Lymphatic MalformationNCT06257719
Clinical Characteristics of Lymphatic Malformations
An observational study of Lymphatic Malformation and Lymphangioma, run by West China Hospital at 1 site in China.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lymphatic Malformation, Lymphangioma
- What is being tested?
- Compare the epidemiological characteristics, clinical presentations, surgical treatments and risk factors for preoperative complications of ALMs between paediatric and adult participants.
- How many people
- 320 participants
- Where
- 1 siteChina
- Study dates
- Jan 2009to Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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.
- Conditions
- Lymphatic Malformation, Lymphangioma
- Being tested
- Compare the epidemiological characteristics, clinical presentations, surgical treatments and risk factors for preoperative complications of ALMs between paediatric and adult participants.
- Keywords
- Lymphatic Malformation, Abdominal site, Preoperative complications, Resection, Mesentery, Acute abdomen
- Medical subject headings
- Lymphatic Abnormalities, Lymphangioma, Abdomen, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Paediatric group | The investigators defined participants under 14 years old as the paediatric group. Receives: 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. Receives: Other: Compare the epidemiological characteristics, clinical presentations, surgical treatments and risk factors for preoperative complications of ALMs between paediatric and adult participants. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The location of abdominal lymphatic malformations in participants
Location included mesentery, retroperitoneum, omentum, spleen, etc.
Measured: From 2009.1 to 2022.12
The morphologic subtypes of abdominal lymphatic malformations in participants
Morphologic subtypes included macrocystic, microcystic and mixed type.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From 2009.1 to 2022.12
Secondary outcomes (5)
The incidence of abdominal lymphatic malformations in paediatric and adult group
Incidence of abdominal lymphatic malformations in paediatric and adult group was retrospectively compared.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From 2009.1 to 2022.12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2024
- Study startJan 2009
- Primary completionDec 2022
- Study completionDec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphatic MalformationStudies of the same condition, open and under way.
- More trials run by West China HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 320 participants (actual)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yi Ji, West China Hospital
- Investigators
- Yi Ji, Ph.D., Principal investigator, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06257719
- Sponsor's protocol ID
- 2024-127
- Status last verified
- Feb 2024
- First submitted
- 16 Jan 2024
- Last updated
- 14 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Characteristics of Lymphatic Malformations: An Observational Study
- ClinicalTrials.gov ID
- NCT06257719
- Acronym / sponsor ID
- 2024-127
- Conditions
- Lymphatic Malformation, Lymphangioma
- Keywords
- Lymphatic Malformation, Abdominal site, Preoperative complications, Resection, Mesentery, Acute abdomen
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 320 participants (actual)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- Jan 2009 (actual)
- Primary completion
- Dec 2022 (actual)
- Study completion
- Dec 2023 (actual)
- First posted
- 14 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Paediatric group | – | Other: Compare the epidemiological characteristics, clinical presentations, surgical treatments and risk factors for preoperative complications of ALMs between paediatric and adult participants.The investigators defined participants under 14 years old as the paediatric group. |
| Adult group | – | Other: Compare the epidemiological characteristics, clinical presentations, surgical treatments and risk factors for preoperative complications of ALMs between paediatric and adult participants.The investigators defined participants over 14 years old as the adult group. |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Adult group, Paediatric group |
Primary outcome
The location of abdominal lymphatic malformations in participants
Time frame: From 2009.1 to 2022.12
Location included mesentery, retroperitoneum, omentum, spleen, etc.
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.
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.
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.
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.
5 secondary outcomes
The incidence of abdominal lymphatic malformations in paediatric and adult group
Time frame: From 2009.1 to 2022.12
The number of female patients with abdominal lymphatic malformations in paediatric and adult group
Time frame: From 2009.1 to 2022.12
The rate of abdominal lymphatic malformations with acute abdomen in paediatric and adult group
Time frame: From 2009.1 to 2022.12
The rate of abdominal lymphatic malformations located in mesentery for paediatric and adult group
Time frame: From 2009.1 to 2022.12
The risk factors of preoperative complications of abdominal lymphatic malformations for paediatric and adult group.
Time frame: From 2009.1 to 2022.12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yi Ji, Ph.D. principal investigator
West China Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lymphatic Malformation and Lymphangioma, run by West China Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The location of abdominal lymphatic malformations in participants (time frame: From 2009.1 to 2022.12). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2024.