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The Application of Probe-based Confocal Laser Endomicroscopy in the Diagnosis of Deep Endometriosis

Primary Purpose

Bowel Endometriosis

Status
Withdrawn
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
probe-based Confocal Laser Endomicroscopy
Cellvizio
fluorescein 10%
Sponsored by
Dr. Ofir Harnoy MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Bowel Endometriosis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Endometriosis

Exclusion Criteria:

  • Unable or unwilling to give and sign an informed consent
  • Allergy to fluorescein
  • Colitis
  • Critical illness
  • Pregnancy
  • Malignancy

Sites / Locations

  • Sheba Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Study group

Arm Description

a probe-based Confocal Laser Endomicroscopy examination will be done using a standard recto-sigmoidoscopy, in women suffering from endometriosis who are referred for a TRUS examination as part of a suspected deep endometriosis diagnostic workup. pCLE images will be compared to normal bowel mucosa.

Outcomes

Primary Outcome Measures

recognizing unique pCLE images for endometriosis

Secondary Outcome Measures

Full Information

First Posted
August 31, 2015
Last Updated
October 21, 2017
Sponsor
Dr. Ofir Harnoy MD
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1. Study Identification

Unique Protocol Identification Number
NCT02547909
Brief Title
The Application of Probe-based Confocal Laser Endomicroscopy in the Diagnosis of Deep Endometriosis
Official Title
The Application of Probe-based Confocal Laser Endomicroscopy in the Diagnosis of Deep Endometriosis
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Withdrawn
Study Start Date
May 2016 (undefined)
Primary Completion Date
October 2017 (Anticipated)
Study Completion Date
October 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dr. Ofir Harnoy MD

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Endometriosis is defined as the presence of endometrial glands and stroma outside of the uterus.Endometriosis affects 5%-15% of women in the reproductive age. Deep endometriosis is mostly defined as a single endometrial nodule, located in the vesico-uterine fold or close to the distal 20 cm of the large bowel. Current guidelines recommends that laparoscopy with histology should be done to diagnose endometriosis. Probe-based confocal laser endomicroscopy (pCLE) has been used as a GI tract endoscopy additive tool in recent years, providing in-vivo cellular-level imaging, a concept known as "optical biopsy". considering the rectal bleeding that occurs in patients suffering from bowel endometriosis, usually with a normal mucosa seen at standard endoscopy (personal data), we hypothesized that there might be histological architectural changes in the vessels or the mucosa/sub mucosa in bowel endometriosis.
Detailed Description
Endometriosis is defined as the presence of endometrial glands and stroma outside of the uterus, most commonly over the ovaries, fallopian tubes, bladder, recto-sigmoid colon and the uterine myometrium.Endometriosis affects 5%-15% of women in the reproductive age causing pelvic or abdominal pain, infertility and occasionally rectal bleeding (if involving the bowel). Deep endometriosis is mostly defined as a single endometrial nodule, usually larger than 1 cm which is located in the vesico-uterine fold or close to the distal 20 cm of the large bowel. Those lesions usually infiltrate at least 5 mm into the tissue involved. The gold standard of diagnosis is histological proven endometriosis, usually obtained during explorative laparoscopy. Other imaging tests that aid in the diagnosis are trans-vaginal or trans-rectal sonography (TRUS), MRI & CT. Current guidelines recommends that laparoscopy with histology should be done to diagnose endometriosis. Negative (normal) laparoscopy is highly accurate in excluding endometriosis, but a positive laparoscopy (i.e. with macroscopic findings) without biopsy has a limited value. In practice, many clinicians refrain from taking biopsies due-to the risk of bowel surgery, particularly on an un-prepared bowel. Probe-based confocal laser endomicroscopy (pCLE) has been used as a GI tract endoscopy additive tool in recent years, providing in-vivo cellular-level imaging, a concept known as "optical biopsy". considering the rectal bleeding that occurs in patients suffering from bowel endometriosis, usually with a normal mucosa seen at standard endoscopy (personal data), we hypothesized that there might be histological architectural changes in the vessels or the mucosa/sub mucosa in bowel endometriosis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bowel Endometriosis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study group
Arm Type
Experimental
Arm Description
a probe-based Confocal Laser Endomicroscopy examination will be done using a standard recto-sigmoidoscopy, in women suffering from endometriosis who are referred for a TRUS examination as part of a suspected deep endometriosis diagnostic workup. pCLE images will be compared to normal bowel mucosa.
Intervention Type
Procedure
Intervention Name(s)
probe-based Confocal Laser Endomicroscopy
Other Intervention Name(s)
Cellvizio
Intervention Description
Eligible women will be offered to undergo pCLE examination. Conscious sedation will be offered to all patients, who will choose to receive it or not. pCLE will be done using a standard gastroscope, reaching a distance of 25 cm from the anus, to the level of the rectosigmoid angle. At this point, 2.5 ml fluorescein 10% will be injected. The pCLE probe (GastroFlex-UHD probe, Mauna Kea tech, Paris, France) will be inserted through the endoscope working channel and images will be recorded from areas suspected of harboring an endometriotic tissue.
Intervention Type
Device
Intervention Name(s)
Cellvizio
Intervention Type
Drug
Intervention Name(s)
fluorescein 10%
Primary Outcome Measure Information:
Title
recognizing unique pCLE images for endometriosis
Time Frame
intraoperative

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Endometriosis Exclusion Criteria: Unable or unwilling to give and sign an informed consent Allergy to fluorescein Colitis Critical illness Pregnancy Malignancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ofir Har-Noy, MD
Organizational Affiliation
Sheba Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sheba Medical Center
City
Ramat Gan
ZIP/Postal Code
52621
Country
Israel

12. IPD Sharing Statement

Learn more about this trial

The Application of Probe-based Confocal Laser Endomicroscopy in the Diagnosis of Deep Endometriosis

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