Periampullary Carcinoma ResectablePhase 4NCT07333755
New Technique of End-to-Side Two-Layered Duct-to-Mucosa Pancreaticojejunostomy With Omental Wrapping and Glue (Glubran 2) During Laparoscopic Whipple Operation
A Phase 4 study testing Pancreaticojejunostomy without omental patch and Pancreaticojejunostomy with omental patch and glue in people with Periampullary Carcinoma Resectable, run by Theodor Bilharz Research Institute at 1 site in Egypt.
Trial summary
Following pancreaticoduodenectomy, omental flaps around the pancreatic anastomosis and adhesive glue can lower the risk of pancreatic fistula, post-pancreatectomy bleeding, and delayed gastric emptying. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Periampullary Carcinoma Resectable
- What is being tested?
- Pancreaticojejunostomy without omental patch and Pancreaticojejunostomy with omental patch and glue
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Nov 2023to 5 Nov 2025
- Phase
- Phase 4
- 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
- Resectable tumors of the periampullary region
Who cannot join
- Pancreatic or duodenal tumors
- Irresectability criteria (such as metastases, ascites, or arterial vascular invasion)
Trial locations and contacts
1 site in 1 country.
About this study
Following pancreaticoduodenectomy, omental flaps around the pancreatic anastomosis and adhesive glue can lower the risk of pancreatic fistula, post-pancreatectomy bleeding, and delayed gastric emptying. The overall morbidity following pancreaticoduodenectomy can be decreased with this straightforward and efficient treatment.
- Conditions
- Periampullary Carcinoma Resectable
- Being tested
- Pancreaticojejunostomy without omental patch, Pancreaticojejunostomy with omental patch and glue
- Keywords
- pancreaticoduodenectomy, omental flaps, Laparoscopic whipple operation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pancreaticojejunostomy without omental patchProcedure or surgery
A laparoscopic pancreaticoduodenectomy with pylorus preservation was performed on each patient. A pancreatojejunostomy was created and not fixed with an omental patch or glue.
Pancreaticojejunostomy with omental patch and glueProcedure or surgery
A laparoscopic pancreaticoduodenectomy was performed on each patient. A pancreaticojejunostomy was fixed with glue to secure the anastomosis. The greater omentum was separated longitudinally over an avascular zone, and one or two omental branches of the gastroepiploic arteries were preserved using pedicle omental flaps. The omentum was rolled up and secured with glue.
| Study group | Role | What they receive |
|---|---|---|
| A double-layered, end-to-side pancreaticojejunostomy without omental patch or glue | Active comparator | Not described Receives: Procedure: Pancreaticojejunostomy without omental patch |
| A double-layered, end-to-side pancreaticojejunostomy with omental patch and Glue | Active comparator | Not described Receives: Procedure: Pancreaticojejunostomy with omental patch and glue |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of pancreatic fistula after pancreaticoduodenectomy
Measured: 4 weeks postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2026
- Study start5 Nov 2023
- Primary completion5 Nov 2025
- Study completion5 Nov 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 Carcinoma ResectableStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 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
- NCT07333755
- Sponsor's protocol ID
- PT (672)
- Status last verified
- Nov 2025
- First submitted
- 30 Dec 2025
- Last updated
- 12 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be shared upon request from the principle investigator.
Publications
Maeda A, Ebata T, Kanemoto H, Matsunaga K, Bando E, Yamaguchi S, Uesaka K. Omental flap in pancreaticoduodenectomy for protection of splanchnic vessels. World J Surg. 2005 Sep;29(9):1122-6. doi: 10.1007/s00268-005-7900-3.
PubMed 16132400
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Technique of End-to-Side Two-Layered Duct-to-Mucosa Pancreaticojejunostomy With Omental Wrapping and Glue (Glubran 2) During Laparoscopic Whipple Operation
- ClinicalTrials.gov ID
- NCT07333755
- Acronym / sponsor ID
- PT (672)
- Conditions
- Periampullary Carcinoma Resectable
- Keywords
- pancreaticoduodenectomy, omental flaps, Laparoscopic whipple operation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Theodor Bilharz Research InstituteUniversity, hospital or other
- Study start
- 5 Nov 2023 (actual)
- Primary completion
- 5 Nov 2025 (actual)
- Study completion
- 5 Nov 2025 (actual)
- First posted
- 12 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.
Following pancreaticoduodenectomy, omental flaps around the pancreatic anastomosis and adhesive glue can lower the risk of pancreatic fistula, post-pancreatectomy bleeding, and delayed gastric emptying. The overall morbidity following pancreaticoduodenectomy can be decreased with this straightforward and efficient treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A double-layered, end-to-side pancreaticojejunostomy without omental patch or glue | Active comparator | Procedure: Pancreaticojejunostomy without omental patch |
| A double-layered, end-to-side pancreaticojejunostomy with omental patch and Glue | Active comparator | Procedure: Pancreaticojejunostomy with omental patch and glue |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Resectable tumors of the periampullary region
Key exclusion criteria (2 listed)
- Pancreatic or duodenal tumors
- Irresectability criteria (such as metastases, ascites, or arterial vascular invasion)
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 |
|---|---|---|
| Pancreaticojejunostomy without omental patchA laparoscopic pancreaticoduodenectomy with pylorus preservation was performed on each patient. A pancreatojejunostomy was created and not fixed with an omental patch or glue. | Procedure or surgery | A double-layered, end-to-side pancreaticojejunostomy without omental patch or glue |
| Pancreaticojejunostomy with omental patch and glueA laparoscopic pancreaticoduodenectomy was performed on each patient. A pancreaticojejunostomy was fixed with glue to secure the anastomosis. The greater omentum was separated longitudinally over an avascular zone, and one or two omental branches of the gastroepiploic arteries were preserved using pedicle omental flaps. The omentum was rolled up and secured with glue. | Procedure or surgery | A double-layered, end-to-side pancreaticojejunostomy with omental patch and Glue |
Primary outcome
The rate of pancreatic fistula after pancreaticoduodenectomy
Time frame: 4 weeks postoperative
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 12 Jan 2026.
- Results publication: PubMed 16132400Maeda A, Ebata T, Kanemoto H, Matsunaga K, Bando E, Yamaguchi S, Uesaka K. Omental flap in pancreaticoduodenectomy for protection of splanchnic vessels. World J Surg. 2005 Sep;29(9):1122-6. doi: 10.1007/s00268-005-7900-3.
- Individual participant dataSharing planned: Yes. The data will be shared upon request from the principle investigator.
Related trials for Periampullary Carcinoma Resectable
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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 Phase 4 study testing Pancreaticojejunostomy without omental patch and Pancreaticojejunostomy with omental patch and glue in people with Periampullary Carcinoma Resectable, 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 1 inclusion and 2 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 12 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 rate of pancreatic fistula after pancreaticoduodenectomy (time frame: 4 weeks 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 NCT07333755, 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 12 Jan 2026.