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New treatment option for Pancreas Head Cancer
Official title Preventing Postoperative Complications in Patients Undergoing High-risk Pancreatoduodenectomy With a Bundle Approach Including Hydrocortisone, Octreotide, and the Teres Ligament Patch (PANENCA)
ClinicalTrials.gov ID: NCT07262957
What this study is testing
What is HOP bundle?
HOP bundle is an investigational medicine, given as an once-daily injection under the skin, being studied as a potential treatment for pancreas head cancer.
Also referred to as Hydrocortisone, Octreotide.
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
- The PANENCA trial aims to reduce postoperative complications in patients undergoing pancreatoduodenectomy (also known as a Whipple procedure), a complex surgical operation performed to remove tumors located in or near the head of the pancreas. One of the most frequent and serious complications after this surgery is postoperative pancreatic fistula (POPF), a leakage of pancreatic fluid from the surgical connection.
- Phase 4: studies an already-approved treatment
- 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 and older
You may be able to join if
- Elective pancreatoduodenectomy for any indication (both minimally invasive and open)
- Pancreatic duct diameter ≤ 3mm on preoperative CT or MRI\
- 18 years of age or older
- Signature of informed consent
- In the opinion of the investigator, the patient is eligible for the administration of hydrocortisone and octreotide, based on contraindications...
You likely can't join if
- Age \< 18 years
- Pregnancy or current breastfeeding
- Known allergy or hypersensitivity to hydrocortisone or octreotide
- Systemic fungal infection
- Concomitant use of strong CYP3A4 inhibitors or moderate-to-strong inducers that cannot be discontinued (see CYTOCHROME P450 DRUG INTERACTION TABLE...
- Inhibitors must be discontinued ≥7 days before randomization
See the full eligibility criteria
- Elective pancreatoduodenectomy for any indication (both minimally invasive and open)
- Pancreatic duct diameter ≤ 3mm on preoperative CT or MRI\
- 18 years of age or older
- Signature of informed consent
- In the opinion of the investigator, the patient is eligible for the administration of hydrocortisone and octreotide, based on contraindications, warnings, and precautions as listed in the respective SmPCs
- Age \< 18 years
- Pregnancy or current breastfeeding
- Known allergy or hypersensitivity to hydrocortisone or octreotide
- Systemic fungal infection
- Concomitant use of strong CYP3A4 inhibitors or moderate-to-strong inducers that cannot be discontinued (see CYTOCHROME P450 DRUG INTERACTION TABLE (iu.edu))
- Inhibitors must be discontinued ≥7 days before randomization
- Inducers must be discontinued ≥28 days before randomization
The study team makes the final eligibility decision.
Where it's taking place
- Amsterdam, Netherlands
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Amsterdam, Netherlands. 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.