Actively Recruiting
Preoperative Endoscopic Ultrasound Elastography for Prediction of Pancreatic Texture and Postoperative Pancreatic Fistula After Pancreaticoduodenectomy
Led by Minia University · Updated on 2025-09-03
100
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of preoperative endoscopic ultrasound elastography (EUS-E) to predict the texture of the pancreas during surgery and the risk of postoperative pancreatic fistula (POPF) in patients undergoing pancreaticoduodenectomy (PD). This study focuses on patients with pancreatic or periampullary diseases, including pancreatic cancer and other related cancers. The aim is to assess whether EUS-E, which measures pancreatic stiffness before surgery, can accurately forecast the pancreas's softness or hardness and corresponding surgical outcomes. All participants will receive a preoperative EUS-E exam performed by experienced specialists within one week before their PD surgery. Surgeons will then assess the pancreatic texture during surgery without knowing the EUS-E results to keep evaluations unbiased. The study will follow standard surgical procedures and monitor patients closely for complications such as POPF up to 30 days after surgery. During the study, researchers will collect data from medical records, EUS reports, surgical notes, and pathology reports while maintaining strict confidentiality. They will analyze the accuracy of EUS-E in predicting pancreatic texture and its relationship with POPF severity using statistical methods. Participants will be monitored throughout the surgery and recovery period to evaluate these outcomes, with the total participation lasting from preoperative assessment through at least 30 days post-surgery.
CONDITIONS
Brief Title
Preoperative EUS Elastography for Pancreatic Texture and POPF Prediction After PD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients aged 18 years or older
- Scheduled for elective pancreaticoduodenectomy due to pancreatic head or periampullary disease including pancreatic cancer, periampullary cancer, bile duct cancer, or duodenal cancer
- Deemed suitable for pancreaticoduodenectomy by the multidisciplinary surgery team
- Adequate organ function and physiological reserve to undergo major abdominal surgery
- Ability to provide written informed consent and comply with study procedures
You will not qualify if you...
- Distant metastases or locally advanced unresectable disease on preoperative imaging or clinical evaluation
- Previous pancreatic surgery or total pancreatectomy
- Chronic pancreatitis confirmed by clinical, radiological, or histological criteria
- Severe comorbidities or ASA physical status classification IV or higher
- Preoperative serum albumin less than 2.5 g/dL indicating severe malnutrition
- Undergoing neoadjuvant chemotherapy or radiotherapy prior to surgery
- Pregnancy or lactation
- Contraindications to endoscopic ultrasound such as esophageal obstruction
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Within 1 week prior to surgery
Participants undergo a preoperative endoscopic ultrasound elastography (EUS-E) examination to assess pancreatic tissue stiffness before surgery.
1 visit (in-person)
Duration - Hospital stay for surgery and immediate recovery
Participants undergo pancreaticoduodenectomy (PD) surgery where intraoperative pancreatic texture is assessed by the surgeon. Postoperative monitoring for pancreatic fistula is conducted following clinical guidelines.
1 surgical hospitalization
Duration - Up to 30 days post-surgery
Participants are monitored for postoperative pancreatic fistula (POPF) and other outcomes for up to 30 days after surgery.
Approximately 2 to 3 follow-up visits
Trial Site Locations
Total: 1 location
1
Liver and GIT hospital / Minia university
Minya, Minya Governorate, Egypt, 61519
Actively Recruiting
Research Team
S
Saleh K Saleh, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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