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Pancreatic Head CancerTMpENCT07232810

Prognostic Outcomes of Total Mesopancreas Excision for Pancreatic Head Cancer

A study testing Total Mesopancreas Excision (TMpE) in people with Pancreatic Head Cancer and Pancreatic Ductal Adenocarcinoma, run by Minia University at 1 site in Egypt.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Total Mesopancreas Excision (TMpE)
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 siteEgypt
Study dates
1 Dec 2025to 20 Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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).
Show all 9Show fewer
  • Pregnancy or lactation.
  • Patients who have received prior radiotherapy to the abdomen.
  • Patients unwilling or unable to provide informed consent.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Egypt1 site, 1 recruiting
  • Liver and GIT hospital , Minia University

    Minya, Minya Governorate, 61519

    Saleh K Saleh, MD, 01201765401 ext. +2, salehkhairy@mu.edu.eg

    Recruiting

Other trials in Egypt

About this study

Official title: Prognostic Outcomes of Total Mesopancreas Excision During Pancreaticoduodenectomy for Pancreatic Head Cancer

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.

Read the 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 determine disease-free survival (DFS).

Secondary Objectives:

  • To assess the impact of TMpE on overall survival (OS).
  • To evaluate R0 resection rates and surgical morbidity.
  • To identify predictors of recurrence and survival through preoperative,intraoperative, and postoperative data.

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.
Being tested
Total Mesopancreas Excision (TMpE)
Keywords
Total Mesopancreas Excision, TMpE, Pancreaticoduodenectomy, Pancreatic Cancer, DFS, R0 Resection
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Total Mesopancreas Excision (TMpE)Procedure or surgery

    Also called TMpE

    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.

Study groups in NCT07232810
Study groupRoleWhat they receive
Total Mesopancreas Excision (TMpE)ExperimentalPatients with resectable or borderline resectable pancreatic head cancer undergoing pancreaticoduodenectomy with curative intent.
Receives: Procedure: Total Mesopancreas Excision (TMpE)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Disease-Free Survival (DFS)

    Time from surgery to first evidence of local recurrence, distant metastases, or death from any cause, whichever occurs first.

    Measured: 24 months post-surgery

Secondary outcomes (7)
  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.

    Measured: 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.

    Measured: Within 30 days post-surgery (Pathology report)

  3. Completeness of Mesopancreas Excision

    Assessment through detailed pathological evaluation.

    Measured: Within 30 days post-surgery (Pathology report)

  4. Overall Survival (OS)

    Time from surgery to death from any cause.

    Measured: Up to 24 months post-surgery

  5. Prognostic Factors

    Identification of factors (preoperative, intraoperative,and pathological) associated with DFS and OS.

    Measured: Up to 24 months post-surgery

  6. Recurrence-Free Survival (RFS)

    Time from the date of surgery to the date of first recurrence (local, regional, or distant).Calculated in months from the date of surgery. Recurrence will be confirmed by imaging (CT/MRI), biopsy, or clinical assessment. Patients without recurrence will be censored at the last follow-up date.

    Measured: Up to 2 years post-surgery

  7. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Nov 2025
  2. Study start1 Dec 2025
  3. Primary completion1 Dec 2027 (estimated)
  4. Study completion20 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
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.
Masking
None (open label)
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07232810
Sponsor's protocol ID
1702/09/2025
Acronym
TMpE
Status last verified
Nov 2025
First submitted
13 Nov 2025
Last updated
2 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 33775563
  • 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.

    PubMed 29151943

Questions about this trial

What is this clinical trial studying?

A study testing Total Mesopancreas Excision (TMpE) in people with Pancreatic Head Cancer and Pancreatic Ductal Adenocarcinoma, run by Minia University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Saleh K Saleh, MD (01201765401 ext. +2, salehkhairy@mu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease-Free Survival (DFS) (time frame: 24 months post-surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07232810, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2025.

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