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Preventing postoperative complications in patients undergoing high-risk pancreatoduodenectomy with a bundle approach including hydrocortisone, ocreotide, and teres ligament patch (PANENCA): an international randomized controlled multicenter trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-519667-18-00
Acronym
1.1
Enrollment
400
Registered
2025-07-23
Start date
2025-08-21
Completion date
Unknown
Last updated
2025-10-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic conditions requiring pancreaticoduodenectomy, such as pancreatic head carcinoma or intraductal papillary mucinous neoplasms (IPMN).

Brief summary

Rate of Major Complications, defined as a Clavien-Dindo score of ≥III and/or postoperative abdominal drain placement

Detailed description

Rate of postoperative pancreatic fistula (POPF)* grade B/C. as defined by the international studygroup for pancreatic surgery (ISGPS), Rate of delayed gastric emptying (DGE) according to the ISGPS definition, Rate of post pancreatectomy hemorrhage (PPH) according to the ISGPS definition, Rate of chyle leakage (CL) according to the ISGPS definition, Rate of bile leakage (BL) according to the ISGPS definition, Rate of post-pancreatectomy acute pancreatitis (PPAP), Reintervention during admission/re-admission (either radiological, surgical or endoscopic), Adverse drug reactions to hydrocortisone and octreotide, Multi-organ failure during admission/re-admission, ICU admission, Time to functional recovery, Length of hospital stay in days during admission/re-admission, Readmission within 90 days after surgery, In-hospital and 90-day mortality

Interventions

DRUGOctreotide Lyomark 0
DRUG1 mg/ml oplossing voor injectie
DRUGpoeder voor injectievloeistof
DRUG100 mg

Sponsors

Amsterdam UMC Stichting
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Rate of Major Complications, defined as a Clavien-Dindo score of ≥III and/or postoperative abdominal drain placement

Secondary

MeasureTime frame
Rate of postoperative pancreatic fistula (POPF)* grade B/C. as defined by the international studygroup for pancreatic surgery (ISGPS), Rate of delayed gastric emptying (DGE) according to the ISGPS definition, Rate of post pancreatectomy hemorrhage (PPH) according to the ISGPS definition, Rate of chyle leakage (CL) according to the ISGPS definition, Rate of bile leakage (BL) according to the ISGPS definition, Rate of post-pancreatectomy acute pancreatitis (PPAP), Reintervention during admission/re-admission (either radiological, surgical or endoscopic), Adverse drug reactions to hydrocortisone and octreotide, Multi-organ failure during admission/re-admission, ICU admission, Time to functional recovery, Length of hospital stay in days during admission/re-admission, Readmission within 90 days after surgery, In-hospital and 90-day mortality

Countries

Finland, Italy, Netherlands, Norway, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026