High Resolution Microendoscopy for the Detection of Esophageal Squamous Cell Neoplasia

  • End date
    Dec 30, 2021
  • participants needed
  • sponsor
    Anandasabapathy, Sharmila, M.D.
Updated on 30 January 2021
Madeleine Allman, MPH
Primary Contact
First Hospital of Jilin University (0.0 mi away) Contact
+2 other location


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.


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:
  2. Diagnostic Yield: The number of neoplastic biopsies/total number of biopsies obtained in patients who receive biopsies.
  3. 'Patients saved': # patients who receive no biopsies
  4. Procedure time: Total procedure time in the HRME-LC arm compared to the LC arm.
  5. 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.
  6. 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.

Condition Suspected or Known Squamous Cell Neoplasia, Prior History of Squamous Cell Dysplasia and /or Neoplasia, Prior History of Squamous Cell Dysplasia and /or Neoplasia, Prior History of Squamous Cell Dysplasia and /or Neoplasia, Prior History of Squamous Cell Dysplasia and /or Neoplasia, Prior History of Squamous Cell Dysplasia and /or Neoplasia
Treatment Proflavine, high resolution imaging
Clinical Study IdentifierNCT02029937
SponsorAnandasabapathy, Sharmila, M.D.
Last Modified on30 January 2021


Yes No Not Sure

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
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact


Preferred Language
Other Language
Please verify that you are not a bot.

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider


Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 



Reply by • Private

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note