Mesopancreatic Excision for Pancreatic Duct Adenocarcinoma.
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorMinia University
About this trial
Pancreatic ductal adenocarcinoma (PDAC) is an aggressive cancer with high rates of local recurrence and distant metastasis.
Recent evidence suggests that mesopancreatic excision (TMpE) may improve R0 resection rates, reduce local recurrence, and enhance overall survival compared to standard pancreatoduodenectomy. However, most existing studies are retrospective with heterogeneous patient populations and surgical techniques.
This prospective study aims to evaluate the impact of mesopancreatic excision, a surgical technique involving the meticulous removal of retroperitoneal tissue surrounding major peripancreatic vessels, on local disease control and overall survival in patients undergoing pancreaticoduodenectomy for resectable PDAC. The study will also assess R0 resection rates, disease-free survival, recurrence patterns and perioperative outcomes.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 years.
Patients scheduled to undergo pancreaticoduodenectomy with planned mesopancreatic excision.
Histologically confirmed PDAC of the pancreatic head (via endoscopic ultrasound-guided biopsy).
Resectable disease per National Comprehensive Cancer Network(NCCN) guidelines (no distant metastases, no arterial involvement >180°, venous involvement reconstructable).
Disqualifiers
Borderline resectable or unresectable PDAC.
Distant metastases.
Periampullary tumors other than pancreatic adenocarcinoma
Prior neoadjuvant chemotherapy or radiotherapy (to isolate TMpE effect; may be amended for subgroups).
Trial design
Design model
Single group
Treatments tested in this trial
Total Mesopancreas Excision (TMpE) (as part of Pancreaticoduodenectomy)
Procedure/Surgery* All patients undergo pancreaticoduodenectomy with total mesopancreatic excision (TMpE) and Adjuvant chemotherapy. * Meticulous dissection and en bloc removal of the fatty tissue and perineural lymphatic layer located between the head of the pancreas and the superior mesenteric vessels (superior mesenteric artery and portal vein) and the celiac axis, performed during pancreaticoduodenectomy.
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: Total Mesopancreas Excision (TMpE) (as part of Pancreaticoduodenectomy)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Local Disease Control
Defined as tumor recurrence in the pancreatic bed, retroperitoneum, or regional nodes (via CT/MRI/ positron emission tomography (PET)-CT). Assessed by RECIST 1.1 criteria. Time-to-recurrence was calculated from surgery date to detection date (Kaplan-Meier estimation).
Time frame
Up to 2 years post-surgery (assessed at 3, 6, 12, 18 and 24 months).Secondary outcomes
1
Disease-Free Survival (DFS)
Time from the date of surgery to the date of first recurrence (local, regional, or distant) or death from any cause, whichever occurs first.Calculated in months from the date of surgery. Recurrence will be confirmed by imaging (CT/MRI), biopsy, or clinical assessment. Patients without recurrence will be censored at the last follow-up date.
Time frame
Up to 2 years post-surgery.2
Recurrence-Free Survival (RFS)
Time from the date of surgery to the date of first recurrence (local, regional, or distant).Calculated in months from the date of surgery. Recurrence will be confirmed by imaging (CT/MRI), biopsy, or clinical assessment. Patients without recurrence will be censored at the last follow-up date.
Time frame
Up to 2 years post-surgery.3
Patterns of Recurrence
Location and timing of tumor recurrence (local, regional,distant). Recurrence will be categorized as local (surgical bed, regional lymph nodes), regional (e.g., peritoneal carcinomatosis), or distant (e.g., liver, lung). Time to each type of recurrence will be recorded.
Time frame
Up to 2 years post-surgery.4
R0 Resection Rate
Complete microscopic removal of the tumor with all surgical margins (including mesopancreatic margin) free of tumor cells. Assessed according to standardized protocols (e.g., College of American Pathologists guidelines). The status of all margins (proximal, distal, circumferential, and mesopancreatic) will be recorded.
Time frame
Within 30 days post-surgery .Sponsors and contacts
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Source ClinicalTrials.gov