A Comparison of Narrow Band Imaging (NBI) and Standard Visible White Light Laparoscopy for the Detection of Endometriosis

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Olympus America, Inc
Lutheran General Hospital, Park Ridge, IL
Information provided by (Responsible Party):
Kathy J. Helzlsouer, Mercy Medical Center
ClinicalTrials.gov Identifier:
NCT01464775
First received: September 9, 2011
Last updated: January 6, 2014
Last verified: January 2014
  Purpose

Endometriosis is a relatively common chronic gynecological condition that affects approximately 10% of all women of reproductive age. It is a pelvic inflammatory disease that is characterized by the presence of endometrial glands and stroma outside of the uterine cavity. Typical symptoms of endometriosis include dysmenorrhea, pelvic pain, and infertility; the severity of pain associated with this disease often leads to a considerable decrease in quality of life.

The standard treatment for severe pelvic pain and infertility is to surgically remove endometriotic areas. Identifying all endometriotic lesions is paramount to "optimal endometriosis debulking." The inability to see all endometriosis lesions has been thought to be a factor for patients with little or no relief following surgery. Using the Narrow Band Imaging (NBI) method has the potential to improve visualization of endometriosis lesions, assist in debulking and thus, result in improved clinical outcomes.

NBI is a technique that uses a specific narrow wavelength of light to change the normal color contrasts of the endoscopic image and improve detection of neovascularization, which is the pathological feature of endometriosis for both superficial and deeper vascularization. This type of imaging has the potential to offer improved discrimination of lesions, increasing diagnostic yield as well as resulting in more complete debulking.

This study is designed to determine the degree to which NBI improves the detection and diagnosis of endometriosis lesions. Data collected during the study will be used to test the hypothesis that the use of NBI will improve the detection and diagnosis of endometriotic lesions at the time of laparoscopy compared to standard visible white light examination. Furthermore, this study will also determine the impact of the use of NBI compared to use of white light examination on reported severity of pain at 6-weeks, 3-months, and 6 months following surgery.

Hypotheses:

The use of NBI in addition to white light examination will improve the diagnostic yield of endometriotic lesions at the time of laparoscopy compared to only using white light examination.

The use of NBI in addition to white light examination will improve the sensitivity of detecting endometriotic lesions and reduce false positives at laparoscopy compared to only using white light examination.

Secondarily, the use of NBI will be associated with a greater reduction in pain at the 6-week, 3-month, and 6-month follow-up compared to the use of white light examination alone because of improved lesion identification and debulking.


Condition Intervention
Endometriosis
Other: NBI
Other: White light

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Diagnostic Yield of Narrow Band Imaging (NBI) and Standard Visible White Light Laparoscopy for the Detection of Endometriosis

Resource links provided by NLM:


Further study details as provided by Mercy Medical Center:

Primary Outcome Measures:
  • Diagnostic Yield [ Time Frame: Day of surgery, day 1 ] [ Designated as safety issue: No ]
    Diagnostic yield in this study is defined as the percentage of patients undergoing the surgical procedure who are diagnosed, based on pathology, with endometriosis. It is hypothesized that the diagnostic yield will be statistically and significantly higher among patients randomized to white light/NBI compared to those randomized to white light/white light.

  • Sensitivity [ Time Frame: Day of surgery, day 1 ] [ Designated as safety issue: No ]
    Sensitivity in this study is defined as the percentage of lesions biopsied that are determined, based on pathology, to be endometriotic divided by the number of total lesions biopsied. It is hypothesized that the sensitivity for detecting endometriotic lesions will be higher in the white light/NBI arm compared to the white light/white light arm.


Secondary Outcome Measures:
  • Self-reported pain [ Time Frame: 6 weeks, 3 months and 6 months [post surgery] ] [ Designated as safety issue: No ]
    At each of the follow-up time points (6 weeks, 3 months, 6 months), questionnaires will be administered to the patient in order to quantify existing pain and to assess change in pain from baseline. Measurement tools for pain include a 10 centimeter visual analogue scale and the validated Endometriosis Health Profile (EHP-30).


Estimated Enrollment: 170
Study Start Date: September 2011
Estimated Study Completion Date: January 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NBI
Women will be randomized to white light/NBI versus white light/white light laparoscopy
Other: NBI
Women will be randomized to white light/NBI versus white light/white light laparoscopic surgery
Other Name: Narrow band imaging
Active Comparator: White light
Women will be randomized to white light/NBI versus white light/white light laparoscopy
Other: White light
Women will be randomized to white light/NBI versus white light/white light laparoscopic surgery

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 49 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women 18 years of age or older
  • Women of reproductive age (less than 50 years) undergoing diagnostic laparoscopy for suspected endometriosis.
  • Willingness to provide informed consent

Exclusion Criteria:

  • Pregnancy
  • General health issues that the physician determines would make laparoscopy unsafe.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01464775

Locations
United States, Illinois
Lutheran General Hospital
Park Ridge, Illinois, United States, 60540
United States, Maryland
Mercy Medical Center
Baltimore, Maryland, United States, 21202
Sponsors and Collaborators
Mercy Medical Center
Olympus America, Inc
Lutheran General Hospital, Park Ridge, IL
Investigators
Principal Investigator: Kathy Helzlsouer, M.D., M.H.S. Mercy Medical Center
Principal Investigator: Fermin Barrueto, M.D., FACOG Mercy Medical Center
  More Information

Publications:

Responsible Party: Kathy J. Helzlsouer, Director, Prevention and Research Center, Mercy Medical Center
ClinicalTrials.gov Identifier: NCT01464775     History of Changes
Other Study ID Numbers: MMC-2011-57
Study First Received: September 9, 2011
Last Updated: January 6, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Mercy Medical Center:
Endometriosis
Laparoscopy
Narrow Band Imaging

Additional relevant MeSH terms:
Endometriosis
Genital Diseases, Female

ClinicalTrials.gov processed this record on April 15, 2014