Distal PancreatectomyNCT05789459
Comparison of Outcomes With Stapler Versus Hand-Sewn Closure After Minimally Invasive Distal Pancreatectomy
An observational study of Distal Pancreatectomy and Postoperative Pancreatic Fistula, run by Zhejiang University at 1 site in China.
Trial summary
The incidence of postoperative pancreatic fistula (POPF) after Distal pancreatectomy (DP) remains high. Of the available mitigation strategies, high-quality closure of the pancreatic stump is fundamental. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Distal Pancreatectomy, Postoperative Pancreatic Fistula
- What is being tested?
- Stapler and Suture
- Type of treatment
- Medical device
- How many people
- 384 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2018to 30 Jun 2021
- 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
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who underwent MDP in our institution between July 2018 and June 2021.
Who may be able to join
- Underwent elective minimally invasive pancreatic body and tail resection with or without splenectomy
Who cannot join
- Incomplete medical records
- History of previous pancreatic operations
- Emergent operation
- Conversion to open pancreatectomy
- Receipt of wedge resection or other procedures
Trial locations and contacts
1 site in 1 country.
China1 site
the First Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310003
About this study
Official title: Comparison of Outcomes With Stapler Versus Hand-Sewn Closure of the Pancreatic Stump Following Minimally Invasive Distal Pancreatectomy: A Retrospective Cohort Study
The incidence of postoperative pancreatic fistula (POPF) after Distal pancreatectomy (DP) remains high. Of the available mitigation strategies, high-quality closure of the pancreatic stump is fundamental.
Researchers failed to find a decrease in the incidence of POPF after stapler closure of the pancreatic stump compared with that related to hand-sewn suture in DP. Minimally invasive DP (MDP) is becoming the first choice for patients and surgeons, few studies have evaluated whether stapler closure is superior to hand-sewn suture for stump closure in MDP.
Therefore, this retrospective study was aimed at evaluating the effect of stapler versus hand-sewn closure on the incidence of POPF after MDP.
- Being tested
- Stapler, Suture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StaplerDevice
Stapler
SutureOther
Suture
| Study group | Role | What they receive |
|---|---|---|
| Stapler group | closure with a stapler Receives: Device: Stapler | |
| Hand-sewn group | closure with suture Receives: Other: Suture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pancreatic fistula (POPF)
The outcome was POPF per the International Study Group of Pancreatic Surgery definition
Measured: Within 3 months after pancreatic surgery
Secondary outcomes (4)
delayed gastric emptying (DGE)
identified and graded according to the ISGPS criteria
Measured: Within 3 months after pancreatic surgery
postpancreatectomy hemorrhage (PPH)
identified and graded according to the ISGPS criteria
Measured: Within 3 months after pancreatic surgery
Chyle leak
identified and graded according to the ISGPS criteria
Measured: Within 3 months after pancreatic surgery
Surgical complications
classified according to the Clavien-Dindo system
Measured: Within 3 months after pancreatic surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2023
- Study start1 Jul 2018
- Primary completion30 Jun 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Distal PancreatectomyStudies of the same condition, open and under way.
- More trials run by Zhejiang UniversityThe 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
- 384 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, TingBo Liang, Zhejiang University
- Investigators
- Tingbo Liang, Principal investigator, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05789459
- Sponsor's protocol ID
- DP-POPF
- Status last verified
- Mar 2023
- First submitted
- 16 Mar 2023
- Last updated
- 29 Mar 2023
- 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 29 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Outcomes With Stapler Versus Hand-Sewn Closure of the Pancreatic Stump Following Minimally Invasive Distal Pancreatectomy: A Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT05789459
- Acronym / sponsor ID
- DP-POPF
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 384 participants (actual)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 29 Mar 2023 (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 incidence of postoperative pancreatic fistula (POPF) after Distal pancreatectomy (DP) remains high. Of the available mitigation strategies, high-quality closure of the pancreatic stump is fundamental.
Researchers failed to find a decrease in the incidence of POPF after stapler closure of the pancreatic stump compared with that related to hand-sewn suture in DP. Minimally invasive DP (MDP) is becoming the first choice for patients and surgeons, few studies have evaluated whether stapler closure is superior to hand-sewn suture for stump closure in MDP.
Therefore, this retrospective study was aimed at evaluating the effect of stapler versus hand-sewn closure on the incidence of POPF after MDP.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stapler group | – | Device: Staplerclosure with a stapler |
| Hand-sewn group | – | Other: Sutureclosure with suture |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who underwent MDP in our institution between July 2018 and June 2021.
Key inclusion criteria (1 listed)
- Underwent elective minimally invasive pancreatic body and tail resection with or without splenectomy
Key exclusion criteria (5 listed)
- Incomplete medical records
- History of previous pancreatic operations
- Emergent operation
- Conversion to open pancreatectomy
- Receipt of wedge resection or other procedures
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 |
|---|---|---|
| StaplerStapler | Device | Stapler group |
| SutureSuture | Other | Hand-sewn group |
Primary outcome
Postoperative pancreatic fistula (POPF)
Time frame: Within 3 months after pancreatic surgery
The outcome was POPF per the International Study Group of Pancreatic Surgery definition
4 secondary outcomes
delayed gastric emptying (DGE)
Time frame: Within 3 months after pancreatic surgery
postpancreatectomy hemorrhage (PPH)
Time frame: Within 3 months after pancreatic surgery
Chyle leak
Time frame: Within 3 months after pancreatic surgery
Surgical complications
Time frame: Within 3 months after pancreatic surgery
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 29 Mar 2023.
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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.
Tingbo Liang principal investigator
Zhejiang University
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 Distal Pancreatectomy and Postoperative Pancreatic Fistula, run by Zhejiang 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 1 inclusion and 5 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 29 Mar 2023. 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 (POPF) (time frame: Within 3 months after pancreatic surgery). 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 29 Mar 2023.