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CompletedNCT06257719Updated Feb 14, 2024

Clinical Characteristics of Lymphatic Malformations

An observational study in Lymphatic Malformation and Lymphangioma, sponsored by West China Hospital. Completed at 1 site in China. Per ClinicalTrials.gov, last updated 2024-02-14.

Sponsored by West China Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
320
Sex
All
01

Study 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.

Read the detailed 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.

02

Conditions studied

  • Lymphatic Malformation
  • Lymphangioma

Keywords

  • Lymphatic Malformation
  • Abdominal site
  • Preoperative complications
  • Resection
  • Mesentery
  • Acute abdomen
03

In context

Lymphatic Abnormalities

42 studies on the registry are indexed under Lymphatic Abnormalities; 17 are open to participants now.

This study's enrollment of 320 is above the median of 56 across 13 observational studies indexed under Lymphatic Abnormalities.

Browse Lymphatic Abnormalities studies →

Lead sponsor

West China Hospital is the lead sponsor of 501 studies on the registry; 246 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Sampling method
Non-probability sample

Study population

In this study, The investigators retrospectively collected and compared the data related to the preoperative information, intraoperative findings and postoperative pathological analysis of the enrolled abdominal lymphatic malformations for paediatric and adult participants.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • The investigators enrolled participants who were 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

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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
320 participants (actual)
Patient registry
No

Groups and cohorts

  • Paediatric group

    The investigators defined participants under 14 years old as the paediatric group.

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

  • Adult group

    The investigators defined participants over 14 years old as the adult group.

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

Interventions

  • OtherCompare 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.

06

What researchers measure

Primary outcomes

  1. The location of abdominal lymphatic malformations in participants

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

    Time frame: From 2009.1 to 2022.12

  2. The morphologic subtypes of abdominal lymphatic malformations in participants

    Morphologic subtypes included macrocystic, microcystic and mixed type.

    Time frame: From 2009.1 to 2022.12

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

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

    Time frame: From 2009.1 to 2022.12

  4. The largest diameter of abdominal lymphatic malformations in participants

    Largest diameter in centimeters was mainly measured by intraoperative detections.

    Time frame: From 2009.1 to 2022.12

  5. The preoperative complications of abdominal lymphatic malformations in participants

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

    Time frame: From 2009.1 to 2022.12

Secondary outcomes

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

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

    Time frame: From 2009.1 to 2022.12

  2. 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.

    Time frame: From 2009.1 to 2022.12

  3. 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.

    Time frame: From 2009.1 to 2022.12

  4. 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.

    Time frame: From 2009.1 to 2022.12

  5. 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.

    Time frame: From 2009.1 to 2022.12

07

Study locations

1 site
  • West China Hospital of Sichuan University
    Chengdu, Sichuan 610041, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 14, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06257719
Responsible party
Yi Ji (Principal Investigator, West China Hospital) — Principal investigator
First posted
Feb 14, 2024
Start date
Jan 2009
Primary completion
Dec 2022
Completion
Dec 2023
Last update
Feb 14, 2024

Study contacts

Yi Ji, Ph.D.
principal investigator · West China Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.

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