Periampullary CarcinomaNCT07388082
Total Laparoscopic vs Open Pancreaticoduodenectomy for the Treatment of Periampullary Adenocarcinomas
A study testing Conventional open pancreaticoduedectomy and Total laparoscopic pancreaticoduedectomy in people with Periampullary Carcinoma, run by Theodor Bilharz Research Institute at 1 site in Egypt.
Trial summary
Laparoscopic pancreaticoduodenectomy (LPD), a surgical option for nonpancreatic periampullary adenocarcinoma (NPPA), is a complex procedure that has become increasing popular. However, there is no consensus as to whether this technique should be performed routinely. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Periampullary Carcinoma
- What is being tested?
- Conventional open pancreaticoduedectomy and Total laparoscopic pancreaticoduedectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Aug 2023to 5 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- • Body mass index <28.0 kg/m2.
- Ampullary tumors, duodenal tumors restricted to the second part of the duodenum, or lower common bile duct tumors.
- Carefully confirmed resectability of the tumors based on preoperative radiology conducted by experienced radiologists and surgeons.
Who cannot join
- • Patients with >180 degrees superior mesenteric artery encasement
- Any celiac abutment.
- Unreconstructable superior mesenteric vein/portal occlusion" Aortic invasion or encasement.
- A history of previous upper abdominal surgery.
- Tumors extending to the uncinate.
- Severe cardiorespiratory comorbidities.
Trial locations and contacts
1 site in 1 country.
About this study
Laparoscopic pancreaticoduodenectomy (LPD), a surgical option for nonpancreatic periampullary adenocarcinoma (NPPA), is a complex procedure that has become increasing popular. However, there is no consensus as to whether this technique should be performed routinely. Our aim was to evaluate the outcomes of LPD compared with open pancreaticoduodenectomy (OPD).
- Conditions
- Periampullary Carcinoma
- Being tested
- Conventional open pancreaticoduedectomy, Total laparoscopic pancreaticoduedectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional open pancreaticoduedectomyProcedure or surgery
Fifteen patients in Group A had a traditional open pancreaticoduedectomy.
Total laparoscopic pancreaticoduedectomyProcedure or surgery
Fifteen patients in Group A had a total laparoscopic pancreaticoduedectomy.
| Study group | Role | What they receive |
|---|---|---|
| conventional open pancreaticoduedectomy | Active comparator | 15 patients underwent conventional open pancreaticoduedenctomy Receives: Procedure: Conventional open pancreaticoduedectomy |
| Total laparoscopic pancreaticoduedectomy | Active comparator | 15 patients underwent total laparoscopic pancreaticoduedectomy Receives: Procedure: Total laparoscopic pancreaticoduedectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of pancreatic fistula after laparoscopic pancreaticoduodenectomy in comparison to open surgery
Laparoscopic pancreaticoduodenectomy is a complex procedure that has become increasing popular. However, there is no consensus as to whether this technique should be performed routinely.
Our aim was to evaluate the outcomes of Laparoscopic pancreaticoduodenectomy compared with open pancreaticoduodenectomy.
Measured: in 2 years between 2023 - 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2026
- Study start5 Aug 2023
- Primary completion5 Aug 2025
- Study completion5 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Periampullary CarcinomaStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Theodor Bilharz Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Rady, Theodor Bilharz Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07388082
- Sponsor's protocol ID
- PT (670)
- Status last verified
- Dec 2025
- First submitted
- 7 Dec 2025
- Last updated
- 23 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Paniccia A, Schulick RD, Edil BH. Total Laparoscopic Pancreaticoduodenectomy: A Single-Institutional Experience. Ann Surg Oncol. 2015 Dec;22(13):4380-1. doi: 10.1245/s10434-015-4450-2. Epub 2015 Apr 18.
PubMed 25893407
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Total Laparoscopic vs Open Pancreaticoduodenectomy for the Treatment of Periampullary Adenocarcinomas
- ClinicalTrials.gov ID
- NCT07388082
- Acronym / sponsor ID
- PT (670)
- Conditions
- Periampullary Carcinoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Theodor Bilharz Research InstituteUniversity, hospital or other
- Study start
- 5 Aug 2023 (actual)
- Primary completion
- 5 Aug 2025 (actual)
- Study completion
- 5 Oct 2025 (actual)
- First posted
- 4 Feb 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.
Laparoscopic pancreaticoduodenectomy (LPD), a surgical option for nonpancreatic periampullary adenocarcinoma (NPPA), is a complex procedure that has become increasing popular. However, there is no consensus as to whether this technique should be performed routinely. Our aim was to evaluate the outcomes of LPD compared with open pancreaticoduodenectomy (OPD).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventional open pancreaticoduedectomy | Active comparator | Procedure: Conventional open pancreaticoduedectomy15 patients underwent conventional open pancreaticoduedenctomy |
| Total laparoscopic pancreaticoduedectomy | Active comparator | Procedure: Total laparoscopic pancreaticoduedectomy15 patients underwent total laparoscopic pancreaticoduedectomy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- • Body mass index <28.0 kg/m2.
Key exclusion criteria (6 listed)
- • Patients with >180 degrees superior mesenteric artery encasement
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 |
|---|---|---|
| Conventional open pancreaticoduedectomyFifteen patients in Group A had a traditional open pancreaticoduedectomy. | Procedure or surgery | conventional open pancreaticoduedectomy |
| Total laparoscopic pancreaticoduedectomyFifteen patients in Group A had a total laparoscopic pancreaticoduedectomy. | Procedure or surgery | Total laparoscopic pancreaticoduedectomy |
Primary outcome
The incidence of pancreatic fistula after laparoscopic pancreaticoduodenectomy in comparison to open surgery
Time frame: in 2 years between 2023 - 2025
Laparoscopic pancreaticoduodenectomy is a complex procedure that has become increasing popular. However, there is no consensus as to whether this technique should be performed routinely. Our aim was to evaluate the outcomes of Laparoscopic pancreaticoduodenectomy compared with open pancreaticoduodenectomy.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2026.
- Results publication: PubMed 25893407Paniccia A, Schulick RD, Edil BH. Total Laparoscopic Pancreaticoduodenectomy: A Single-Institutional Experience. Ann Surg Oncol. 2015 Dec;22(13):4380-1. doi: 10.1245/s10434-015-4450-2. Epub 2015 Apr 18.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional open pancreaticoduedectomy and Total laparoscopic pancreaticoduedectomy in people with Periampullary Carcinoma, run by Theodor Bilharz Research Institute 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 3 inclusion and 6 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: finished, as of the sponsor's last update on 23 Feb 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of pancreatic fistula after laparoscopic pancreaticoduodenectomy in comparison to open surgery (time frame: in 2 years between 2023 - 2025). 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 NCT07388082, which also lists 1 linked publication.
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 23 Feb 2026.