Clinical Characteristics of Lymphatic Malformations

Clinical Characteristics of Lymphatic Malformations: An Observational Study

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.

Study Overview

• Status: Completed
• Conditions: Lymphangioma; Lymphatic Malformation
• Intervention / Treatment: Other: Compare the epidemiological characteristics, clinical presentations, surgical treatments and risk factors for preoperative complications of ALMs between paediatric and adult participants.

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.

• Study Type: Observational
• Enrollment (Actual): 320

Contacts and Locations

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • West China Hospital of Sichuan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.; 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.; Compare the epidemiological characteristics, clinical presentations, surgical treatments and risk factors for preoperative complications of ALMs between paediatric and adult participants.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The location of abdominal lymphatic malformations in participants	Location included mesentery, retroperitoneum, omentum, spleen, etc.	From 2009.1 to 2022.12
The morphologic subtypes of abdominal lymphatic malformations in participants	Morphologic subtypes included macrocystic, microcystic and mixed type.	From 2009.1 to 2022.12
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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

Collaborators and Investigators

• Sponsor: West China Hospital
• Investigators: Principal Investigator: Yi Ji, Ph.D., West China Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2009
• Primary Completion (Actual): December 1, 2022
• Study Completion (Actual): December 1, 2023

Study Registration Dates

• First Submitted: January 16, 2024
• First Submitted That Met QC Criteria: February 5, 2024
• First Posted (Actual): February 14, 2024

Study Record Updates

• Last Update Posted (Actual): February 14, 2024
• Last Update Submitted That Met QC Criteria: February 5, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Resection; Lymphatic Malformation; Mesentery; Abdominal site; Preoperative complications; Acute abdomen
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Lymphatic Diseases; Lymphatic Vessel Tumors; Congenital Abnormalities; Lymphangioma; Lymphatic Abnormalities
• Other Study ID Numbers: 2024-127

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No