Phrenic Nerve InjuryNCT06775873
Modified Diaphragmatic Plication Rectifies Dyspnea
An observational study of Phrenic Nerve Injury, run by Tongji University at 1 site in China.
Trial summary
Traditional diaphragmatic plication (DP) surgery is employed to ameliorate respiratory function in patients with diaphragmatic paralysis, which is rather complicated. This study introduces a modified method of DP. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Phrenic Nerve Injury
- What is being tested?
- Modified diaphragmatic plication
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2023to 1 Jun 2024
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients who underwent mediastinal tumor resection and MDP between 2020 and 2024 at Shanghai General Hospital. All patients underwent plain chest X-ray or computed tomography (CT) scans prior to surgery to confirm diaphragmatic elevation. Each patient was followed for a minimum of six months.
Who may be able to join
- Preoperative chest X-ray suggesting diaphragmatic eventration, for which therapeutic MDP was performed;
- Mediastinal tumors encircling the phrenic nerve that could not be dissected or phrenic nerve injury occurring during intraoperative dissection, for which prophylactic MDP was performed;
- Diaphragmatic eventration and dyspnea following mediastinal surgery, for which salvage MDP was performed.
Who cannot join
- Congenital diaphragmatic deformity or diaphragmatic weakness due to poor general nutritional status;
- Morbid obesity with a BMI greater than 35 kg/m2;
- Neuromuscular diseases, including amyotrophic lateral sclerosis and myasthenia gravis;
- A history of upper abdominal surgery; and (5) Diaphragmatic calcification or fibrosis.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai General Hospital Shanghai Jiao Tong University School of Medicine
Shanghai, Hongkou Distri, 200080
About this study
Official title: Modified Diaphragmatic Plication Rectifies Dyspnea With Diaphragmatic Eventration Caused by Phrenicotomy or Injuries Involved in Extended Mediastinal Surgeries
Traditional diaphragmatic plication (DP) surgery is employed to ameliorate respiratory function in patients with diaphragmatic paralysis, which is rather complicated. This study introduces a modified method of DP. The efficacy of modified diaphragmatic plication (MDP) in preventing, treating, and relieving dyspnea in patients with phrenic nerve resection or injury due to extensive surgical intervention or local tumor invasion will be evaluated.
- Conditions
- Phrenic Nerve Injury
- Being tested
- Modified diaphragmatic plication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified diaphragmatic plicationProcedure or surgery
Modified diaphragm plication (MDP) using a cutting stapler consists of four steps: clamping and lifting, depressing and resecting, cutting and verifying, and hemostasis and reinforcement.
What is being measured
The primary outcome is the main question the study is designed to answer.
Effective rates of prevention of diaphragmatic elevation
Measured: 1 year
Success in correcting diaphragmatic elevation
Measured: 1 year
Secondary outcomes (1)
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2025
- Study start1 Feb 2023
- Primary completion1 May 2023
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Phrenic Nerve InjuryStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tongji University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiang Fan, Tongji University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06775873
- Sponsor's protocol ID
- MDP 010
- Other IDs
- 0347130
- Status last verified
- Jan 2025
- First submitted
- 31 Dec 2024
- Last updated
- 15 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Wright CD, Williams JG, Ogilvie CM, Donnelly RJ. Results of diaphragmatic plication for unilateral diaphragmatic paralysis. J Thorac Cardiovasc Surg. 1985 Aug;90(2):195-8.
PubMed 3927067
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modified Diaphragmatic Plication Rectifies Dyspnea With Diaphragmatic Eventration Caused by Phrenicotomy or Injuries Involved in Extended Mediastinal Surgeries
- ClinicalTrials.gov ID
- NCT06775873
- Acronym / sponsor ID
- MDP 010
- Conditions
- Phrenic Nerve Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Tongji UniversityUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 1 May 2023 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 15 Jan 2025 (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.
Traditional diaphragmatic plication (DP) surgery is employed to ameliorate respiratory function in patients with diaphragmatic paralysis, which is rather complicated. This study introduces a modified method of DP. The efficacy of modified diaphragmatic plication (MDP) in preventing, treating, and relieving dyspnea in patients with phrenic nerve resection or injury due to extensive surgical intervention or local tumor invasion will be evaluated.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients who underwent mediastinal tumor resection and MDP between 2020 and 2024 at Shanghai General Hospital. All patients underwent plain chest X-ray or computed tomography (CT) scans prior to surgery to confirm diaphragmatic elevation. Each patient was followed for a minimum of six months.
Key inclusion criteria (3 listed)
- Preoperative chest X-ray suggesting diaphragmatic eventration, for which therapeutic MDP was performed;
- Mediastinal tumors encircling the phrenic nerve that could not be dissected or phrenic nerve injury occurring during intraoperative dissection, for which prophylactic MDP was performed;
- Diaphragmatic eventration and dyspnea following mediastinal surgery, for which salvage MDP was performed.
Key exclusion criteria (4 listed)
- Congenital diaphragmatic deformity or diaphragmatic weakness due to poor general nutritional status;
- Morbid obesity with a BMI greater than 35 kg/m2;
- Neuromuscular diseases, including amyotrophic lateral sclerosis and myasthenia gravis;
- A history of upper abdominal surgery; and (5) Diaphragmatic calcification or fibrosis.
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 |
|---|---|---|
| Modified diaphragmatic plicationModified diaphragm plication (MDP) using a cutting stapler consists of four steps: clamping and lifting, depressing and resecting, cutting and verifying, and hemostasis and reinforcement. | Procedure or surgery | – |
Primary outcome
Effective rates of prevention of diaphragmatic elevation
Time frame: 1 year
Success in correcting diaphragmatic elevation
Time frame: 1 year
1 secondary outcome
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: 1 year
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 15 Jan 2025.
- Background: PubMed 3927067Wright CD, Williams JG, Ogilvie CM, Donnelly RJ. Results of diaphragmatic plication for unilateral diaphragmatic paralysis. J Thorac Cardiovasc Surg. 1985 Aug;90(2):195-8.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Phrenic Nerve Injury, run by Tongji University 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 3 inclusion and 4 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 15 Jan 2025. 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?
Effective rates of prevention of diaphragmatic elevation (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06775873, which also lists 1 linked publication.
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 15 Jan 2025; AzTrials last refreshed its copy on 27 Oct 2026.