Mesopancreatic Excision for Pancreatic Duct Adenocarcinoma.

NCT07148830 | Recruiting DMC

• 1 other identifier: 1118/02/2024
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Ductal Adenocarcinoma; Pancreatic Cancer

Keywords

Mesopancreatic excision; TMpE

Outcome Measures

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).

  Up to 2 years post-surgery (assessed at 3, 6, 12, 18 and 24 months).

Secondary Outcomes (5)

• Disease-Free Survival (DFS)

  Up to 2 years post-surgery.

• Recurrence-Free Survival (RFS)

  Up to 2 years post-surgery.

• Patterns of Recurrence

  Up to 2 years post-surgery.

• R0 Resection Rate

  Within 30 days post-surgery .

• Perioperative Morbidity and Mortality

  Within 90 days post-surgery.

Study Arms (1)

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

EXPERIMENTAL

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.

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

Interventions

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

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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Minia University: lead

Study Sites (1)

Liver and GIT hospital , Minia University

Minya, Minya Governorate, 61519, Egypt

RECRUITING

Related Publications (2)

• 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.

  PMID: 33775563 BACKGROUND

• 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.

  PMID: 29151943 BACKGROUND

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Saleh K Saleh, MD

  Minia University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Saleh K Saleh, MD

CONTACT

01201765401; salehkhairy@mu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Model Details: This is a prospective, single-arm, interventional clinical trial designed to evaluate the effect of standardized mesopancreatic excision (MPE) for patients with pancreatic ductal adenocarcinoma (PDAC) undergoing pancreatoduodenectomy. The intervention involves surgical removal of the pancreatic head with en bloc excision of the mesopancreatic lamina and surrounding peri-pancreatic fat tissue including tissue adjacent to major vessels to improve circumferential resection margin (CRM) negativity.

Study Record Dates

• First Submitted: August 17, 2025
• First Posted: August 29, 2025
• Study Start: April 1, 2024
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: August 29, 2025

Record last verified: 2025-08

Locations

EG (1)