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.
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
- Conditions the study is for
- Pancreatic Ductal Adenocarcinoma, Pancreatic Cancer
- 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
- 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
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 group | Role | What they receive |
|---|---|---|
| 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. 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.
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)
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.
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.
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.
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 .
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.
- First posted29 Aug 2025
- Study start1 Apr 2024
- Primary completion1 Apr 2027 (estimated)
- Study completion1 May 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 Ductal AdenocarcinomaStudies 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 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)
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
- 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 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 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Mesopancreatic Excision for Pancreatic Duct Adenocarcinoma on Local Disease Control and Survival.
- ClinicalTrials.gov ID
- NCT07148830
- Acronym / sponsor ID
- TMpE / 1118/02/2024
- Keywords
- Mesopancreatic excision, TMpE
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 29 Aug 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) 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.
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.
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 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.
| Arm | Type | Receives |
|---|---|---|
| Total Mesopancreas Excision (TMpE) (as part of Pancreaticoduodenectomy) | Experimental | Procedure: Total Mesopancreas Excision (TMpE) (as part of Pancreaticoduodenectomy)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. |
Who may qualify
- Ages
- 18 to 75 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)
- 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.
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) (as part of Pancreaticoduodenectomy)* 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. | Procedure or surgery | Total Mesopancreas Excision (TMpE) (as part of Pancreaticoduodenectomy) |
Primary outcome
Local Disease Control
Time frame: Up to 2 years post-surgery (assessed at 3, 6, 12, 18 and 24 months).
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).
5 secondary outcomes
Disease-Free Survival (DFS)
Time frame: Up to 2 years post-surgery.
Recurrence-Free Survival (RFS)
Time frame: Up to 2 years post-surgery.
Patterns of Recurrence
Time frame: Up to 2 years post-surgery.
R0 Resection Rate
Time frame: Within 30 days post-surgery .
Perioperative Morbidity and Mortality
Time frame: Within 90 days post-surgery.
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 11 Sep 2026.
- 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.
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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) (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.