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Evaluation of Sun's Scoring System Use in Post-pancraticodoudenectomy Pancreatic Fistula

NCT ID: NCT05654636

Last Updated: 2022-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-01

Study Completion Date

2025-03-31

Brief Summary

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Evaluation of sun scoring system for predication of pancreatic fistula after Pancreaticoduodenectomy to facilitate timely intervention after Pancreaticoduodenectomy.

Detailed Description

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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 .

Conditions

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Risk Scoring System for Prediction of Pancreatic Fistula Post PD

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* All the cases indicated for Pancreaticoduedenectomy with :

1. age less than 70 years.
2. resectable tumour,
3. fitness patients

Exclusion Criteria

* 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.
Minimum Eligible Age

25 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Mahmoud Saber Mekhemer

Evaluation of Sun's scoring system use in post-pancraticodoudenectomy pancreatic fistula; an observational cohort study

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Mahmoud Saber Mekhemer, Resident

Role: CONTACT

Phone: 01141608732

Email: [email protected]

Salah Ibrahim Mohamad, MD

Role: CONTACT

Phone: 01061616104

Email: [email protected]

References

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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.

Reference Type BACKGROUND
PMID: 31210716 (View on PubMed)

Chen 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.

Reference Type BACKGROUND
PMID: 26019457 (View on PubMed)

Xia 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.

Reference Type BACKGROUND
PMID: 30113999 (View on PubMed)

Other Identifiers

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Pancreatic fistula post PD

Identifier Type: -

Identifier Source: org_study_id