Pancreatic NeoplasmsEUS-ENCT07139236
Preoperative EUS Elastography for Pancreatic Texture and POPF Prediction After PD
An observational study of Pancreatic Neoplasms and Pancreatic Fistula, run by Minia University at 1 site in Egypt.
Trial summary
This prospective study evaluates whether preoperative endoscopic ultrasound elastography (EUS-E) can predict pancreatic texture during surgery and risk of postoperative pancreatic fistula (POPF) in 100 patients undergoing pancreaticoduodenectomy. EUS-E measures pancreatic stiffness preoperatively. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pancreatic Neoplasms, Pancreatic Fistula
- What is being tested?
- Preoperative Endoscopic Ultrasound Elastography (EUS Elastography)
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2025to 16 Aug 2026
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population includes adults aged 18 and older scheduled for elective pancreaticoduodenectomy (PD) for resectable pancreatic head or periampullary diseases, such as pancreatic cancer, periampullary cancer, distal bile duct cancer and duodenal cancer. Patients must be medically fit for major surgery, with adequate organ function and physiological reserve, based on clinical and anesthesiology assessments. Exclusions apply to those with distant metastases, locally advanced unresectable tumors, prior pancreatic surgery, or chronic pancreatitis to avoid confounding tissue assessment. Patients often present with symptoms like jaundice or abdominal discomfort and are managed in specialized pancreatic centers with multidisciplinary care. This cohort is appropriate for evaluating preoperative endoscopic ultrasound elastography as a tool to predict intraoperative pancreatic texture and postoperative pancreatic fistula risk.
Who may be able to join
- Adult patients aged 18 years or older.
- Patients scheduled for elective pancreaticoduodenectomy (PD) due to pancreatic head or periampullary disease, including but not limited to:
- Pancreatic cancer (all stages eligible if resectable)
- Periampullary cancer
- Bile duct cancer
- Duodenal cancer
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- Patients deemed suitable for PD by the multidisciplinary pancreatic surgery team based on preoperative imaging and clinical evaluation.
- Adequate organ function and physiological reserve to undergo major abdominal surgery, as determined by clinical assessment and anesthesiology evaluation.
- Ability to provide written informed consent and comply with study procedures.
Who cannot join
- Evidence of distant metastases or locally advanced unresectable disease on preoperative imaging or clinical evaluation (e.g., liver metastases, peritoneal carcinomatosis, involvement of major vessels beyond resectability).
- Previous pancreatic surgery or total pancreatectomy.
- Chronic pancreatitis confirmed by clinical, radiological, or histological criteria that could confound pancreatic stiffness assessment.
- Severe comorbidities or American Society of Anesthesiologists (ASA) physical status classification IV or higher, making the patient unfit for surgery.
- Preoperative serum albumin less than 2.5 g/dL, indicating severe malnutrition.
- Patients undergoing neoadjuvant chemotherapy or radiotherapy prior to surgery.
- Pregnancy or lactation.
- Contraindications to EUS (e.g., esophageal obstruction)
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Liver and GIT hospital / Minia university
Minya, Minya Governorate, 61519
About this study
Official title: Preoperative Endoscopic Ultrasound Elastography for Prediction of Intraoperative Pancreatic Texture and Postoperative Pancreatic Fistula After Pancreaticoduodenectomy: A Prospective Study
This prospective study evaluates whether preoperative endoscopic ultrasound elastography (EUS-E) can predict pancreatic texture during surgery and risk of postoperative pancreatic fistula (POPF) in 100 patients undergoing pancreaticoduodenectomy. EUS-E measures pancreatic stiffness preoperatively. Intraoperative texture ("soft" or "hard") is assessed by surgeons blinded to EUS-E results. POPF is graded using ISGPF criteria. Predictive accuracy of EUS-E will be analyzed statistically.
Read the detailed description
Pancreaticoduodenectomy is a complex surgery with significant morbidity, primarily due to postoperative pancreatic fistula (POPF). Soft pancreatic texture is a major risk factor for POPF. Endoscopic ultrasound elastography (EUS-E) is a promising tool for assessing tissue stiffness. This study will prospectively enroll patients undergoing PD. Preoperative EUS-E will be performed, and intraoperative pancreatic texture will be assessed by the surgeon. Postoperative outcomes, especially POPF, will be meticulously recorded. The study will analyze the diagnostic accuracy of EUS-E for pancreatic texture, its correlation with POPF severity,, as well as the impact on patient outcomes. Data will be collected from medical records, EUS reports, surgical notes, and pathology reports, with strict quality control and confidentiality measures. Statistical analysis will include Receiver Operating Characteristic (ROC) curve analysis for accuracy, and regression analyses to identify predictors and assess impact on outcomes.
In this study, blinding (masking) is implemented as follows:
- Surgeons are blinded to the results of the preoperative endoscopic ultrasound (EUS) elastography. They do not have access to the pancreatic stiffness measurements before or during surgery, ensuring their intraoperative assessment of pancreatic texture remains unbiased.
- Outcome assessors-those evaluating postoperative pancreatic fistula (POPF) and other clinical outcomes-are also blinded to both the preoperative elastography results and the intraoperative texture assessment. This reduces the risk of detection bias when determining study endpoints.
- Conditions
- Pancreatic Neoplasms, Pancreatic Fistula
- Being tested
- Preoperative Endoscopic Ultrasound Elastography (EUS Elastography)
- Keywords
- Pancreatic cancer, EUS, Whipple procedure, EUS-E, Pancreatic surgery, Pancreas, Elastography
- Medical subject headings
- Pancreatic Neoplasms, Pancreatic Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative Endoscopic Ultrasound Elastography (EUS Elastography)Procedure or surgery
All enrolled patients will undergo a preoperative EUS-E examination within one weeks prior to pancreaticoduodenectomy. The EUS-E will be performed by experienced endosonographers using a radial or linear array echoendoscope connected to a compatible ultrasound processor. Both qualitative (color mapping) and quantitative (strain ratio, strain histogram) data will be obtained. Multiple measurements of the strain ratio will be taken from a region of interest within the pancreatic parenchyma adjacent to the lesion. The mean strain ratio will be recorded for analysis. Standard EUS imaging will also be recorded.
Standard pancreaticoduodenectomy will be performed . Intraoperative pancreatic texture will be subjectively assessed by the surgeon and recorded. Postoperative monitoring for pancreatic fistula will follow established clinical guidelines.
| Study group | Role | What they receive |
|---|---|---|
| Preoperative Endoscopic Ultrasound Elastography (EUS Elastography) | Patients undergoing elective pancreaticoduodenectomy (PD) who will receive preoperative endoscopic ultrasound elastography (EUS elastography) evaluation. Receives: Procedure: Preoperative Endoscopic Ultrasound Elastography (EUS Elastography) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of preoperative EUS elastography in predicting intraoperative pancreatic texture (soft vs. hard).
Assessed by calculating sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and overall accuracy of EUS-E parameters (e.g., strain ratio) against the intraoperative tactile assessment of pancreatic texture.
Measured: Intraoperative at the time of pancreaticoduodenectomy (for tactile assessment) and pre-operative (for EUS-E).
Secondary outcomes (2)
Incidence of Postoperative Pancreatic Fistula (POPF)
Occurrence of POPF classified by the International Study Group on Pancreatic Fistula (ISGPF) grading system (Grades A, B, and C) within 30 days after pancreaticoduodenectomy.
Measured: Up to 30 days post-surgery.
Correlation between EUS Elastography Parameters and POPF Severity.
Relationship between quantitative EUS-E parameters and the incidence and severity of POPF.
Measured: Preoperative (EUS-E) and postoperative (POPF) evaluated within 30 days post-surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2025
- Study start1 Sep 2025
- Primary completion16 Aug 2026
- Study completion16 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic NeoplasmsStudies of the same condition, open and under way.
- More trials run by Minia UniversityThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Saleh Khairy Saleh MD, Minia University
- Investigators
- Saleh K Saleh, MD, Principal investigator, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07139236
- Sponsor's protocol ID
- 1378/12/2024
- Acronym
- EUS-E
- Status last verified
- Aug 2026
- First submitted
- 17 Aug 2025
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Endoscopic Ultrasound Elastography for Prediction of Intraoperative Pancreatic Texture and Postoperative Pancreatic Fistula After Pancreaticoduodenectomy: A Prospective Study
- ClinicalTrials.gov ID
- NCT07139236
- Acronym / sponsor ID
- EUS-E / 1378/12/2024
- Conditions
- Pancreatic Neoplasms, Pancreatic Fistula
- Keywords
- Pancreatic cancer, EUS, Whipple procedure, EUS-E, Pancreatic surgery, Pancreas, Elastography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 16 Aug 2026 (actual)
- Study completion
- 16 Aug 2026 (actual)
- First posted
- 24 Aug 2025 (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.
This prospective study evaluates whether preoperative endoscopic ultrasound elastography (EUS-E) can predict pancreatic texture during surgery and risk of postoperative pancreatic fistula (POPF) in 100 patients undergoing pancreaticoduodenectomy. EUS-E measures pancreatic stiffness preoperatively. Intraoperative texture ("soft" or "hard") is assessed by surgeons blinded to EUS-E results. POPF is graded using ISGPF criteria. Predictive accuracy of EUS-E will be analyzed statistically.
Detailed description
Pancreaticoduodenectomy is a complex surgery with significant morbidity, primarily due to postoperative pancreatic fistula (POPF). Soft pancreatic texture is a major risk factor for POPF. Endoscopic ultrasound elastography (EUS-E) is a promising tool for assessing tissue stiffness. This study will prospectively enroll patients undergoing PD. Preoperative EUS-E will be performed, and intraoperative pancreatic texture will be assessed by the surgeon. Postoperative outcomes, especially POPF, will be meticulously recorded. The study will analyze the diagnostic accuracy of EUS-E for pancreatic texture, its correlation with POPF severity,, as well as the impact on patient outcomes. Data will be collected from medical records, EUS reports, surgical notes, and pathology reports, with strict quality control and confidentiality measures. Statistical analysis will include Receiver Operating Characteristic (ROC) curve analysis for accuracy, and regression analyses to identify predictors and assess impact on outcomes.
In this study, blinding (masking) is implemented as follows:
- Surgeons are blinded to the results of the preoperative endoscopic ultrasound (EUS) elastography. They do not have access to the pancreatic stiffness measurements before or during surgery, ensuring their intraoperative assessment of pancreatic texture remains unbiased.
- Outcome assessors-those evaluating postoperative pancreatic fistula (POPF) and other clinical outcomes-are also blinded to both the preoperative elastography results and the intraoperative texture assessment. This reduces the risk of detection bias when determining study endpoints.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Preoperative Endoscopic Ultrasound Elastography (EUS Elastography) | – | Procedure: Preoperative Endoscopic Ultrasound Elastography (EUS Elastography)Patients undergoing elective pancreaticoduodenectomy (PD) who will receive preoperative endoscopic ultrasound elastography (EUS elastography) evaluation. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population includes adults aged 18 and older scheduled for elective pancreaticoduodenectomy (PD) for resectable pancreatic head or periampullary diseases, such as pancreatic cancer, periampullary cancer, distal bile duct cancer and duodenal cancer. Patients must be medically fit for major surgery, with adequate organ function and physiological reserve, based on clinical and anesthesiology assessments. Exclusions apply to those with distant metastases, locally advanced unresectable tumors, prior pancreatic surgery, or chronic pancreatitis to avoid confounding tissue assessment. Patients often present with symptoms like jaundice or abdominal discomfort and are managed in specialized pancreatic centers with multidisciplinary care. This cohort is appropriate for evaluating preoperative endoscopic ultrasound elastography as a tool to predict intraoperative pancreatic texture and postoperative pancreatic fistula risk.
Key inclusion criteria (9 listed)
- Adult patients aged 18 years or older.
- Patients scheduled for elective pancreaticoduodenectomy (PD) due to pancreatic head or periampullary disease, including but not limited to:
- Patients deemed suitable for PD by the multidisciplinary pancreatic surgery team based on preoperative imaging and clinical evaluation.
- Adequate organ function and physiological reserve to undergo major abdominal surgery, as determined by clinical assessment and anesthesiology evaluation.
Key exclusion criteria (8 listed)
- Evidence of distant metastases or locally advanced unresectable disease on preoperative imaging or clinical evaluation (e.g., liver metastases, peritoneal carcinomatosis, involvement of major vessels beyond resectability).
- Previous pancreatic surgery or total pancreatectomy.
- Chronic pancreatitis confirmed by clinical, radiological, or histological criteria that could confound pancreatic stiffness assessment.
- Severe comorbidities or American Society of Anesthesiologists (ASA) physical status classification IV or higher, making the patient unfit for surgery.
- Preoperative serum albumin less than 2.5 g/dL, indicating severe malnutrition.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Preoperative Endoscopic Ultrasound Elastography (EUS Elastography)All enrolled patients will undergo a preoperative EUS-E examination within one weeks prior to pancreaticoduodenectomy. The EUS-E will be performed by experienced endosonographers using a radial or linear array echoendoscope connected to a compatible ultrasound processor. Both qualitative (color mapping) and quantitative (strain ratio, strain histogram) data will be obtained. Multiple measurements of the strain ratio will be taken from a region of interest within the pancreatic parenchyma adjacent to the lesion. The mean strain ratio will be recorded for analysis. Standard EUS imaging will also be recorded. Standard pancreaticoduodenectomy will be performed . Intraoperative pancreatic texture will be subjectively assessed by the surgeon and recorded. Postoperative monitoring for pancreatic fistula will follow established clinical guidelines. | Procedure or surgery | Preoperative Endoscopic Ultrasound Elastography (EUS Elastography) |
Primary outcome
Accuracy of preoperative EUS elastography in predicting intraoperative pancreatic texture (soft vs. hard).
Time frame: Intraoperative at the time of pancreaticoduodenectomy (for tactile assessment) and pre-operative (for EUS-E).
Assessed by calculating sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and overall accuracy of EUS-E parameters (e.g., strain ratio) against the intraoperative tactile assessment of pancreatic texture.
2 secondary outcomes
Incidence of Postoperative Pancreatic Fistula (POPF)
Time frame: Up to 30 days post-surgery.
Correlation between EUS Elastography Parameters and POPF Severity.
Time frame: Preoperative (EUS-E) and postoperative (POPF) evaluated within 30 days post-surgery.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Saleh K Saleh, MD principal investigator
Minia University
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 Pancreatic Neoplasms and Pancreatic Fistula, run by Minia University at 1 site in Egypt.
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 9 inclusion and 8 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: finished, as of the sponsor's last update on 18 Aug 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 Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of preoperative EUS elastography in predicting intraoperative pancreatic texture (soft vs. hard). (time frame: Intraoperative at the time of pancreaticoduodenectomy (for tactile assessment) and pre-operative (for EUS-E).). 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 18 Aug 2026.