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

Bowel Endometriosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02547909
• Other study ID #: 2146-15-SMC
• Status: Withdrawn
• Phase: N/A
• First received: August 31, 2015
• Last updated: October 21, 2017
• Start date: May 2016
• Est. completion date: October 2017

Study information

• Verified date: October 2017
• Source: Sheba Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Endometriosis

Exclusion Criteria:

• Unable or unwilling to give and sign an informed consent

• Allergy to fluorescein

• Colitis

• Critical illness

• Pregnancy

• Malignancy

Related Conditions & MeSH terms

• Bowel Endometriosis
• Endometriosis

Intervention

Procedure:
• probe-based Confocal Laser Endomicroscopy
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.

Device:
• Cellvizio

Drug:
• fluorescein 10%

Locations

Country	Name	City	State
Israel	Sheba Medical Center	Ramat Gan

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Ofir Harnoy MD

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	recognizing unique pCLE images for endometriosis		intraoperative