AzTrials
AzTrials

Pancreatic Ductal AdenocarcinomaTMpENCT07148830

Mesopancreatic Excision for Pancreatic Duct Adenocarcinoma.

A study testing Total Mesopancreas Excision (TMpE) (as part of Pancreaticoduodenectomy) in people with Pancreatic Ductal Adenocarcinoma and Pancreatic Cancer, 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
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Total Mesopancreas Excision (TMpE) (as part of Pancreaticoduodenectomy)
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteEgypt
Study dates
1 Apr 2024to 1 May 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 75 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

  • 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).
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

    Rabeh K Saleh, MD

    Recruiting

Other trials in Egypt

About this study

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

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.

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 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.
Being tested
Total Mesopancreas Excision (TMpE) (as part of Pancreaticoduodenectomy)
Keywords
Mesopancreatic excision, TMpE
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) (as part of Pancreaticoduodenectomy)Procedure or surgery

    • 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 NCT07148830
Study groupRoleWhat they receive
Total Mesopancreas Excision (TMpE) (as part of Pancreaticoduodenectomy)ExperimentalEn 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.
Receives: Procedure: Total Mesopancreas Excision (TMpE) (as part of Pancreaticoduodenectomy)

What is being measured

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

  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).

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

Secondary outcomes (5)
  1. Disease-Free Survival (DFS)

    Time from the date of surgery to the date of first recurrence (local, regional, or distant) or death from any cause, whichever occurs first.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.

  2. 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.

  3. Patterns of Recurrence

    Location and timing of tumor recurrence (local, regional,distant). Recurrence will be categorized as local (surgical bed, regional lymph nodes), regional (e.g., peritoneal carcinomatosis), or distant (e.g., liver, lung). Time to each type of recurrence will be recorded.

    Measured: Up to 2 years post-surgery.

  4. 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 .

  5. Perioperative Morbidity and Mortality

    Incidence and severity of surgical complications and death within 30 or 90 days post-surgery.

    Complications include pancreatic fistula, delayed gastric emptying, post- pancreatectomy hemorrhage, wound infection, and other surgical site infections will be collected. Mortality will be recorded as 30-day and 90-day mortality rates.

    Measured: Within 90 days post-surgery.

Timeline

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

  1. First posted29 Aug 2025
  2. Study start1 Apr 2024
  3. Primary completion1 Apr 2027 (estimated)
  4. Study completion1 May 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 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.
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07148830
Sponsor's protocol ID
1118/02/2024
Acronym
TMpE
Status last verified
Sep 2026
First submitted
17 Aug 2025
Last updated
11 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
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) (as part of Pancreaticoduodenectomy) in people with Pancreatic Ductal Adenocarcinoma and Pancreatic Cancer, 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 11 Sep 2026. 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?

Local Disease Control (time frame: Up to 2 years post-surgery (assessed at 3, 6, 12, 18 and 24 months).). 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 NCT07148830, 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 11 Sep 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in