NCT07148830

Mesopancreatic Excision for Pancreatic Duct Adenocarcinoma.

Effect of Mesopancreatic Excision for Pancreatic Duct Adenocarcinoma on Local Disease Control and Survival.

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Minia University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Pancreatic duct adenocarcinoma (PDAC) is one of the most aggressive malignancies, with a 5-year overall survival rate of approximately 20-25% even after curative resection. Standard pancreaticoduodenectomy (PD, or Whipple procedure) often results in high rates of local recurrence (up to 40-50%) due to incomplete clearance of peripancreatic tissues, leading to R1 resections in 15-35% of cases. The concept of the "mesopancreas" was introduced by Gockel et al. in 2007 as an anatomical entity analogous to the mesorectum in rectal cancer surgery. Excision of the mesopancreas aims to achieve total en bloc removal of retroperitoneal tissues harboring lymphatic, neural, and vascular pathways for tumor spread, potentially improving R0 resection rates (to 80-90%), reducing local recurrence (to 15-20%), and enhancing survival. Existing retrospective and meta-analyses suggest that total mesopancreatic excision (TMpE) increases R0 rates and reduces locoregional recurrence while maintaining acceptable safety. However, prospective data are limited, and no large randomized trials exist. This study prospectively evaluates TMpE in resectable PDAC to assess its impact on local control and survival . Objectives Primary Objectives: • To evaluate the effect of TMpE on local disease control (locoregional recurrence rate). Secondary Objectives: * To assess the impact of TMpE on overall survival (OS). * To determine disease-free survival (DFS). * To evaluate R0 resection rates and surgical morbidity. * To identify predictors of recurrence and survival through preoperative, intraoperative, and postoperative data. Follow-up Schedule: Postoperative visits at 1, 3, 6, 12, 18, and 24 months; imaging (CT/MRI) every 3-6 months for 2 years. DEFINITION OF MESOPANCREAS The mesopancreas is defined as the retropancreatic tissue located posterior to the pancreatic head, encompassing: * Anatomical boundaries: Inverted triangle with apex at the origins of celiac trunk (CT), hepatic artery, and superior mesenteric artery (SMA), and base at the posterior aspect of superior mesenteric vein(SMV) and portal vein(PV) * Tissue components: Adipose tissue, peripheral nerves and plexuses, vascular structures, lymphogenic structures, and locoregional lymph nodes * Alternative nomenclature: "Pancreatic head plexus", "retroportal lamina", "mesopancreatoduodenum" * Surgical margins: Includes retroperitoneal, uncinate, posterior, and portal vein groove margins This structure is the primary site for positive resection margins (R1) in PDAC and is implicated in locoregional spread. * Level of Dissection: The extent of mesopancreatic dissection can vary: * Level 1: Dissection close to the pancreatic capsule. * Level 2: Dissection along the superior mesenteric vein and portal vein. * Level 3 (Total Mesopancreas Excision): it involves dissecting along the entire length of the SMA and celiac axis, removing all lymphatic and neural tissue surrounding these vessels. * Mesopancreatic Excision (TMpE, Level 3): * After pancreatic neck transection, focus on posterior dissection. * Identify the mesopancreas as the retroperitoneal fibro-fatty tissue posterior to the pancreatic head. * Dissect along the right aspect of the SMA, exposing its origin from the aorta. * Extend dissection to the celiac trunk and right celiac ganglion, resecting nerve plexuses (e.g., plexus pancreaticus I and II). * Clear the aorto-caval groove laterally, including para-aortic lymph nodes (stations 16a2/b1 if involved). * En bloc removal of the mesopancreas: triangular resection bounded by portal vein /SMV (medial), SMA/celiac axis (posterior), and pancreatic head (anterior). Includes all lymphatic, neural, and fatty tissues up to the anterior aortic surface. * Ensure circumferential margin clearance: frozen section if needed for pancreatic neck, bile duct, and posterior margins. * Vascular skeletonization: clear adventitia of SMA and celiac trunk.

Conditions

• Pancreatic Ductal Adenocarcinoma
• Pancreatic Cancer

Interventions

Type	Name	Description
PROCEDURE	Total Mesopancreas Excision (TMpE) (as part of Pancreaticoduodenectomy)	* 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.

Timeline

• Start date: 2024-04-01
• Primary completion: 2027-04-01
• Completion: 2027-05-01
• First posted: 2025-08-29
• Last updated: 2025-08-29

Locations

1 site across 1 country: Egypt