Clinical Characteristics of Lymphatic Malformations

NCT06257719 | Completed DMC

• 1 other identifier: 2024-127
• Study Type: observational
• Target: 320
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lymphatic Malformation; Lymphangioma

Keywords

Lymphatic Malformation; Abdominal site; Preoperative complications; Resection; Mesentery; Acute abdomen

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (5)

• The incidence of abdominal lymphatic malformations in paediatric and adult group

  From 2009.1 to 2022.12

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

  From 2009.1 to 2022.12

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

  From 2009.1 to 2022.12

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

  From 2009.1 to 2022.12

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

  From 2009.1 to 2022.12

Study Arms (2)

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

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.

Adult group; Paediatric group

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• West China Hospital: lead

Study Sites (1)

West China Hospital of Sichuan University

Chengdu, Sichuan, 610041, China

Location

MeSH Terms

Conditions

Lymphatic Abnormalities; Lymphangioma; Abdomen, Acute

Interventions

Surgical Procedures, Operative; Risk Factors

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neoplasm, Lymphatic Tissue; Neoplasms by Histologic Type; Neoplasms; Abdominal Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive

Intervention Hierarchy (Ancestors)

Risk; Probability; Statistics as Topic; Epidemiologic Methods; Investigative Techniques; Causality; Epidemiologic Factors; Quality of Health Care; Health Care Quality, Access, and Evaluation; Health Care Evaluation Mechanisms; Public Health; Environment and Public Health

Study Officials

• Yi Ji, Ph.D.

  West China Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 16, 2024
• First Posted: February 14, 2024
• Study Start: January 1, 2009
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2023
• Last Updated: February 14, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)