Mesopancreatic Excision for Pancreatic Duct Adenocarcinoma.

NCT ID: NCT07148830

Last Updated: 2025-08-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-01
• Study Completion Date: 2027-05-01

Brief 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

Keywords

Mesopancreatic excision; TMpE

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Total Mesopancreas Excision (TMpE) (as part of Pancreaticoduodenectomy)

En bloc removal of the fatty tissue and perineural lymphatic layer located between the head of the pancreas and the superior mesenteric vessels and the celiac axis, performed during pancreaticoduodenectomy.

Group Type: EXPERIMENTAL

Total Mesopancreas Excision (TMpE) (as part of Pancreaticoduodenectomy)

Intervention Type: PROCEDURE

• 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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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).
• Eastern Cooperative Oncology Group(ECOG) performance status 0-2.
• Adequate organ function (e.g., bilirubin <1.5x upper limit of normal(ULN), creatinine clearance >50 mL/min).
• Informed consent.

Exclusion Criteria

• 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).
• Active second malignancy.
• Severe comorbidities precluding surgery (e.g., uncontrolled cardiac disease).
• Pregnancy or lactation.
• Patients who have received prior radiotherapy to the abdomen.
• Patients unwilling or unable to provide informed consent.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Minia University

OTHER

Sponsor Role: lead

Responsible Party

Saleh Khairy Saleh MD

Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Saleh K Saleh, MD

Role: PRINCIPAL_INVESTIGATOR

Minia University

Locations

Liver and GIT hospital , Minia University

Minya, Minya Governorate, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Saleh K Saleh, MD

Role: CONTACT

Phone: 01201765401

Email: salehkhairy@mu.edu.eg

Facility Contacts

Saleh K Saleh, MD

Role: primary

References

Safi SA, Haeberle L, Fluegen G, Lehwald-Tywuschik N, Krieg A, Keitel V, Luedde T, Esposito I, Rehders A, Knoefel WT. Mesopancreatic excision for pancreatic ductal adenocarcinoma improves local disease control and survival. Pancreatology. 2021 Jun;21(4):787-795. doi: 10.1016/j.pan.2021.02.024. Epub 2021 Mar 17.

Reference Type: BACKGROUND

PMID: 33775563 (View on PubMed)

Xu J, Tian X, Chen Y, Ma Y, Liu C, Tian L, Wang J, Dong J, Cui D, Wang Y, Zhang W, Yang Y. Total mesopancreas excision for the treatment of pancreatic head cancer. J Cancer. 2017 Sep 30;8(17):3575-3584. doi: 10.7150/jca.21341. eCollection 2017.

Reference Type: BACKGROUND

PMID: 29151943 (View on PubMed)

Other Identifiers

1118/02/2024

Identifier Type: -

Identifier Source: org_study_id