Prognostic Outcomes of Total Mesopancreas Excision for Pancreatic Head Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorMinia University
About this trial
Pancreatic ductal adenocarcinoma (PDAC) has poor prognosis due to high recurrence rates after standard pancreaticoduodenectomy (PD). The concept of Total Mesopancreas Excision (TMpE), analogous to total mesorectal excision, aims to improve oncological outcomes by achieving higher R0 resection rates through the comprehensive removal of retroperitoneal connective tissue surrounding major peripancreatic vessels. This single arm prospective study will evaluate the prognostic outcomes, primarily Disease- Free Survival (DFS) at 24 months, of a standardized TMpE technique performed during pancreaticoduodenectomy for resectable pancreatic head cancer. Secondary objectives include assessing Overall Survival (OS), R0 resection rates, recurrence patterns, and perioperative outcomes in 90 consecutive patients.
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
Irresectable 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)
Procedure/SurgeryAll 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
90 Participants
are divided into 1 treatment groupGroup A: Total Mesopancreas Excision (TMpE)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Disease-Free Survival (DFS)
Time from surgery to first evidence of local recurrence, distant metastases, or death from any cause, whichever occurs first.
Time frame
24 months post-surgerySecondary outcomes
1
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 (Pathology report)2
Lymph Node Yield and Ratio
To quantify the total number of lymph nodes harvested and the ratio of positive to total lymph nodes.
Time frame
Within 30 days post-surgery (Pathology report)3
Completeness of Mesopancreas Excision
Assessment through detailed pathological evaluation.
Time frame
Within 30 days post-surgery (Pathology report)4
Overall Survival (OS)
Time from surgery to death from any cause.
Time frame
Up to 24 months post-surgerySponsors and contacts
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Source ClinicalTrials.gov