Pancreatic Ductal AdenocarcinomaNCT07328607
Outcomes After Laparoscopic Versus Open Pancreaticoduodenectomy
A study testing Open Pancreaticoduodenectomy and Laparoscopic Pancreaticoduodenectomy in people with Pancreatic Ductal Adenocarcinoma and Ampullary Carcinoma, run by Minia University at 1 site in Egypt.
Trial summary
This is a monocentric, prospective, randomized controlled trial comparing the safety and efficacy of laparoscopic pancreaticoduodenectomy (LPD) versus open pancreaticoduodenectomy (OPD). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pancreatic Ductal Adenocarcinoma, Ampullary Carcinoma, Distal Cholangiocarcinoma
- What is being tested?
- Open Pancreaticoduodenectomy and Laparoscopic Pancreaticoduodenectomy
- 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
- 17 Jan 2026to 15 Apr 2028
- 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.
- Histologically confirmed or clinically suspected lesions of: Pancreatic head adenocarcinoma, Ampullary carcinoma, Distal cholangiocarcinoma, Duodenal adenocarcinoma, Pancreatic neuroendocrine tumors, or Intraductal Papillary Mucinous Neoplasm(IPMN) .
- Resectable disease based on preoperative imaging.
- Eastern Cooperative Oncology Group(ECOG) performance status 0-2.
- American Society of Anesthesiologists(ASA )classification I-III.
- Patients able to provide informed consent.
Who cannot join
- Emergency surgery.
- Previous pancreatic surgery.
- Concurrent major abdominal procedures .
- ASA classification IV or higher.
- Metastatic disease identified preoperatively.
- Locally advanced unresectable disease.
Show all 10Show fewer
- Active infection or sepsis at time of surgery.
- Severe cardiopulmonary comorbidities precluding major surgery.
- Pregnancy.
- Procedures requiring Total Pancreatectomy, Distal Pancreatectomy, or Enucleation .
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, salehkhairy@mu.edu.eg
About this study
Official title: Open Versus Laparoscopic Pancreaticoduodenectomy: A Randomized Controlled Trial
This is a monocentric, prospective, randomized controlled trial comparing the safety and efficacy of laparoscopic pancreaticoduodenectomy (LPD) versus open pancreaticoduodenectomy (OPD). The study aims to determine the morbimortality of the laparoscopic approach compared to the gold standard open approach in adult patients with pancreatic or periampullary lesions.
Read the detailed description
This is a monocentric, prospective, randomized controlled trial comparing the safety and efficacy of laparoscopic pancreaticoduodenectomy (LPD) versus open pancreaticoduodenectomy (OPD). The study aims to determine the morbimortality of the laparoscopic approach compared to the gold standard open approach in adult patients with pancreatic or periampullary lesions.
This study will randomize 90 eligible patients to receive either LPD or OPD. The primary objective is to compare overall morbidity using the Clavien-Dindo Classification at 90 days postoperative. Secondary objectives include assessment of oncologic outcomes (lymph node harvest, margin status), perioperative metrics (operative time, blood loss), and postoperative recovery (length of stay, readmissions). The study utilizes a prospectively maintained database and adheres to CONSORT guidelines.
- Conditions
- Pancreatic Ductal Adenocarcinoma, Ampullary Carcinoma, Distal Cholangiocarcinoma, Duodenal Adenocarcinoma, Pancreatic Neuroendocrine Tumor
- Being tested
- Open Pancreaticoduodenectomy, Laparoscopic Pancreaticoduodenectomy
- Medical subject headings
- Adenoma, Islet Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open PancreaticoduodenectomyProcedure or surgery
Open Pancreaticoduodenectomy with lymphadenectomy and reconstruction via open technique.
Laparoscopic PancreaticoduodenectomyProcedure or surgery
Minimally invasive Whipple procedure using 6 trocars, with specimen extraction via Pfannenstiel incision.
| Study group | Role | What they receive |
|---|---|---|
| Open Pancreaticoduodenectomy (OPD) | Active comparator | Patients randomized to receive standard open pancreaticoduodenectomy through a bilateral subcostal incision. Receives: Procedure: Open Pancreaticoduodenectomy |
| Laparoscopic Pancreaticoduodenectomy (LPD) | Experimental | Patients randomized to receive total laparoscopic pancreaticoduodenectomy using a standardized six-port technique. Receives: Procedure: Laparoscopic Pancreaticoduodenectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Morbidity (Clavien-Dindo Classification)
Assessment of all surgical complications graded by severity using the Clavien-Dindo Classification (Grades I-V). Major complications are defined as Grade III or higher.
Measured: 90 days postoperative.
Secondary outcomes (5)
Number of Lymph Nodes Retrieved
Total count of lymph nodes harvested and examined by pathology.
Measured: 14 days postoperative.
Resection Margin Status (R0/R1/R2)
Pathological assessment of margins (Pancreatic neck, bile duct, retroperitoneal, etc.) classified as R0 (>1mm), R1 (≤1mm), or R2 (macroscopic).
Measured: 14 days postoperative.
Operative Time
Time measured from skin incision to skin closure.
Measured: Intraoperative
Estimated Blood Loss
Total blood loss recorded by the anesthesiology team.
Measured: Intraoperative
Length of Hospital Stay
Total number of days from admission to discharge.
Measured: Up to 90 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2026
- Study start17 Jan 2026
- Primary completion15 Jan 2028 (estimated)
- Study completion15 Apr 2028 (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
- Randomised
- Intervention model
- Parallel groups
- 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
- NCT07328607
- Sponsor's protocol ID
- 1838/12/2025
- Status last verified
- Jan 2026
- First submitted
- 27 Dec 2025
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Adam MA, Choudhury K, Dinan MA, Reed SD, Scheri RP, Blazer DG 3rd, Roman SA, Sosa JA. Minimally Invasive Versus Open Pancreaticoduodenectomy for Cancer: Practice Patterns and Short-term Outcomes Among 7061 Patients. Ann Surg. 2015 Aug;262(2):372-7. doi: 10.1097/SLA.0000000000001055.
PubMed 26158612Poves I, Burdio F, Morato O, Iglesias M, Radosevic A, Ilzarbe L, Visa L, Grande L. Comparison of Perioperative Outcomes Between Laparoscopic and Open Approach for Pancreatoduodenectomy: The PADULAP Randomized Controlled Trial. Ann Surg. 2018 Nov;268(5):731-739. doi: 10.1097/SLA.0000000000002893.
PubMed 30138162
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Versus Laparoscopic Pancreaticoduodenectomy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07328607
- Acronym / sponsor ID
- 1838/12/2025
- Conditions
- Pancreatic Ductal Adenocarcinoma, Ampullary Carcinoma, Distal Cholangiocarcinoma, Duodenal Adenocarcinoma, Pancreatic Neuroendocrine Tumor
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 17 Jan 2026 (actual)
- Primary completion
- 15 Jan 2028 (estimated)
- Study completion
- 15 Apr 2028 (estimated)
- First posted
- 9 Jan 2026 (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.
This is a monocentric, prospective, randomized controlled trial comparing the safety and efficacy of laparoscopic pancreaticoduodenectomy (LPD) versus open pancreaticoduodenectomy (OPD). The study aims to determine the morbimortality of the laparoscopic approach compared to the gold standard open approach in adult patients with pancreatic or periampullary lesions.
Detailed description
This is a monocentric, prospective, randomized controlled trial comparing the safety and efficacy of laparoscopic pancreaticoduodenectomy (LPD) versus open pancreaticoduodenectomy (OPD). The study aims to determine the morbimortality of the laparoscopic approach compared to the gold standard open approach in adult patients with pancreatic or periampullary lesions.
This study will randomize 90 eligible patients to receive either LPD or OPD. The primary objective is to compare overall morbidity using the Clavien-Dindo Classification at 90 days postoperative. Secondary objectives include assessment of oncologic outcomes (lymph node harvest, margin status), perioperative metrics (operative time, blood loss), and postoperative recovery (length of stay, readmissions). The study utilizes a prospectively maintained database and adheres to CONSORT guidelines.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Open Pancreaticoduodenectomy (OPD) | Active comparator | Procedure: Open PancreaticoduodenectomyPatients randomized to receive standard open pancreaticoduodenectomy through a bilateral subcostal incision. |
| Laparoscopic Pancreaticoduodenectomy (LPD) | Experimental | Procedure: Laparoscopic PancreaticoduodenectomyPatients randomized to receive total laparoscopic pancreaticoduodenectomy using a standardized six-port technique. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥18 years.
- Histologically confirmed or clinically suspected lesions of: Pancreatic head adenocarcinoma, Ampullary carcinoma, Distal cholangiocarcinoma, Duodenal adenocarcinoma, Pancreatic neuroendocrine tumors, or Intraductal Papillary Mucinous Neoplasm(IPMN) .
- Resectable disease based on preoperative imaging.
- Eastern Cooperative Oncology Group(ECOG) performance status 0-2.
- American Society of Anesthesiologists(ASA )classification I-III.
Key exclusion criteria (10 listed)
- Emergency surgery.
- Previous pancreatic surgery.
- Concurrent major abdominal procedures .
- ASA classification IV or higher.
- Metastatic disease identified preoperatively.
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 |
|---|---|---|
| Open PancreaticoduodenectomyOpen Pancreaticoduodenectomy with lymphadenectomy and reconstruction via open technique. | Procedure or surgery | Open Pancreaticoduodenectomy (OPD) |
| Laparoscopic PancreaticoduodenectomyMinimally invasive Whipple procedure using 6 trocars, with specimen extraction via Pfannenstiel incision. | Procedure or surgery | Laparoscopic Pancreaticoduodenectomy (LPD) |
Primary outcome
Overall Morbidity (Clavien-Dindo Classification)
Time frame: 90 days postoperative.
Assessment of all surgical complications graded by severity using the Clavien-Dindo Classification (Grades I-V). Major complications are defined as Grade III or higher.
5 secondary outcomes
Number of Lymph Nodes Retrieved
Time frame: 14 days postoperative.
Resection Margin Status (R0/R1/R2)
Time frame: 14 days postoperative.
Operative Time
Time frame: Intraoperative
Estimated Blood Loss
Time frame: Intraoperative
Length of Hospital Stay
Time frame: Up to 90 days.
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 21 Jan 2026.
- Results publication: PubMed 26158612Adam MA, Choudhury K, Dinan MA, Reed SD, Scheri RP, Blazer DG 3rd, Roman SA, Sosa JA. Minimally Invasive Versus Open Pancreaticoduodenectomy for Cancer: Practice Patterns and Short-term Outcomes Among 7061 Patients. Ann Surg. 2015 Aug;262(2):372-7. doi: 10.1097/SLA.0000000000001055.
- Results publication: PubMed 30138162Poves I, Burdio F, Morato O, Iglesias M, Radosevic A, Ilzarbe L, Visa L, Grande L. Comparison of Perioperative Outcomes Between Laparoscopic and Open Approach for Pancreatoduodenectomy: The PADULAP Randomized Controlled Trial. Ann Surg. 2018 Nov;268(5):731-739. doi: 10.1097/SLA.0000000000002893.
- 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 Open Pancreaticoduodenectomy and Laparoscopic Pancreaticoduodenectomy in people with Pancreatic Ductal Adenocarcinoma and Ampullary Carcinoma, 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 6 inclusion and 10 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 21 Jan 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?
Overall Morbidity (Clavien-Dindo Classification) (time frame: 90 days postoperative.). 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 NCT07328607, 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 21 Jan 2026.