Acute PancreatitisNCT07322978
Incidence of Splanchnic Venous Thrombosis in Acute Pancreatitis and it's Correlation With Severity of Pancreatitis
An observational study of Acute Pancreatitis, run by Asian Institute of Gastroenterology, India at 1 site in India.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Acute Pancreatitis
- How many people
- 500 participants
- Where
- 1 siteIndia
- Study dates
- 27 Feb 2025to 27 Feb 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 85 years
- All sexes
- Adult, Older adult
Study population: All in-patients with acute pancreatitis, getting admitted from emergency or OPD will be enrolled. Only when a study subject has given informed consent, clinical data will be recorded
Who may be able to join
- Patients aged between 18-85 years of age.
- Diagnosis of AP as per international consensus criteria.
Who cannot join
- Chronic pancreatitis.
- Established malignancy.
- Cirrhosis of liver or established portal hypertension.
- Pregnancy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
India1 site, 1 recruiting
- Recruiting
AIG Hospital
Hyderabad, Telangana, 500032
Dr. Sharath Sitaram, DrNB, +91 8197016905, sharath.sitaram@gmail.com
About this study
Official title: Incidence of Splanchnic Venous Thrombosis in Acute Pancreatitis and it's Correlation With Severity of Pancreatitis - a Prospective Observational Study
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
Read the 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.
- Conditions
- Acute Pancreatitis
- Medical subject headings
- Pancreatitis
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcome
Detection of thrombus in splenic, superior mesenteric or portal vein.
Measured: 1 year
Secondary outcomes (4)
Secondary Outcome
Correlation of splanchnic venous thrombosis with severity of acute pancreatitis.
Measured: 1 year
Secondary Outcome
Incidence of infected pancreatic necrosis/ peri-pancreatic fluid collections in patients with acute pancreatitis having SVT.
Measured: 1 year
Secondary Outcome
Effect of drainage of peripancreatic fluid collections/ necrotic collections on status of thrombosis.
Measured: 1 year
Secondary Outcome
Vessel recanalization on follow-up at 6 months
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2026
- Study start27 Feb 2025
- Primary completion27 Feb 2026 (estimated)
- Study completion27 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute PancreatitisStudies of the same condition, open and under way.
- More trials run by Asian Institute of Gastroenterology, IndiaThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asian Institute of Gastroenterology, India
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07322978
- Sponsor's protocol ID
- SVT in AP-01
- Status last verified
- Feb 2025
- First submitted
- 2 Apr 2025
- Last updated
- 7 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Splanchnic Venous Thrombosis in Acute Pancreatitis and it's Correlation With Severity of Pancreatitis - a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07322978
- Acronym / sponsor ID
- SVT in AP-01
- Conditions
- Acute Pancreatitis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Asian Institute of Gastroenterology, IndiaUniversity, hospital or other
- Study start
- 27 Feb 2025 (actual)
- Primary completion
- 27 Feb 2026 (estimated)
- Study completion
- 27 Feb 2026 (estimated)
- First posted
- 7 Jan 2026 (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.
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
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All in-patients with acute pancreatitis, getting admitted from emergency or OPD will be enrolled. Only when a study subject has given informed consent, clinical data will be recorded
Key inclusion criteria (2 listed)
- Patients aged between 18-85 years of age.
- Diagnosis of AP as per international consensus criteria.
Key exclusion criteria (4 listed)
- Chronic pancreatitis.
- Established malignancy.
- Cirrhosis of liver or established portal hypertension.
- Pregnancy.
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
Primary outcome
Time frame: 1 year
Detection of thrombus in splenic, superior mesenteric or portal vein.
4 secondary outcomes
Secondary Outcome
Time frame: 1 year
Secondary Outcome
Time frame: 1 year
Secondary Outcome
Time frame: 1 year
Secondary Outcome
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Pancreatitis, run by Asian Institute of Gastroenterology, India at 1 site in India.
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 2 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sharath Sitaram, MBBS, DNB (8197016905, sharath.sitaram@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary outcome (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Jan 2026.