Efficacy of Double Contrast-enhanced Ultrasound of Pelvic in Preoperative Evaluation of Deep Endometriosis

Deep Endometriosis Clinical Trial

Official title:

Efficacy of Double Contrast-enhanced Ultrasound of Pelvic in Preoperative Evaluation of Deep Endometriosis: a Prospective Diagnostic Test

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05540821
• Other study ID #: 20223357017
• Status: Recruiting
• Start date: June 1, 2022
• Est. completion date: June 30, 2025

Study information

• Verified date: September 2022
• Source: Shenzhen Second People's Hospital
• Contact: Qiuxiang Chen
• Phone: 0755-83366388-8856
• Email: 616441594[@]qq.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Endometriosis occurs in about 10-15% of women of childbearing age and is a major cause of infertility and dysmenorrhea. Deep endometriosis is the most serious manifestation of endometriosis, which often affects the quality of life of patients and requires surgical treatment. Detailed description of DE lesions before operation can contribute to treatment planning. However, the detection rate of DE by conventional ultrasound is low, highly dependent on the experience of the examiner and poor reproducibility. Hysterosalpingo-contrast sonography can be used to assess the patency of the fallopian tube but cannot visualize other pelvic structures. Saline-infusion sonoPODography can provide a good acoustic window for pelvic tissue visualization. Therefore, this study is the first to present double contrast-enhanced ultrasound (Hysterosalpingo-contrast sonography and sonoPODography) examination of the pelvic cavity, based on the #Enzian classification system, for preoperative evaluation of DE lesions. The results of laparoscopic surgery were taken as the gold standard to compare the diagnostic efficacy of double contrast-enhanced ultrasound and conventional transvaginal ultrasound in preoperative evaluation of pelvic DE lesions, improving the preoperative diagnosis, reduce the risk of surgery and reduce postoperative recurrence. To compare the diagnostic efficacy of different examination methods in different compartment of DE, and to explore the best examination method suitable for different parts of DE, providing theoretical basis for further early screening and personalized treatment of DE in the future.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 156
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

1. Female patients diagnosed with adenomyosis and/or chocolate cysts, suspected infertility with endometriosis, and proposed for laparoscopic surgery at our hospital.

2. Sexual life history.

3. Surgery was performed within 2 months of the examination.

4. Subjects volunteered to participate in the study and signed the informed consent form.

Exclusion Criteria:

1. colporrhagia.

2. Acute inflammation of reproductive system.

3. Allergic to ultrasound contrast agent (Sonovue).

4. Suspected malignant lesions of cervix or uterine cavity.

Related Conditions & MeSH terms

• Deep Endometriosis
• Endometriosis

Intervention

Diagnostic Test:
• Hysterosalpingo-contrast sonography and sonoPODography
Before operation, phloroglucinol 40mg of antispasmolysis was injected intramuscular, and then cervical dilation was performed according to aseptic operation requirements. A 12G double-lumen catheter was inserted into the uterine cavity, and 1.5-1.8ml of normal saline was injected into the sacculus. Transvaginal 2/3/4D hysterosalpingo-contrast sonography: One operator extracted 2ml of Sonovue and injected 18ml of normal saline through a dual-lumen catheter, and the other operator started the four-dimensional ultrasound mode to collect dynamic volume data. sonoPODography: Sterile saline was injected into the intrauterine cavity, with an upper limit of 20ml. The normal saline flowed from the intrauterine cavity into the pelvic cavity through the bilateral fallopian tubes, forming a good acoustic window. Pelvic observation was then performed.

Locations

Country	Name	City	State
China	Shenzhen Second People's Hospital	Shenzhen	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Shenzhen Second People's Hospital

Country where clinical trial is conducted

China, 

References & Publications (5)

Exacoustos C, Malzoni M, Di Giovanni A, Lazzeri L, Tosti C, Petraglia F, Zupi E. Ultrasound mapping system for the surgical management of deep infiltrating endometriosis. Fertil Steril. 2014 Jul;102(1):143-150.e2. doi: 10.1016/j.fertnstert.2014.03.043. Epub 2014 Apr 29. — View Citation

Leonardi M, Espada M, Lu C, Stamatopoulos N, Condous G. A Novel Ultrasound Technique Called Saline Infusion SonoPODography to Visualize and Understand the Pouch of Douglas and Posterior Compartment Contents: A Feasibility Study. J Ultrasound Med. 2019 Dec;38(12):3301-3309. doi: 10.1002/jum.15022. Epub 2019 May 15. — View Citation

Nisenblat V, Bossuyt PM, Farquhar C, Johnson N, Hull ML. Imaging modalities for the non-invasive diagnosis of endometriosis. Cochrane Database Syst Rev. 2016 Feb 26;2:CD009591. doi: 10.1002/14651858.CD009591.pub2. Review. — View Citation

Taylor HS, Kotlyar AM, Flores VA. Endometriosis is a chronic systemic disease: clinical challenges and novel innovations. Lancet. 2021 Feb 27;397(10276):839-852. doi: 10.1016/S0140-6736(21)00389-5. Review. — View Citation

Tuttlies F, Keckstein J, Ulrich U, Possover M, Schweppe KW, Wustlich M, Buchweitz O, Greb R, Kandolf O, Mangold R, Masetti W, Neis K, Rauter G, Reeka N, Richter O, Schindler AE, Sillem M, Terruhn V, Tinneberg HR. [ENZIAN-score, a classification of deep infiltrating endometriosis]. Zentralbl Gynakol. 2005 Oct;127(5):275-81. Review. German. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	True positive rate	According to the #Enzian classification system, the proportion of the number of DE lesions found by double contrast-enhanced ultrasound (DCEUS) in the pelvic cavity to the number of DE lesions found by laparoscopy.	Surgery was performed within 2 months of the examination
Primary	True negative rate	According to the #Enzian classification system, the proportion of pelvic normal numbers shown by DCEUS to the number of pelvic normal numbers show by laparoscopy.	Surgery was performed within 2 months of the examination
Primary	False negative rate	According to the #Enzian classification system, the proportion of pelvic DE lesions that were not detected by DCEUS in pelvic DE lesions.	Surgery was performed within 2 months of the examination
Primary	False positive rate	According to the #Enzian classification system, in the non-pelvic DE lesions, the proportion of the number of DE lesions diagnosed by pelvic dual contrast-enhanced ultrasound accounted for.	Surgery was performed within 2 months of the examination