Pancreatic FistulaNCT05017207
Clinically Relevant Pancreatic Fistula After Pancreaticoduodenectomy
An observational study of Pancreatic Fistula, run by Vo Truong Quoc at 1 site in Vietnam.
Trial summary
Patients who are diagnosed with periampullary cancer will be performed pancreaticoduodenectomy with 3 types of pancreatic-jejunal anastomosis reconstructions. The investigator will analysis the complication of pancreatic fistula about: the clinical symptoms, laboratory test changing, intra-operative morphology, the… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pancreatic Fistula
- What is being tested?
- Pancreaticoduodenectomy
- Type of treatment
- Surgery or procedure
- How many people
- 183 participants
- Where
- 1 siteVietnam
- Study dates
- 1 Aug 2021to 31 Oct 2023
- How long will I take part?
- 90 Days
- 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 75 years
- All sexes
- Adult, Older adult
Study population: Periampullary cancer with postoperative pathology is adenocarcinoma
Who may be able to join
- Patient with periampullary cancer and can be performed pancreaticoduodenectomy.
- Pancreaticoduodenectomy with one of three types of pancreatic - duodenal anastomosis reconstructions.
Who cannot join
- The patient does not consent to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinically Relevant Postoperative Pancreatic Fistula After Pancreaticoduodenectomy for Periampullary Cancer and Risk Factors: A Prospective Multicenter Study
Patients who are diagnosed with periampullary cancer will be performed pancreaticoduodenectomy with 3 types of pancreatic-jejunal anastomosis reconstructions. The investigator will analysis the complication of pancreatic fistula about: the clinical symptoms, laboratory test changing, intra-operative morphology, the risk factors
Read the detailed description
This study will conduct at two centers at the same time: University of Medicine and Pharmacy Center and Cho Ray Hospital. The patients will be consulted to participate to this research from September, 2021 to April, 2023.
Plan for conducting study:
- The investigator consults and gets consensus form of the patient with periampullary cancer.
- The patient will be prepared for pancreaticoduodenectomy: pre-operative laboratory test, pre-operative biliary drainage, anesthetic checking.
- The investigator collected intr-operative data, include type of pancreatic-duodenal reconstruction, type of pancreatic duct's drainage, quantity of blood loss and blood transfusion.
- The investor follows post-operative period.
- If there are pancreatic fistula appear, the investigator will collect the clinical signs, laboratory test changing, re-operative morphology.
- The investigator analysis the risk factors of pancreatic fistula.
Data analysis:
- To determine the incidence of pancreatic fistula, the morphology of pancreatic fistula, descriptive statistics will be used.
- To determine the risk factors of pancreatic fistula, logistic regression will be used.
Sample size:
- The investigator plans to collect 145 patients in the research period.
Plan for missing data:
- Any case that miss information will be removed from the study.
- Conditions
- Pancreatic Fistula
- Being tested
- Pancreaticoduodenectomy
- Keywords
- Risk factor
- Medical subject headings
- Pancreatic Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PancreaticoduodenectomyProcedure or surgery
Pancreaticoduodenectomy with one of 2 types of pancreaticojejunal anastomosis: Blumgart and conventional duct-to-mucosa
| Study group | Role | What they receive |
|---|---|---|
| Patient with periampullary cancer and pancreaticoduodenectomy | Only one group of patient with periampullary cancer Receives: Procedure: Pancreaticoduodenectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pancreatic fistula
The investigator will describe the day that appears pancreatic fistula, the clinical symptoms, intra-operative morphology if being indicated to re-operate. The measurement tool to diagnose pancreatic fistula is fluid amylase on the POD3 (fluid amylse is 3 times compared to serum's amylase)
Measured: 30 days of post-operative period
Risk factors relate to pancreatic fistula
The investigator will analyse some of the risk factors that relate to pancreatic fistula, including pre-operative factors (BMI, albumin, bilirubin, biliary drainage), intra-operative elements (pancreatic duct 's diameter, pancreatic textile, blood transfusion, portal vein reconstruction), and post-operative factors (abdominal drainage's volume, fluid amylase, abdominal abscess..). The investigator will use the multivariable regression model to determine the risk factors (p-value<0.05)
Measured: 30 days of post-operative period
Secondary outcomes (1)
Short-term result in treatment of post-operative pancreatic fistula
The investigator will describe the result of pancreatic fistula treatment: intra-operative morphology, re-operative success ratio, morbidities.
Measured: 30 days of post-operatvive period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2021
- Study start1 Aug 2021
- Primary completion31 Oct 2023
- Study completion31 Oct 2023
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 Pancreatic FistulaStudies 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
- 183 participants (actual)
- Target duration
- 90 Days
Sponsor and investigators
- Lead sponsor
- Vo Truong Quoc
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Vo Truong Quoc, University of Medicine and Pharmacy at Ho Chi Minh City
- Investigators
- Truong Quoc Vo, Principal investigator, University of Medicine and Pharmacy at HoChiMinh City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05017207
- Sponsor's protocol ID
- Trquoc
- Status last verified
- May 2024
- First submitted
- 6 Aug 2021
- Last updated
- 17 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The IDP will be saved as excel and spss file
Publications
Kawaida H, Kono H, Hosomura N, Amemiya H, Itakura J, Fujii H, Ichikawa D. Surgical techniques and postoperative management to prevent postoperative pancreatic fistula after pancreatic surgery. World J Gastroenterol. 2019 Jul 28;25(28):3722-3737. doi: 10.3748/wjg.v25.i28.3722.
PubMed 31391768
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinically Relevant Postoperative Pancreatic Fistula After Pancreaticoduodenectomy for Periampullary Cancer and Risk Factors: A Prospective Multicenter Study
- ClinicalTrials.gov ID
- NCT05017207
- Acronym / sponsor ID
- Trquoc
- Conditions
- Pancreatic Fistula
- Keywords
- Risk factor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 183 participants (actual)
- Lead sponsor
- Vo Truong QuocUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 23 Aug 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.
Patients who are diagnosed with periampullary cancer will be performed pancreaticoduodenectomy with 3 types of pancreatic-jejunal anastomosis reconstructions. The investigator will analysis the complication of pancreatic fistula about: the clinical symptoms, laboratory test changing, intra-operative morphology, the risk factors
Detailed description
This study will conduct at two centers at the same time: University of Medicine and Pharmacy Center and Cho Ray Hospital. The patients will be consulted to participate to this research from September, 2021 to April, 2023.
Plan for conducting study:
- The investigator consults and gets consensus form of the patient with periampullary cancer.
- The patient will be prepared for pancreaticoduodenectomy: pre-operative laboratory test, pre-operative biliary drainage, anesthetic checking.
- The investigator collected intr-operative data, include type of pancreatic-duodenal reconstruction, type of pancreatic duct's drainage, quantity of blood loss and blood transfusion.
- The investor follows post-operative period.
- If there are pancreatic fistula appear, the investigator will collect the clinical signs, laboratory test changing, re-operative morphology.
- The investigator analysis the risk factors of pancreatic fistula.
Data analysis:
- To determine the incidence of pancreatic fistula, the morphology of pancreatic fistula, descriptive statistics will be used.
- To determine the risk factors of pancreatic fistula, logistic regression will be used.
Sample size:
- The investigator plans to collect 145 patients in the research period.
Plan for missing data:
- Any case that miss information will be removed from the study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 90 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient with periampullary cancer and pancreaticoduodenectomy | – | Procedure: PancreaticoduodenectomyOnly one group of patient with periampullary cancer |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Periampullary cancer with postoperative pathology is adenocarcinoma
Key inclusion criteria (2 listed)
- Patient with periampullary cancer and can be performed pancreaticoduodenectomy.
- Pancreaticoduodenectomy with one of three types of pancreatic - duodenal anastomosis reconstructions.
Key exclusion criteria (1 listed)
- The patient does not consent to participate in the study
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 |
|---|---|---|
| PancreaticoduodenectomyPancreaticoduodenectomy with one of 2 types of pancreaticojejunal anastomosis: Blumgart and conventional duct-to-mucosa | Procedure or surgery | Patient with periampullary cancer and pancreaticoduodenectomy |
Primary outcome
Pancreatic fistula
Time frame: 30 days of post-operative period
The investigator will describe the day that appears pancreatic fistula, the clinical symptoms, intra-operative morphology if being indicated to re-operate. The measurement tool to diagnose pancreatic fistula is fluid amylase on the POD3 (fluid amylse is 3 times compared to serum's amylase)
Risk factors relate to pancreatic fistula
Time frame: 30 days of post-operative period
The investigator will analyse some of the risk factors that relate to pancreatic fistula, including pre-operative factors (BMI, albumin, bilirubin, biliary drainage), intra-operative elements (pancreatic duct 's diameter, pancreatic textile, blood transfusion, portal vein reconstruction), and post-operative factors (abdominal drainage's volume, fluid amylase, abdominal abscess..). The investigator will use the multivariable regression model to determine the risk factors (p-value<0.05)
1 secondary outcome
Short-term result in treatment of post-operative pancreatic fistula
Time frame: 30 days of post-operatvive period
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 17 May 2024.
- Background: PubMed 31391768Kawaida H, Kono H, Hosomura N, Amemiya H, Itakura J, Fujii H, Ichikawa D. Surgical techniques and postoperative management to prevent postoperative pancreatic fistula after pancreatic surgery. World J Gastroenterol. 2019 Jul 28;25(28):3722-3737. doi: 10.3748/wjg.v25.i28.3722.
- Surgical techniques and postoperative management to prevent postoperative pancreatic fistula after pancreatic surgeryLink provided by the sponsor.
- Individual participant dataSharing planned: No. The IDP will be saved as excel and spss file
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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.
Truong Quoc Vo principal investigator
University of Medicine and Pharmacy at HoChiMinh City
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 Pancreatic Fistula, run by Vo Truong Quoc at 1 site in Vietnam.
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 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 17 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 Vietnam. 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?
Pancreatic fistula (time frame: 30 days of post-operative period). 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 NCT05017207, 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 17 May 2024.