Clinical Characteristics of Lymphatic Malformations

Lymphatic Malformation Clinical Trial

Official title:

Clinical Characteristics of Lymphatic Malformations: An Observational Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06257719
• Other study ID #: 2024-127
• Status: Completed
• Start date: January 2009
• Est. completion date: December 2023

Study information

• Verified date: February 2024
• Source: West China Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The primary purpose of this study is to retrospectively identify the clinical characteristics of abdominal lymphatic malformations (ALMs) in our single center in China. The second objective of this study is to retrospectively compare the epidemiological features, clinical presentations, cyst properties, surgical treatments, and risk factors for preoperative complications of ALMs between paediatric participants and adult participants.

Description:

Lymphatic malformations (LMs) are vascular anomalies that arise from abnormal embryonic development of the lymphatic system and can present as dilated lymphatic channels or cysts lined by lymphatic endothelial cells. Abdominal lymphatic malformations (ALMs) are rare entities that account for fewer than 10% of LMs and may occur not only in the tissues or organs in the abdominal cavity, such as the mesentery, spleen and pancreas but also in the retroperitoneal space. ALMs can manifest as an infection, chronic abdominal discomfort, acute abdomen, or fatal disease.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 320
• Est. completion date: December 2023
• Est. primary completion date: December 2022
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• The investigators enrolled participants who were pathologically diagnosed with lymphangioma or lymphatic malformations in the abdominal cavity (i.e., abdominal lymphatic malformations) from January 2009 to December 2022 at our institution.

Exclusion Criteria:

• The investigators excluded participants without a pathological diagnosis of abdominal lymphatic malformations through resection specimens and those with pathological confirmation of other diseases, as well as patients with complex lymphatic anomalies.

Related Conditions & MeSH terms

• Congenital Abnormalities
• Lymphangioma
• Lymphatic Abnormalities
• Lymphatic Malformation

Intervention

Other:
• Compare the epidemiological characteristics, clinical presentations, surgical treatments and risk factors for preoperative complications of ALMs between paediatric and adult participants.
Compare the epidemiological characteristics, clinical presentations, surgical treatments and risk factors for preoperative complications of ALMs between paediatric and adult participants.

Locations

Country	Name	City	State
China	West China Hospital of Sichuan University	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
West China Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The location of abdominal lymphatic malformations in participants	Location included mesentery, retroperitoneum, omentum, spleen, etc.	From 2009.1 to 2022.12
Primary	The morphologic subtypes of abdominal lymphatic malformations in participants	Morphologic subtypes included macrocystic, microcystic and mixed type.	From 2009.1 to 2022.12
Primary	The presentations at diagnosis of abdominal lymphatic malformations in participants	Presentations at diagnosis included chronic pain, acute abdominal disease and incidental health checkup.	From 2009.1 to 2022.12
Primary	The largest diameter of abdominal lymphatic malformations in participants	Largest diameter in centimeters was mainly measured by intraoperative detections.	From 2009.1 to 2022.12
Primary	The preoperative complications of abdominal lymphatic malformations in participants	Preoperative complications included intestinal volvulus, haemorrhage, infection, rupture and compression.	From 2009.1 to 2022.12
Secondary	The incidence of abdominal lymphatic malformations in paediatric and adult group	Incidence of abdominal lymphatic malformations in paediatric and adult group was retrospectively compared.	From 2009.1 to 2022.12
Secondary	The number of female patients with abdominal lymphatic malformations in paediatric and adult group	Number of female patients with abdominal lymphatic malformations in paediatric and adult group was retrospectively compared.	From 2009.1 to 2022.12
Secondary	The rate of abdominal lymphatic malformations with acute abdomen in paediatric and adult group	Rate of abdominal lymphatic malformations with acute abdomen in paediatric and adult group was retrospectively compared.	From 2009.1 to 2022.12
Secondary	The rate of abdominal lymphatic malformations located in mesentery for paediatric and adult group	Rate of abdominal lymphatic malformations located in mesentery for paediatric and adult group was retrospectively compared.	From 2009.1 to 2022.12
Secondary	The risk factors of preoperative complications of abdominal lymphatic malformations for paediatric and adult group.	Risk factors of preoperative complications of abdominal lymphatic malformations for paediatric and adult group was retrospectively compared.	From 2009.1 to 2022.12