Clinical trial NCT05540821: Efficacy of Double Contrast-enhanced Ultrasound of Pelvic in Preoperative Evaluation of Deep Endometriosis
Official title: Efficacy of Double Contrast-enhanced Ultrasound of Pelvic in Preoperative Evaluation of Deep Endometriosis: a Prospective Diagnostic Test
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Deep Endometriosis
Keywords: Deep endometriosis
contrast-enhanced ultrasound
#Enzian classification
preoperative evaluation
Lead sponsor: Shenzhen Second People's Hospital
Sponsor class: OTHER
First posted: 2022-09-15
Enrollment: 156
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive female patients admitted to Shenzhen Second People's Hospital planned to undergo laparoscopic surgery from June 2022 to October 2024 with adenomyosis and/or chocolate cyst, suspected infertility complicated with endometriosis were included.

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: True positive rate
timeFrame: Surgery was performed within 2 months of the examination
measure: True negative rate
timeFrame: Surgery was performed within 2 months of the examination
measure: False negative rate
timeFrame: Surgery was performed within 2 months of the examination
measure: False positive rate
timeFrame: Surgery was performed within 2 months of the examination
Secondary outcomes:
Other outcomes:
Locations:
city: Shenzhen
country: China
facility: Shenzhen Second People's Hospital
state: Guangdong
Study officials:
affiliation: Shenzhen Second People's Hospital
name: Jian Chen
role: STUDY_DIRECTOR
References:
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.
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(2):CD009591. doi: 10.1002/14651858.CD009591.pub2.
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. doi: 10.1055/s-2005-836904. German.
citation: 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.
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.