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New ultrasound test may predict dangerous pancreatic leaks after surgery

NCT ID NCT07139236

Knowledge-focused Sponsor: Minia University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Aug 19, 2026 · Updated 3 times

Summary

This study is testing whether a special type of ultrasound, called endoscopic ultrasound elastography, can predict the texture of the pancreas and the risk of a pancreatic fistula after a major surgery called pancreaticoduodenectomy. The study will enroll 100 adults scheduled for this surgery. The goal is to see if this non-invasive test can help doctors identify high-risk patients before the operation, potentially leading to better surgical planning and fewer complications.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could help surgeons better predict which patients are at high risk for pancreatic fistula after surgery, potentially reducing complications.
What could go wrong
This is a small, early-stage study (100 patients) focused on prediction, not treatment. The technique may not be accurate enough to change clinical practice, and results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

100 people

The number who actually took part.

Started

Sep 2025

Finished

Aug 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 * 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. Exclusion Criteria: * 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)

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Conditions

The condition(s) this trial relates to.

bile duct cancer carcinoma of duodenum malignant pancreatic neoplasm Pancreatic Fistula pancreatic neoplasm periampullary adenocarcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Pancreatic fistula Pancreatic neoplasms

Contacts and locations

Locations

  • Liver and GIT hospital / Minia university

    Minya, Minya Governorate, 61519, Egypt

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