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

NCT02547909 | Withdrawn DMC

• 1 other identifier: 2146-15-SMC
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Bowel Endometriosis

Outcome Measures

Primary Outcomes (1)

• recognizing unique pCLE images for endometriosis

  intraoperative

Study Arms (1)

Study group

EXPERIMENTAL

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.

Procedure: probe-based Confocal Laser Endomicroscopy; Device: Cellvizio; Drug: fluorescein 10%

Interventions

probe-based Confocal Laser Endomicroscopy PROCEDURE

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.

Also known as: Cellvizio

Study group

Cellvizio DEVICE

Study group

fluorescein 10% DRUG

Study group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Endometriosis

You may not qualify if:

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

Sponsors & Collaborators

• Dr. Ofir Harnoy MD: lead

Study Sites (1)

Sheba Medical Center

Ramat Gan, 52621, Israel

Location

Study Officials

• Ofir Har-Noy, MD

  Sheba Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Staff physician

Study Record Dates

• First Submitted: August 31, 2015
• First Posted: September 11, 2015
• Study Start: May 1, 2016
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2017
• Last Updated: October 24, 2017

Record last verified: 2017-10

Locations

IL (1)