the initial biopsies.

Primary Aims:

1. To compare the efficiency of HRME + Lugol's chromoendoscopy (HRME + LC) to that of Lugol's chromoendoscopy alone (LC) for the diagnosis of esophageal squamous cell neoplasia. Efficiency will be defined as:

   1. Diagnostic Yield: The number of neoplastic biopsies/total number of biopsies obtained in patients who receive biopsies.
   2. 'Patients saved': # patients who receive no biopsies
   3. Procedure time: Total procedure time in the HRME-LC arm compared to the LC arm.
2. To prospectively determine the potential clinical impact of HRME + Lugol's chromoendoscopy (HRME-LC) to Lugol's Chromoendoscopy (LC) by determining if HRME changes the decision to perform endoscopic therapy (endoscopic mucosal resection or ablation) or perform a mucosal biopsy.
3. To prospectively compare the performance characteristics of HRME-LC to LC for the prediction of squamous esophageal neoplasia in flat mucosa and mucosal lesions using histopathology as the gold standard:

   (a) To determine the sensitivity, specificity, positive and negative predictive value for the identification of neoplasia on a per biopsy and per patient analysis
4. To determine the cost-effectiveness of HRME-LC to LC alone for the endoscopic screening and surveillance of esophageal squamous neoplasia in the US and China.

Eligibility criteria: Inclusion Criteria:

All inclusive outpatients undergoing routine (standard of care) Lugol's chromoendoscopic evaluation for suspected or known squamous cell neoplasia will be enrolled as well as any outgoing patients referred to the clinic with any prior history of squamous cell dysplasia and/or neoplasia will also be considered eligible as they will serve as study population for the surveillance group.

Exclusion Criteria:

* Allergy or prior reaction to the fluorescent contrast agent proflavine
* Patients who are unable to give informed consent
* Known advanced squamous cell carcinoma of the distal esophagus, or dyplastic/suspected malignant esophageal lesion greater than or equal to 2cm in size not amenable to endoscopic therapy
* Patient unable to undergo routine endoscopy with biopsy:
* women who are pregnant or breastfeeding
* prothrombin time greater than 50% of control; PTT greater than 50 sec, or INR greater than 2.0
* inability to tolerate sedated upper endoscopy due to cardio-pulmonary instability or other significant medical issues

Primary outcomes:
measure: Comparison of the efficiency of HRME+Lugol's chromoendoscopy (HRME+LC) to that of Lugol's chromoendoscopy alone (LC) for the diagnosis of esophageal squamous cell neoplasia.
timeFrame: 1 day
Secondary outcomes:
measure: Determination whether HRME changes the decision to perform endoscopic therapy or perform a mucosal biopsy
timeFrame: 1 day
Other outcomes:
measure: Comparison of the performance characteristics of HRME to LC for the prediction of squamous esophageal neoplasia using histopatholgy as the gold standard. The cost-effectiveness of HRME-LC to LC alone.
timeFrame: 1 day
Locations:
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Changchun
country: China
facility: First Hospital of Jilin University
state: Jilin
city: Beijing
country: China
facility: Cancer Institute and Hospital, Chinese Academy of Medical Sciences (CICAMS)
Study officials:
affiliation: Baylor College of Medicine
name: Sharmila Anandasabapathy, MD
role: PRINCIPAL_INVESTIGATOR
References: