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

NCT01464775 | Completed Results DMC

• 1 other identifier: MMC-2011-57
• Study Type: interventional
• Target: 167
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Endometriosis

Keywords

Endometriosis; Laparoscopy; Narrow Band Imaging

Outcome Measures

Primary Outcomes (2)

• Diagnostic Yield

  Diagnostic yield in this study is defined as the number 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.

  Day of surgery, day 1

• Sensitivity

  Sensitivity in this study is defined as the number 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.

  Day of surgery, day 1

Secondary Outcomes (1)

• Self-reported Pain

  6 weeks, 3 months and 6 months [post surgery]

Study Arms (2)

Narrow Band Imaging (NBI)

EXPERIMENTAL

Women will be randomized to white light/NBI versus white light/white light laparoscopy

Other: Narrow Band Imaging (NBI)

Standard White Light Laparoscopy

ACTIVE COMPARATOR

Women will be randomized to white light/NBI versus white light/white light laparoscopy

Other: Standard White Light Laparoscopy

Interventions

Narrow Band Imaging (NBI) OTHER

Women will be randomized to white light/NBI versus white light/white light laparoscopic surgery

Also known as: Narrow band imaging

Narrow Band Imaging (NBI)

Standard White Light Laparoscopy OTHER

Women will be randomized to white light/NBI versus white light/white light laparoscopic surgery

Standard White Light Laparoscopy

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Pregnancy
• General health issues that the physician determines would make laparoscopy unsafe.

Sponsors & Collaborators

• Mercy Medical Center: lead
• Olympus America, Inc.: collaborator
• Advocate Lutheran General Hospital: collaborator

Study Sites (2)

Lutheran General Hospital

Park Ridge, Illinois, 60540, United States

Location

Mercy Medical Center

Baltimore, Maryland, 21202, United States

Location

Related Publications (10)

• 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. doi: 10.1159/000093121. Epub 2006 May 4.

  PMID: 16679772 BACKGROUND

• 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.

  PMID: 18722976 BACKGROUND

• 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. doi: 10.1016/s0029-7844(01)01433-8.

  PMID: 11506842 BACKGROUND

• 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. doi: 10.1016/j.fertnstert.2007.05.042. Epub 2007 Jul 26.

  PMID: 17662280 BACKGROUND

• 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.

  PMID: 19835806 BACKGROUND

• 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. doi: 10.1111/j.1471-0528.2000.tb11578.x.

  PMID: 10645861 BACKGROUND

• Redwine DB. Pelvic endometriosis--the same or different entities in disguise? Fertil Steril. 1998 Sep;70(3):588-9. No abstract available.

  PMID: 9757899 BACKGROUND

• Zhou X-H, Obuchowski NA, McClish DK. Statistical Methods in Diagnostic Medicine. New York, NY: John Wiley; 2002.

  BACKGROUND

• 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. doi: 10.1016/j.fertnstert.2004.03.046.

  PMID: 15482763 BACKGROUND

• 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. doi: 10.1016/s1701-2163(16)30531-x.

  PMID: 16100643 BACKGROUND

MeSH Terms

Conditions

Endometriosis

Interventions

Narrow Band Imaging

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Optical Imaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Results Point of Contact

• Title: Dr. Fermin Barrueto
• Organization: MercyMC

fbarrueto@mdmercy.com

410-321-8452

Study Officials

• Kathy Helzlsouer, M.D., M.H.S.

  Mercy Medical Center

  PRINCIPAL INVESTIGATOR

• Fermin Barrueto, M.D., FACOG

  Mercy Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Study Record Dates

• First Submitted: September 9, 2011
• First Posted: November 4, 2011
• Study Start: September 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2014
• Last Updated: April 20, 2020
• Results First Posted: April 20, 2020

Record last verified: 2020-04

Locations

US (2)