Safety IssuesNCT04892615
he Safety Research of Timing of the Removal of Abdominal Drains After Pancreatic Surgery
An observational study of Safety Issues, run by Xian-Jun Yu at 1 site in China.
Trial summary
Randomized, open, single-center, controlled prospective studies were designed to obtain reliable level I evidence in evidence-based medicine.Based on the premise of at least a 6-fold reduction in pancreatic fistula, as observed by Kawai et al after early drainage.Considering the overall incidence of pancreatic fistula… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Safety Issues
- What is being tested?
- drainage tube was removed on 5th days after surgery. and drainage tube was removed on 7th days after surgery.
- Type of treatment
- Medical device
- How many people
- 114 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2021to 30 Sep 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Prepare for elective pancreatic surgery, including laparoscopic or open pancreaticoduodenectomy and distal pancreaticocaudal body resection;
Who may be able to join
- ECOG 0-2;
- The amylase value in the drainage tube of patients receiving pancreaticoduodenectomy or distal pancreatectomy was lower than 5000 IU/L on the first day after surgery;
- postoperative drainage tube placement;
- Patients with no obvious contraindication to surgery;
- Expected postoperative survival ≥3 months;
Who cannot join
- Pancreaticoduodenectomy and pancreaticogastric anastomosis were performed;
- Suspicion or abdominal bleeding within 5 days after surgery;
- suspected biliary and intestinal fistula within 5 days after operation;
- On the fifth day after the operation, abdominal CT reexamination showed local effusion with a depth greater than 3cm.
Trial locations and contacts
1 site in 1 country.
China1 site
Xianjun Fudan Yu
Shanghai, Sahnghai
Xianjun F Yu, 18019112906, yuxianjun@fudanpci.org
About this study
Official title: The Safety Research of Timing of the Removal of Abdominal Drains After Pancreatic Surgery ： Results of a Prospective Randomized Clinical Trial
Randomized, open, single-center, controlled prospective studies were designed to obtain reliable level I evidence in evidence-based medicine.Based on the premise of at least a 6-fold reduction in pancreatic fistula, as observed by Kawai et al after early drainage.Considering the overall incidence of pancreatic fistula after standard pancreatectomy at our center (approximately 20%), we would expect this complication to occur in approximately 3.4% of cases in Group A.α was set as 0.05 and β was set as 0.2 (efficacy was 80%), indicating that the total number of study subjects was at least 114 patients (at least 57 patients in the experimental group and 57 patients in the control group).
- Conditions
- Safety Issues
- Being tested
- drainage tube was removed on 5th days after surgery., drainage tube was removed on 7th days after surgery.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
drainage tube was removed on 5th days after surgery.Device
drainage tube was removed on 5th days after surgery.
drainage tube was removed on 7th days after surgery.Device
drainage tube was removed on 7th days after surgery.
| Study group | Role | What they receive |
|---|---|---|
| Cohort A | The drainage tube was removed on the 5th day after surgery. Receives: Device: drainage tube was removed on 5th days after surgery. | |
| Cohort B | The drainage tube was removed on the 7th day after surgery. Receives: Device: drainage tube was removed on 7th days after surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of postoperative pancreatic fistula and abdominal infection;
Measured: 3month
Severity of complications (duration of postoperative hospital stay) was assessed by Dindo Clavien classification.
Measured: 3month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2021
- Study start1 Jun 2021 (estimated)
- Primary completion30 Jan 2024 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Safety IssuesStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 114 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xian-Jun Yu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xian-Jun Yu, Fudan University
- Investigators
- Xianjun F Yu, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04892615
- Sponsor's protocol ID
- CSPAC-34
- Status last verified
- May 2021
- First submitted
- 15 May 2021
- Last updated
- 19 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety Research of Timing of the Removal of Abdominal Drains After Pancreatic Surgery ： Results of a Prospective Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04892615
- Acronym / sponsor ID
- CSPAC-34
- Conditions
- Safety Issues
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- Xian-Jun YuUniversity, hospital or other
- Study start
- 1 Jun 2021 (estimated)
- Primary completion
- 30 Jan 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 19 May 2021 (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.
Randomized, open, single-center, controlled prospective studies were designed to obtain reliable level I evidence in evidence-based medicine.Based on the premise of at least a 6-fold reduction in pancreatic fistula, as observed by Kawai et al after early drainage.Considering the overall incidence of pancreatic fistula after standard pancreatectomy at our center (approximately 20%), we would expect this complication to occur in approximately 3.4% of cases in Group A.α was set as 0.05 and β was set as 0.2 (efficacy was 80%), indicating that the total number of study subjects was at least 114 patients (at least 57 patients in the experimental group and 57 patients in the control group).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort A | – | Device: drainage tube was removed on 5th days after surgery.The drainage tube was removed on the 5th day after surgery. |
| Cohort B | – | Device: drainage tube was removed on 7th days after surgery.The drainage tube was removed on the 7th day after surgery. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Prepare for elective pancreatic surgery, including laparoscopic or open pancreaticoduodenectomy and distal pancreaticocaudal body resection;
Key inclusion criteria (5 listed)
- ECOG 0-2;
- The amylase value in the drainage tube of patients receiving pancreaticoduodenectomy or distal pancreatectomy was lower than 5000 IU/L on the first day after surgery;
- postoperative drainage tube placement;
- Patients with no obvious contraindication to surgery;
- Expected postoperative survival ≥3 months;
Key exclusion criteria (4 listed)
- Pancreaticoduodenectomy and pancreaticogastric anastomosis were performed;
- Suspicion or abdominal bleeding within 5 days after surgery;
- suspected biliary and intestinal fistula within 5 days after operation;
- On the fifth day after the operation, abdominal CT reexamination showed local effusion with a depth greater than 3cm.
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 |
|---|---|---|
| drainage tube was removed on 5th days after surgery.drainage tube was removed on 5th days after surgery. | Device | Cohort A |
| drainage tube was removed on 7th days after surgery.drainage tube was removed on 7th days after surgery. | Device | Cohort B |
Primary outcome
The incidence of postoperative pancreatic fistula and abdominal infection;
Time frame: 3month
Severity of complications (duration of postoperative hospital stay) was assessed by Dindo Clavien classification.
Time frame: 3month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2021.
- 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.
Xianjun F Yu principal investigator
Fudan 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 Safety Issues, run by Xian-Jun Yu 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 5 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: status not confirmed, as of the sponsor's last update on 19 May 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xianjun F Yu (18019112906, yuxianjun@fudanpci.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of postoperative pancreatic fistula and abdominal infection; (time frame: 3month). 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?
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 19 May 2021.