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Role of DIA in Diagnosing Nature of Indeterminate Biliary Duct Stricture

Role of Digital Image Analysis in Diagnosing Nature of Indeterminate Biliary Duct Stricture

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04112030
Enrollment
50
Registered
2019-10-02
Start date
2016-10-31
Completion date
2018-03-31
Last updated
2019-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bile Duct Stricture

Brief summary

The study aimed to assess role of DIA in diagnosing nature of indeterminate bile ducts stricture

Detailed description

Biliary strictures (BSs) are common in clinical practice, but differentiating nature of the stricture either benign or malignant remains a challenge. Although there is a great advance in imaging and laboratory investigations, nature of BS is still unclear in some patients. Therefore, preoperative evaluation of such strictures is mandatory to put suitable plan with appropriate management. BS is considered indeterminate biliary duct stricture (IBDS) if it has the following conditions; 1) no obvious mass on abdominal ultrasound (US), or magnetic resonance cholangiopancreatography (MRCP); 2) no distant metastasis on abdominal US, or MRI; and 3) no recent history of hepatobiliary surgery in the last 3 months. IBDS has a particularly complex challenge, because patients and their physicians must weigh the malignant potential against benign etiologies in the face of morbidity of surgical intervention. About 15-24% of the patients had surgical intervention for suspected IBDS have a benign aetiology. Therefore, preoperative evaluation of such strictures is mandatory to put suitable plan with appropriate management. Conventional cytological evaluation (CCE) has become the standard modality of practice for the investigation of such stricture. CCE had low diagnostic yield with an overall sensitivity of 41.6% and a negative predictive value of 58%. This low diagnostic yield is mainly attributed to desmoplastic reaction in BS. Radiological elevation of BS with different modalities as MRCP enables us to detect the stricture and its extent and exclude other causes of obstruction. These modalities fail to determine nature of BS in many cases. In addition to, inability to take tissue sampling or perform therapeutic intervention. Recently, there is a great advance in endoscopic assessment of BS as cholangioscopy, intraductal ultrasonography (IDUS), and confocal laser endomicroscopy. These techniques have high diagnostic yield in diagnosing nature of BS but secondary to high cost, complexity, and unavailability of these procedures, making them of limited use in evaluation the nature of IBDS. Advanced cytological techniques have been emerged to identify nature of IBDS i.e., digital image analysis (DIA), and fluorescence in-situ hybridization (FISH) where both techniques detect the chromosomal alterations in malignant cells. FISH is significantly more sensitive than CCE for assessment the nature of IBDS. However, the specificity of FISH was poor compared to the excellent specificity of CCE. The compromised specificity of FISH may limit its utility in the detection of nature of IBDS. DIA has been widely used in many malignant diseases, especially in cervical cancer where it had 70% to 91.7%, sensitivity and 54.1% to 100% specificity for the diagnosis of different malignant diseases in published studies. Role of DIA in pancreatobiliary malignancies is still controversial. Also, there are limited studies that have addressed the use of DIA in diagnosing the nature of IBDS. In addition to unavailability, the high cost and the complexity of advanced endoscopes, we designed this work to evaluate the diagnostic performance of DIA in identification nature of IBDS in comparison to CCE. Also, we perform a cost analysis of DIA vs. CCE in diagnosing nature of IBDS.

Interventions

DIAGNOSTIC_TESTDigital image analysis

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Any patient presented with biliary stricture with no obvious cause in abdominal imaging

Exclusion criteria

* biliary obstruction due to other causes as stones, or tumor, * biliary surgery within the last six months * Coagulopathy * lost follow up

Design outcomes

Primary

MeasureTime frameDescription
Diagnostic performance of DIA compared to routine cytology in case of IBDSBaselineall samples were subjected to DIA and routine cytology and the result was compared with final diagnosis

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026