A Comparison of Narrow Band Imaging (NBI) and Standard Visible White Light Laparoscopy for the Detection of Endometriosis
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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 |
- 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.
- 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: | October 2013 |
| Estimated Primary Completion Date: | April 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 |
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| Contact: Lisa Gallicchio, Ph.D. | 410-951-7956 | lgallic@mdmercy.com |
| United States, Illinois | |
| Lutheran General Hospital | Recruiting |
| Park Ridge, Illinois, United States, 60540 | |
| Contact: Charles Miller, MD 630-428-2229 Chucks1011@aol.com | |
| Contact: Lisa Maki 630-364-1119 LMaki@charlesemillermd.org | |
| Principal Investigator: Charles Miller, M.D. | |
| United States, Maryland | |
| Mercy Medical Center | Completed |
| Baltimore, Maryland, United States, 21202 | |
| 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: | April 4, 2013 |
| 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 May 16, 2013