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Evaluation of (Surgery and Endoscopy) in Management of Indeterminate Common Bile Duct Stricture

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05138237
Recruitment Status : Recruiting
First Posted : November 30, 2021
Last Update Posted : November 30, 2021
Sponsor:
Information provided by (Responsible Party):
Mohamed Elsayed Abdelaal, Sohag University

Brief Summary:
Evaluate the lower indeterminate CBD strictures trying to reach possible diagnosis by all available methods i.e brush cytology ,bile aspirate cytology , tissue biopsy ,imaging studies and laboratory work up then treatment of the patient either endoscopically or surgically according to the etiology.

Condition or disease Intervention/treatment Phase
Indeterminate Common Bile Duct Stricture Procedure: endoscopy or surgery Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Evaluation of Different Modalities (Surgery and Endoscopy) in Management of Indeterminate Lower Common Bile Duct Stricture
Actual Study Start Date : August 1, 2021
Estimated Primary Completion Date : August 1, 2022
Estimated Study Completion Date : February 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Arm Intervention/treatment
Active Comparator: benign stricture
no of cases suspected to be benign by using the diagnostic tools "imaging , laboratory investigations , ERCP ,brushing ,cytology or histopathology"
Procedure: endoscopy or surgery
we choose the proper intervention "surgery or endoscopy" for management of the indeterminate common bile duct stricture according to its nature benign or malignant

Active Comparator: malignant stricture
no of cases suspected to be malignant by using the diagnostic tools "imaging , laboratory investigations , ERCP ,brushing ,cytology or histopathology"
Procedure: endoscopy or surgery
we choose the proper intervention "surgery or endoscopy" for management of the indeterminate common bile duct stricture according to its nature benign or malignant




Primary Outcome Measures :
  1. number of patients who are successfully treated of CBD strictures by endoscopy or by surgery [ Time Frame: follow up of the patient for 6 - 9 months ]
    dilatation or resection and shunt operation of CBD strictures allow continuity of the biliary system with good bile drainage

  2. reach a proper algorithm or scheme for management of the CBD stricture [ Time Frame: follow up of the patient for 6 - 9 months ]
    reach a proper algorithm or scheme to help in diagnosis of CBD strictures also, choose the proper method for treatment according to the nature and criteria of the CBD stricture


Secondary Outcome Measures :
  1. number of patients diagnosed by each method to measure accuracy and sensitivity of each method used in the study in diagnosis of biliary strictures [ Time Frame: follow up of the patient for 6 - 9 months ]
    comparing results with each method of diagnosis of CBD stricture



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • both sex
  • above age of 20 years old
  • patients presented with jaundice , pain and fever due to lower common bile duct stricture evident by abdominal imaging (Abdominal US ,MRCP) and confirmed by endoscopic retrograde cholangiopancreatography ( ERCP)
  • patients presented to sohag university hospital.

Exclusion Criteria:

  • Already diagnosed lower CBD strictures i.e known cause like visible pancreatic mass with visible metastasis or common bile duct stones.
  • Coagulopathy INR more than 1.5 or thrombocytopenia platelet less than 50,000/ml.
  • Proximal common bile duct stricture "above level of cystic duct".

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05138237


Contacts
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Contact: mohamed elsayed abdel aal, master degree general surgery 01009153537 dr_mabosdira@yahoo.com

Locations
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Egypt
Sohag Faculty of Medicine Recruiting
Sohag, Egypt
Contact: mohamed elsayed abdel aal, doctorate degree in g. surgery    01009153537    dr_mabosdira@yahoo.com   
Sponsors and Collaborators
Sohag University
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Responsible Party: Mohamed Elsayed Abdelaal, assistant lecturer of general surgery sohag faculty of medicine, Sohag University
ClinicalTrials.gov Identifier: NCT05138237    
Other Study ID Numbers: Soh-Med-21-10-30
First Posted: November 30, 2021    Key Record Dates
Last Update Posted: November 30, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mohamed Elsayed Abdelaal, Sohag University:
common bile duct stricture \ indeterminate
Additional relevant MeSH terms:
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Cholestasis
Constriction, Pathologic
Pathological Conditions, Anatomical
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases