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A Comparison of Narrow Band Imaging (NBI) and Standard White Light Laporoscopy to Detect Endometriosis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01464775
First Posted: November 4, 2011
Last Update Posted: January 22, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Olympus America, Inc.
Lutheran General Hospital, Park Ridge, IL
Information provided by (Responsible Party):
Kathy J. Helzlsouer, Mercy Medical Center
  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
Intervention Model: Parallel Assignment
Masking: None (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 Kathy J. Helzlsouer, Mercy Medical Center:

Primary Outcome Measures:
  • Diagnostic Yield [ Time Frame: Day of surgery, day 1 ]
    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 ]
    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] ]
    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).


Enrollment: 156
Study Start Date: September 2011
Study Completion Date: December 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Agic A, Xu H, Finas D, Banz C, Diedrich K, Hornung D. Is endometriosis associated with systemic subclinical inflammation? Gynecol Obstet Invest. 2006;62(3):139-47. Epub 2006 May 4. Review.
Barrueto FF, Audlin KM. The use of narrowband imaging for identification of endometriosis. J Minim Invasive Gynecol. 2008 Sep-Oct;15(5):636-9. doi: 10.1016/j.jmig.2008.06.017.
Jones G, Kennedy S, Barnard A, Wong J, Jenkinson C. Development of an endometriosis quality-of-life instrument: The Endometriosis Health Profile-30. Obstet Gynecol. 2001 Aug;98(2):258-64.
Stegmann BJ, Sinaii N, Liu S, Segars J, Merino M, Nieman LK, Stratton P. Using location, color, size, and depth to characterize and identify endometriosis lesions in a cohort of 133 women. Fertil Steril. 2008 Jun;89(6):1632-6. Epub 2007 Jul 26.
Kuroda K, Kitade M, Kikuchi I, Kumakiri J, Matsuoka S, Jinushi M, Shirai Y, Kuroda M, Takeda S. Vascular density of peritoneal endometriosis using narrow-band imaging system and vascular analysis software. J Minim Invasive Gynecol. 2009 Sep-Oct;16(5):618-21. doi: 10.1016/j.jmig.2009.05.006.
Garry R, Clayton R, Hawe J. The effect of endometriosis and its radical laparoscopic excision on quality of life indicators. BJOG. 2000 Jan;107(1):44-54.
Redwine DB. Pelvic endometriosis--the same or different entities in disguise? Fertil Steril. 1998 Sep;70(3):588-9.
Zhou X-H, Obuchowski NA, McClish DK. Statistical Methods in Diagnostic Medicine. New York, NY: John Wiley; 2002.
Abbott J, Hawe J, Hunter D, Holmes M, Finn P, Garry R. Laparoscopic excision of endometriosis: a randomized, placebo-controlled trial. Fertil Steril. 2004 Oct;82(4):878-84.
Jarrell J, Mohindra R, Ross S, Taenzer P, Brant R. Laparoscopy and reported pain among patients with endometriosis. J Obstet Gynaecol Can. 2005 May;27(5):477-85.

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
First Submitted: September 9, 2011
First Posted: November 4, 2011
Last Update Posted: January 22, 2015
Last Verified: January 2015

Keywords provided by Kathy J. Helzlsouer, Mercy Medical Center:
Endometriosis
Laparoscopy
Narrow Band Imaging

Additional relevant MeSH terms:
Endometriosis
Genital Diseases, Female


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