Prognostic Outcomes of Total Mesopancreas Excision for Pancreatic Head Cancer

NCT07232810 | Recruiting DMC

• 1 other identifier: 1702/09/2025
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pancreatic Head Cancer; Pancreatic Ductal Adenocarcinoma

Keywords

Total Mesopancreas Excision; TMpE; Pancreaticoduodenectomy; Pancreatic Cancer; DFS; R0 Resection

Outcome Measures

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.

  24 months post-surgery

Secondary Outcomes (7)

• R0 Resection Rate

  Within 30 days post-surgery (Pathology report)

• Lymph Node Yield and Ratio

  Within 30 days post-surgery (Pathology report)

• Completeness of Mesopancreas Excision

  Within 30 days post-surgery (Pathology report)

• Overall Survival (OS)

  Up to 24 months post-surgery

• Prognostic Factors

  Up to 24 months post-surgery

Study Arms (1)

Total Mesopancreas Excision (TMpE)

EXPERIMENTAL

Patients with resectable or borderline resectable pancreatic head cancer undergoing pancreaticoduodenectomy with curative intent.

Procedure: Total Mesopancreas Excision (TMpE)

Interventions

Total Mesopancreas Excision (TMpE) 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.

Also known as: TMpE

Total Mesopancreas Excision (TMpE)

Eligibility Criteria

• Age: 18 Years - 80 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:

• Irresectable 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 Total Mesopancreas Excision (TMpE) for patients with pancreatic ductal adenocarcinoma (PDAC) undergoing pancreaticoduodenectomy. 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: November 13, 2025
• First Posted: November 18, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 20, 2027
• Last Updated: December 2, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)