Risk Scoring System for Prediction of Pancreatic Fistula Post PDNCT05654636
Evaluation of Sun's Scoring System Use in Post-pancraticodoudenectomy Pancreatic Fistula
An observational study of Risk Scoring System for Prediction of Pancreatic Fistula Post PD, run by Assiut University.
Trial summary
Evaluation of sun scoring system for predication of pancreatic fistula after Pancreaticoduodenectomy to facilitate timely intervention after Pancreaticoduodenectomy. Read more about this study
- Who is it for?
- Ages 25 to 70 years
- Conditions the study is for
- Risk Scoring System for Prediction of Pancreatic Fistula Post PD
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2023to Mar 2025
- 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 25 to 70 years
- All sexes
- Adult, Older adult
Study population: All patients admitted to Assuit university hospitals which candidate for pancreaticoduodenectomy at the time of the study.
Who may be able to join
- All the cases indicated for Pancreaticoduedenectomy with :
- age less than 70 years.
- resectable tumour,
- fitness patients
Who cannot join
- 1_patients with jaundice with serum bilirubin above 200mml/dl. 2_patients with bleeding tendency until corrected. 3_patients with advanced and metastatic malignancy. 4_patients with cardiopulmonary diseases.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Evaluation of Sun's Scoring System Use in Post-pancraticodoudenectomy Pancreatic Fistula; an Observational Cohort Study.
Evaluation of sun scoring system for predication of pancreatic fistula after Pancreaticoduodenectomy to facilitate timely intervention after Pancreaticoduodenectomy.
Read the detailed description
Pancreaticoduodenectomy is the only option curative intended in the treatment of resectable pancreatic ductal adenocarcinomas, duodenal carcinoma, ampullary carcinoma, lower common bile duct cholangiocarcinoma,. It is still associated with very high morbidity and mortality. [1]. Pancreatic cancer ranks as the seventh leading cause of cancer-related death worldwide, and the fourth among other cancers[2,3]. Pancreatic fistula(PF) is one of the most important complications after Pancreaticoduodenectomy, with an incidence of about 10% to 28%.[4].There are multiple risk factors for the predication of development of pancreatic fistula after pancreaticoduodenectomy which include soft gland texture, non-pancreatic cancer non-chronic pancreatitis pathology, small pancreatic duct diameter (<3 mm), and high intraoperative blood loss (>1000 mL) , excess intraoperative fluid administration and increased pancreatic parenchymal remnant volume [5,6,7]. Other reported risk factors as increased body mass index (BMI), poor preoperative nutrition, and male gender which preoperative may lead to pancreatic fistula [8.9]. Recent studies are deficient in evaluation and predication of pancreatic fistula . So the interest of our study to evaluate and predicate the risk factors and management of pancreatic fistula after Pancreaticoduodenectomy .
What is being measured
The primary outcome is the main question the study is designed to answer.
predication of pancreatic fistula after Pancreaticoduodenectomy to facilitate timely intervention after Pancreaticoduodenectomy
Early prediction of pancreatic fistula post PD facilities threraputic intervention and life saving in some cases
Measured: Baseline
Secondary outcomes (1)
Reduce the morbidity and mortality and improve the quality after pancraticoduodenectomy
Management of pancreatic fistula post PD improve quality of life
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2022
- Study start1 Jan 2023 (estimated)
- Primary completionJan 2025 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Risk Scoring System for Prediction of Pancreatic Fistula Post PDStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Saber Mekhemer, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05654636
- Sponsor's protocol ID
- Pancreatic fistula post PD
- Status last verified
- Dec 2022
- First submitted
- 8 Dec 2022
- Last updated
- 16 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Li Y, Zhou F, Zhu DM, Zhang ZX, Yang J, Yao J, Wei YJ, Xu YL, Li DC, Zhou J. Novel risk scoring system for prediction of pancreatic fistula after pancreaticoduodenectomy. World J Gastroenterol. 2019 Jun 7;25(21):2650-2664. doi: 10.3748/wjg.v25.i21.2650.
PubMed 31210716Chen JY, Feng J, Wang XQ, Cai SW, Dong JH, Chen YL. Risk scoring system and predictor for clinically relevant pancreatic fistula after pancreaticoduodenectomy. World J Gastroenterol. 2015 May 21;21(19):5926-33. doi: 10.3748/wjg.v21.i19.5926.
PubMed 26019457Xia W, Zhou Y, Lin Y, Yu M, Yin Z, Lu X, Hou B, Jian Z. A Predictive Risk Scoring System for Clinically Relevant Pancreatic Fistula After Pancreaticoduodenectomy. Med Sci Monit. 2018 Aug 16;24:5719-5728. doi: 10.12659/MSM.911499.
PubMed 30113999
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Sun's Scoring System Use in Post-pancraticodoudenectomy Pancreatic Fistula; an Observational Cohort Study.
- ClinicalTrials.gov ID
- NCT05654636
- Acronym / sponsor ID
- Pancreatic fistula post PD
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (estimated)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 16 Dec 2022 (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.
Evaluation of sun scoring system for predication of pancreatic fistula after Pancreaticoduodenectomy to facilitate timely intervention after Pancreaticoduodenectomy.
Detailed description
Pancreaticoduodenectomy is the only option curative intended in the treatment of resectable pancreatic ductal adenocarcinomas, duodenal carcinoma, ampullary carcinoma, lower common bile duct cholangiocarcinoma,. It is still associated with very high morbidity and mortality. [1]. Pancreatic cancer ranks as the seventh leading cause of cancer-related death worldwide, and the fourth among other cancers[2,3]. Pancreatic fistula(PF) is one of the most important complications after Pancreaticoduodenectomy, with an incidence of about 10% to 28%.[4].There are multiple risk factors for the predication of development of pancreatic fistula after pancreaticoduodenectomy which include soft gland texture, non-pancreatic cancer non-chronic pancreatitis pathology, small pancreatic duct diameter (<3 mm), and high intraoperative blood loss (>1000 mL) , excess intraoperative fluid administration and increased pancreatic parenchymal remnant volume [5,6,7]. Other reported risk factors as increased body mass index (BMI), poor preoperative nutrition, and male gender which preoperative may lead to pancreatic fistula [8.9]. Recent studies are deficient in evaluation and predication of pancreatic fistula . So the interest of our study to evaluate and predicate the risk factors and management of pancreatic fistula after Pancreaticoduodenectomy .
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All patients admitted to Assuit university hospitals which candidate for pancreaticoduodenectomy at the time of the study.
Key inclusion criteria (4 listed)
- All the cases indicated for Pancreaticoduedenectomy with :
Key exclusion criteria (1 listed)
- 1_patients with jaundice with serum bilirubin above 200mml/dl. 2_patients with bleeding tendency until corrected. 3_patients with advanced and metastatic malignancy. 4_patients with cardiopulmonary diseases.
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
predication of pancreatic fistula after Pancreaticoduodenectomy to facilitate timely intervention after Pancreaticoduodenectomy
Time frame: Baseline
Early prediction of pancreatic fistula post PD facilities threraputic intervention and life saving in some cases
1 secondary outcome
Reduce the morbidity and mortality and improve the quality after pancraticoduodenectomy
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2022.
- Background: PubMed 31210716Li Y, Zhou F, Zhu DM, Zhang ZX, Yang J, Yao J, Wei YJ, Xu YL, Li DC, Zhou J. Novel risk scoring system for prediction of pancreatic fistula after pancreaticoduodenectomy. World J Gastroenterol. 2019 Jun 7;25(21):2650-2664. doi: 10.3748/wjg.v25.i21.2650.
- Background: PubMed 26019457Chen JY, Feng J, Wang XQ, Cai SW, Dong JH, Chen YL. Risk scoring system and predictor for clinically relevant pancreatic fistula after pancreaticoduodenectomy. World J Gastroenterol. 2015 May 21;21(19):5926-33. doi: 10.3748/wjg.v21.i19.5926.
- Background: PubMed 30113999Xia W, Zhou Y, Lin Y, Yu M, Yin Z, Lu X, Hou B, Jian Z. A Predictive Risk Scoring System for Clinically Relevant Pancreatic Fistula After Pancreaticoduodenectomy. Med Sci Monit. 2018 Aug 16;24:5719-5728. doi: 10.12659/MSM.911499.
- Individual participant dataSharing planned: Undecided
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Risk Scoring System for Prediction of Pancreatic Fistula Post PD, run by Assiut University.
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 4 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: status not confirmed, as of the sponsor's last update on 16 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
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 Mahmoud Saber Mekhemer, Resident (01141608732, mahmoud.saber.3291@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
predication of pancreatic fistula after Pancreaticoduodenectomy to facilitate timely intervention after Pancreaticoduodenectomy (time frame: Baseline). 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 NCT05654636, which also lists 3 linked publications.
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 16 Dec 2022.