PancreaticoduodenectomyNCT03791450
Investigation of Pancreaticoduodenectomy
An observational study of Pancreaticoduodenectomy, run by Tongji Hospital at 1 site in China.
Trial summary
The investigators intend to conduct a multicentre, big-sample, retrospective study to analysis the surgery results of pancreaticoduodenectomy and compare the different suture technique. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pancreaticoduodenectomy
- How many people
- 10,085 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2019to 1 Aug 2019
- 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 had underwent pancreaticoduodenectomy between 2008 to 2018.
Who may be able to join
- Patients who had underwent pancreaticoduodenectomy between 2008 to 2018.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
China1 site
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030
About this study
Official title: A Multicenter Big⁃Sample Retrospective Study of Pancreaticoduodenectomy
The investigators intend to conduct a multicentre, big-sample, retrospective study to analysis the surgery results of pancreaticoduodenectomy and compare the different suture technique.
Read the detailed description
For patients with malignant or benign disease of the pancreatic head and periampullary region, pancreaticoduodenectomy is the only potential approach to radical cure. However, pancreaticoduodenectomy is consider as one of the most complex operations associated with a high rate of postoperative complications such as pancreatic fistula, delayed gastric emptying, hemorrhage, abscess, and sepsis. These complications increase the costs associated with pancreaticoduodenectomy. Numerous interventions and techniques have been introduced to decrease the morbidity. But there is little evidence for the superiority of one anastomotic technique over the others. Therefore, investigators intend to conduct a multicentre, big-sample, retrospective study to analysis the surgery results of pancreaticoduodenectomy and compare the different suture technique.
- Conditions
- Pancreaticoduodenectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| pancreaticoduodenectomy | patients underwent pancreaticoduodenectomy in recent ten years. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Postoperative Pancreatic Fistula(POPF)
The frequency of POPF occurs and the POPF will be strictly diagnosis and classified according to IGSPF criteria.
Measured: Within 30 days after surgery
Secondary outcomes (5)
Morbidity
The incidence of operative complications within 90 days after surgery
Measured: Within 90 days after surgery
Mortality
The death occurred within 30 days after surgery
Measured: Within 30 days after surgery
Duration of operation
The time of operation count by minute.
Measured: Intraoperative
Length of hospital stay after surgery
Days between surgery and hospital discharge
Measured: From first day after surgery to release from hospital (anticipate 5 days minimally)
Hospital costs
The total hospitalization expenses
Measured: From first day after surgery to release from hospital (anticipate 5 days minimally)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2019
- Study start1 Mar 2019
- Primary completion1 Aug 2019
- Study completion1 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PancreaticoduodenectomyStudies of the same condition, open and under way.
- More trials run by Tongji 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
- 10,085 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chen Xiaoping, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03791450
- Sponsor's protocol ID
- C201812
- Status last verified
- Mar 2020
- First submitted
- 21 Dec 2018
- Last updated
- 4 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Big⁃Sample Retrospective Study of Pancreaticoduodenectomy
- ClinicalTrials.gov ID
- NCT03791450
- Acronym / sponsor ID
- C201812
- Conditions
- Pancreaticoduodenectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10,085 participants (actual)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 1 Aug 2019 (actual)
- Study completion
- 1 Aug 2019 (actual)
- First posted
- 2 Jan 2019 (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 investigators intend to conduct a multicentre, big-sample, retrospective study to analysis the surgery results of pancreaticoduodenectomy and compare the different suture technique.
Detailed description
For patients with malignant or benign disease of the pancreatic head and periampullary region, pancreaticoduodenectomy is the only potential approach to radical cure. However, pancreaticoduodenectomy is consider as one of the most complex operations associated with a high rate of postoperative complications such as pancreatic fistula, delayed gastric emptying, hemorrhage, abscess, and sepsis. These complications increase the costs associated with pancreaticoduodenectomy. Numerous interventions and techniques have been introduced to decrease the morbidity. But there is little evidence for the superiority of one anastomotic technique over the others. Therefore, investigators intend to conduct a multicentre, big-sample, retrospective study to analysis the surgery results of pancreaticoduodenectomy and compare the different suture technique.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pancreaticoduodenectomy | – | –patients underwent pancreaticoduodenectomy in recent ten years. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who had underwent pancreaticoduodenectomy between 2008 to 2018.
Key inclusion criteria (1 listed)
- Patients who had underwent pancreaticoduodenectomy between 2008 to 2018.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of Postoperative Pancreatic Fistula(POPF)
Time frame: Within 30 days after surgery
The frequency of POPF occurs and the POPF will be strictly diagnosis and classified according to IGSPF criteria.
5 secondary outcomes
Morbidity
Time frame: Within 90 days after surgery
Mortality
Time frame: Within 30 days after surgery
Duration of operation
Time frame: Intraoperative
Length of hospital stay after surgery
Time frame: From first day after surgery to release from hospital (anticipate 5 days minimally)
Hospital costs
Time frame: From first day after surgery to release from hospital (anticipate 5 days minimally)
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 4 Mar 2020.
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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 Pancreaticoduodenectomy, run by Tongji 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 4 Mar 2020. 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?
Incidence of Postoperative Pancreatic Fistula(POPF) (time frame: Within 30 days after 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 4 Mar 2020.