- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07322978
Incidence of Splanchnic Venous Thrombosis in Acute Pancreatitis and it's Correlation With Severity of Pancreatitis
Incidence of Splanchnic Venous Thrombosis in Acute Pancreatitis and it's Correlation With Severity of Pancreatitis - a Prospective Observational Study
Study Overview
Status
Conditions
Detailed Description
Acute pancreatitis (AP) is a common medical condition characterized by inflammation of the pancreas, affecting a significant portion of the population. With approximately one-third of patients experiencing notable morbidity due to local or systemic complications, the severity of the disease is underscored by the presence of acute peripancreatic fluid collections, acute necrotic collections, pseudocysts, and walled-off necrosis1. Notably, vascular complications, such as splanchnic vein thrombosis, further contribute to the increased morbidity and mortality associated with acute pancreatitis2. Splanchnic vein thrombosis encompasses thromboses in the splenic (SpVT), portal (PVT), and superior mesenteric veins (SMVT), either individually or in combination3. These complications are often incidentally discovered during imaging procedures conducted to assess potential complications4. Despite most cases being asymptomatic, fatal complications, including bowel ischemia, liver failure, portal hypertension, and life-threatening bleeding, have been documented, with the risk of splanchnic vein thrombosis escalating with the severity of pancreatitis.
The intricate relationship between the pancreas and large mesenteric vessels, coupled with systemic inflammatory responses, hypovolemia, fluid shifts, and prothrombotic states, contributes to the development of splanchnic vein thrombosis in acute pancreatitis5. Early detection of these thrombotic events becomes imperative to mitigate long-term sequelae such as portal hypertension and chronic mesenteric ischemia6. Despite the critical importance of identifying splanchnic vein thrombosis in acute pancreatitis, there is a notable absence of standardized recommendations for initiating anticoagulation treatment in these cases5. The decision-making process is further complicated by the potential risk of bleeding associated with other vascular complications, such as bleeding into pseudocysts or pseudo-aneurysmal bleeds7. As a result, there is a pressing need for more comprehensive studies that delve into the risk factors, pathogenesis, therapeutic impacts, and outcome predictors associated with splanchnic vein thrombosis in the context of acute pancreatitis. These investigations will not only enhance our understanding of the condition but also inform the development of evidence-based guidelines for the management of splanchnic vein thrombosis in individuals with acute pancreatitis.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Sharath Sitaram, MBBS, DNB
- Phone Number: 8197016905
- Email: sharath.sitaram@gmail.com
Study Locations
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Telangana
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Hyderabad, Telangana, India, 500032
- Recruiting
- AIG hospital
-
Contact:
- Dr. Sharath Sitaram, DrNB
- Phone Number: +91 8197016905
- Email: sharath.sitaram@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients aged between 18-85 years of age.
- Diagnosis of AP as per international consensus criteria.
Exclusion Criteria:
- Chronic pancreatitis.
- Established malignancy.
- Cirrhosis of liver or established portal hypertension.
- Pregnancy.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Primary outcome
Time Frame: 1 year
|
Detection of thrombus in splenic, superior mesenteric or portal vein.
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Secondary Outcome
Time Frame: 1 year
|
Correlation of splanchnic venous thrombosis with severity of acute pancreatitis.
|
1 year
|
|
Secondary Outcome
Time Frame: 1 year
|
Incidence of infected pancreatic necrosis/ peri-pancreatic fluid collections in patients with acute pancreatitis having SVT.
|
1 year
|
|
Secondary Outcome
Time Frame: 1 year
|
Effect of drainage of peripancreatic fluid collections/ necrotic collections on status of thrombosis.
|
1 year
|
|
Secondary Outcome
Time Frame: 6 months
|
Vessel recanalization on follow-up at 6 months
|
6 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SVT in AP-01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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