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Completed

NCT Number: NCT06257719

Clinical Characteristics of Lymphatic Malformations

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.

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Key information

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Other

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

Primary outcomes

  1. The location of abdominal lymphatic malformations in participants

    Time frame: From 2009.1 to 2022.12

    Location included mesentery, retroperitoneum, omentum, spleen, etc.

  2. The morphologic subtypes of abdominal lymphatic malformations in participants

    Time frame: From 2009.1 to 2022.12

    Morphologic subtypes included macrocystic, microcystic and mixed type.

  3. The presentations at diagnosis of abdominal lymphatic malformations in participants

    Time frame: From 2009.1 to 2022.12

    Presentations at diagnosis included chronic pain, acute abdominal disease and incidental health checkup.

  4. The largest diameter of abdominal lymphatic malformations in participants

    Time frame: From 2009.1 to 2022.12

    Largest diameter in centimeters was mainly measured by intraoperative detections.

  5. The preoperative complications of abdominal lymphatic malformations in participants

    Time frame: From 2009.1 to 2022.12

    Preoperative complications included intestinal volvulus, haemorrhage, infection, rupture and compression.

Secondary outcomes

  1. The incidence of abdominal lymphatic malformations in paediatric and adult group

    Time frame: From 2009.1 to 2022.12

    Incidence of abdominal lymphatic malformations in paediatric and adult group was retrospectively compared.

  2. The number of female patients with abdominal lymphatic malformations in paediatric and adult group

    Time frame: From 2009.1 to 2022.12

    Number of female patients with abdominal lymphatic malformations in paediatric and adult group was retrospectively compared.

  3. The rate of abdominal lymphatic malformations with acute abdomen in paediatric and adult group

    Time frame: From 2009.1 to 2022.12

    Rate of abdominal lymphatic malformations with acute abdomen in paediatric and adult group was retrospectively compared.

  4. The rate of abdominal lymphatic malformations located in mesentery for paediatric and adult group

    Time frame: From 2009.1 to 2022.12

    Rate of abdominal lymphatic malformations located in mesentery for paediatric and adult group was retrospectively compared.

  5. The risk factors of preoperative complications of abdominal lymphatic malformations for paediatric and adult group.

    Time frame: From 2009.1 to 2022.12

    Risk factors of preoperative complications of abdominal lymphatic malformations for paediatric and adult group was retrospectively compared.

Sponsors and collaborators

Lead sponsor

West China Hospital

Other

Registry information

Official study title

Clinical Characteristics of Lymphatic Malformations: An Observational Study

Important dates

Study start
2009
Primary completion
2022
Study completion
2023
First posted
Feb 14, 2024
Registry last updated
Feb 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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