PancreatectomyNCT06424431
Methods of Pancreatic Stump Closure for Distal Pancreatectomy
A study testing stapler combined with electrocautery and simple closure with a closure device in people with Pancreatectomy, run by Changhai Hospital at 1 site in China.
Trial summary
The aim of this study is to conduct a retrospective analysis of patients who underwent distal pancreatectomy in our hospital, aiming to evaluate the safety and feasibility of two methods for closure of the pancreatic remnant: simple closure with a closure device and closure combined with electrocoagulation. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pancreatectomy
- What is being tested?
- stapler combined with electrocautery and simple closure with a closure device
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 487 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2019to 1 Apr 2024
- Phase
- Interventional
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who underwent distal pancreatectomy performed by Director Jin Gang's team at Changhai Hospital affiliated with Naval Medical University between January 2019 and January 2023.
- Patients who underwent closure of the pancreatic remnant using either simple closure or closure combined with electrocoagulation during surgery.
Who cannot join
- Patients undergoing surgeries by other primary clinical teams during the same period.
- Patients undergoing closure of the pancreatic remnant using methods other than those mentioned.
- Patients who violate the requirements of the study protocol.
- Patients with incomplete data collection in the hospital's diagnostic and treatment system.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Stapler Versus Stapler Combined With Electrocautery for Pancreatic Transection and Stump Closure for Distal Pancreatectomy
The aim of this study is to conduct a retrospective analysis of patients who underwent distal pancreatectomy in our hospital, aiming to evaluate the safety and feasibility of two methods for closure of the pancreatic remnant: simple closure with a closure device and closure combined with electrocoagulation.
Read the detailed description
The aim of this study is to conduct a retrospective analysis of patients who underwent distal pancreatectomy in our hospital, aiming to evaluate the safety and feasibility of two methods for closure of the pancreatic remnant: simple closure with a closure device and closure combined with electrocoagulation. This study aims to determine which method is safer and more feasible, with the potential to reduce postoperative complications, improve outcomes, facilitate better patient recovery, and thereby provide better guidance for clinical practice.
- Conditions
- Pancreatectomy
- Being tested
- stapler combined with electrocautery, simple closure with a closure device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stapler combined with electrocauteryProcedure or surgery
Closure with a closure device combined with electrocoagulation for pancreatic stump closure in distal pancreatectomy
simple closure with a closure deviceProcedure or surgery
Simple closure with a closure device for pancreatic stump closure in distal pancreatectomy
| Study group | Role | What they receive |
|---|---|---|
| Stapler | Other | Simple closure with a closure device for closure of the pancreatic remnant in distal pancreatectomy. Receives: Procedure: simple closure with a closure device |
| Stapler combined with electrocautery | Experimental | Closure with a closure device combined with electrocoagulation for closure of the pancreatic remnant in distal pancreatectomy. Receives: Procedure: stapler combined with electrocautery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pancreatic fistula
Postoperative pancreatic fistula
Measured: perioperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2024
- Study start1 Jan 2019
- Primary completion31 Jan 2023
- Study completion1 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PancreatectomyStudies of the same condition, open and under way.
- More trials run by Changhai 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 487 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06424431
- Sponsor's protocol ID
- CHEC2024-110
- Status last verified
- May 2024
- First submitted
- 3 Apr 2024
- Last updated
- 22 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stapler Versus Stapler Combined With Electrocautery for Pancreatic Transection and Stump Closure for Distal Pancreatectomy
- ClinicalTrials.gov ID
- NCT06424431
- Acronym / sponsor ID
- CHEC2024-110
- Conditions
- Pancreatectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 487 participants (actual)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Jan 2023 (actual)
- Study completion
- 1 Apr 2024 (actual)
- First posted
- 22 May 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 aim of this study is to conduct a retrospective analysis of patients who underwent distal pancreatectomy in our hospital, aiming to evaluate the safety and feasibility of two methods for closure of the pancreatic remnant: simple closure with a closure device and closure combined with electrocoagulation.
Detailed description
The aim of this study is to conduct a retrospective analysis of patients who underwent distal pancreatectomy in our hospital, aiming to evaluate the safety and feasibility of two methods for closure of the pancreatic remnant: simple closure with a closure device and closure combined with electrocoagulation. This study aims to determine which method is safer and more feasible, with the potential to reduce postoperative complications, improve outcomes, facilitate better patient recovery, and thereby provide better guidance for clinical practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stapler | Other | Procedure: simple closure with a closure deviceSimple closure with a closure device for closure of the pancreatic remnant in distal pancreatectomy. |
| Stapler combined with electrocautery | Experimental | Procedure: stapler combined with electrocauteryClosure with a closure device combined with electrocoagulation for closure of the pancreatic remnant in distal pancreatectomy. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients who underwent distal pancreatectomy performed by Director Jin Gang's team at Changhai Hospital affiliated with Naval Medical University between January 2019 and January 2023.
- Patients who underwent closure of the pancreatic remnant using either simple closure or closure combined with electrocoagulation during surgery.
Key exclusion criteria (4 listed)
- Patients undergoing surgeries by other primary clinical teams during the same period.
- Patients undergoing closure of the pancreatic remnant using methods other than those mentioned.
- Patients who violate the requirements of the study protocol.
- Patients with incomplete data collection in the hospital's diagnostic and treatment system.
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 |
|---|---|---|
| stapler combined with electrocauteryClosure with a closure device combined with electrocoagulation for pancreatic stump closure in distal pancreatectomy | Procedure or surgery | Stapler combined with electrocautery |
| simple closure with a closure deviceSimple closure with a closure device for pancreatic stump closure in distal pancreatectomy | Procedure or surgery | Stapler |
Primary outcome
Postoperative pancreatic fistula
Time frame: perioperatively
Postoperative pancreatic fistula
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 22 May 2024.
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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?
A study testing stapler combined with electrocautery and simple closure with a closure device in people with Pancreatectomy, run by Changhai 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 2 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 22 May 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?
Postoperative pancreatic fistula (time frame: perioperatively). 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 22 May 2024.