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New treatment option for Pancreatic Cancer
Official title Tissue Adhesive Glue Modified Cyanoacrylate (Glubran® 2) in Soft Pancreas
ClinicalTrials.gov ID: NCT07155525
What this study is testing
What is Pancreaticojejunostomy with Modified N-Butyl-2-Cyanoacrylate (Glubran® 2)?
Pancreaticojejunostomy with Modified N-Butyl-2-Cyanoacrylate (Glubran® 2) is an investigational medicine, given as an once-daily treatment applied to the skin, being studied as a potential treatment for pancreatic cancer.
Also referred to as Tissue Adhesive, Cyanoacrylate Glue,Glubran® 2.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a single-center, randomized controlled trial comparing the efficacy of pancreaticojejunostomy with modified N-butyl-2-cyanoacrylate(Glubran® 2) versus standard pancreaticojejunostomy without cyanoacrylate in preventing postoperative pancreatic fistula (POPF) in patients undergoing pancreaticoduodenectomy with soft pancreatic texture. The primary endpoint is the incidence of postoperative pancreatic fistula at 30 days post-surgery, as defined by the International Study Group on Pancreatic Fistula (ISGPF) criteria.Secondary outcomes include surgical complications and length of hospital stay.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Patients scheduled for elective pancreaticoduodenectomy for malignant lesions.
- Intraoperative confirmation of soft pancreatic texture (by surgeon palpation; friable, non-fibrotic pancreas).
- Age 18-75 years .
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
- Adequate organ function defined as: Hemoglobin ≥ 9.0 g/dL Absolute neutrophil count ≥ 1,500/μL Platelet count ≥ 100,000/μL Total bilirubin ≤ 3 times...
You likely can't join if
- Hard pancreatic texture (intraoperative surgeon assessment).
- Emergency surgery.
- Previous pancreatic surgery or pancreatic anastomosis.
- Intraoperative identification of unresectable disease
- Known allergy to cyanoacrylate or components.
- Pregnancy or lactation.
See the full eligibility criteria
- Patients scheduled for elective pancreaticoduodenectomy for malignant lesions.
- Intraoperative confirmation of soft pancreatic texture (by surgeon palpation; friable, non-fibrotic pancreas).
- Age 18-75 years .
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
- Adequate organ function defined as: Hemoglobin ≥ 9.0 g/dL Absolute neutrophil count ≥ 1,500/μL Platelet count ≥ 100,000/μL Total bilirubin ≤ 3 times upper limit of normal Alanine transaminase (ALT) /Alanine transaminase...
- Informed consent provided.
- Willingness to comply with study procedures and follow-up requirements.
- Hard pancreatic texture (intraoperative surgeon assessment).
- Emergency surgery.
- Previous pancreatic surgery or pancreatic anastomosis.
- Intraoperative identification of unresectable disease
- Known allergy to cyanoacrylate or components.
- Pregnancy or lactation.
- Active infection or sepsis.
- Inability to comply with follow-up.
The study team makes the final eligibility decision.
Where it's taking place
- Minya, Minya Governorate, Egypt
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Minya, Minya Governorate, Egypt. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.