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.
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
- Conditions the study is for
- Pancreatic Head Cancer, Pancreatic Ductal Adenocarcinoma
- 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
- Recruiting
Liver and GIT hospital , Minia University
Minya, Minya Governorate, 61519
Saleh K Saleh, MD, 01201765401 ext. +2, salehkhairy@mu.edu.eg
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 group | Role | What they receive |
|---|---|---|
| Total Mesopancreas Excision (TMpE) | Experimental | Patients 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.
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)
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)
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)
Completeness of Mesopancreas Excision
Assessment through detailed pathological evaluation.
Measured: Within 30 days post-surgery (Pathology report)
Overall Survival (OS)
Time from surgery to death from any cause.
Measured: Up to 24 months post-surgery
Prognostic Factors
Identification of factors (preoperative, intraoperative,and pathological) associated with DFS and OS.
Measured: Up to 24 months post-surgery
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
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.
- First posted18 Nov 2025
- Study start1 Dec 2025
- Primary completion1 Dec 2027 (estimated)
- Study completion20 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pancreatic Head CancerStudies of the same condition, open and under way.
- More trials run by Minia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Saleh Khairy Saleh MD, Minia University
- Investigators
- Saleh K Saleh, MD, Principal investigator, Minia University
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 33775563Xu 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
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Outcomes of Total Mesopancreas Excision During Pancreaticoduodenectomy for Pancreatic Head Cancer
- ClinicalTrials.gov ID
- NCT07232810
- Acronym / sponsor ID
- TMpE / 1702/09/2025
- Keywords
- Total Mesopancreas Excision, TMpE, Pancreaticoduodenectomy, Pancreatic Cancer, DFS, R0 Resection
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 20 Dec 2027 (estimated)
- First posted
- 18 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Total Mesopancreas Excision (TMpE) | Experimental | Procedure: Total Mesopancreas Excision (TMpE)Patients with resectable or borderline resectable pancreatic head cancer undergoing pancreaticoduodenectomy with curative intent. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Total Mesopancreas Excision (TMpE)Also: TMpEAll 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. | Procedure or surgery | Total Mesopancreas Excision (TMpE) |
Primary outcome
Disease-Free Survival (DFS)
Time frame: 24 months post-surgery
Time from surgery to first evidence of local recurrence, distant metastases, or death from any cause, whichever occurs first.
7 secondary outcomes
R0 Resection Rate
Time frame: Within 30 days post-surgery (Pathology report)
Lymph Node Yield and Ratio
Time frame: Within 30 days post-surgery (Pathology report)
Completeness of Mesopancreas Excision
Time frame: Within 30 days post-surgery (Pathology report)
Overall Survival (OS)
Time frame: Up to 24 months post-surgery
Prognostic Factors
Time frame: Up to 24 months post-surgery
Recurrence-Free Survival (RFS)
Time frame: Up to 2 years post-surgery
Local Disease Control
Time frame: Up to 2 years post-surgery (assessed at 3, 6, 12, 18 and 24 months).]
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
- Background: PubMed 33775563Safi 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.
- Background: PubMed 29151943Xu 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Saleh K Saleh, MD principal investigator
Minia University
1 site in 1 country: see every site and its status.
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.