Clinical trial · Observational
Reduced Intra-operative Blood Loss in Pancreaticoduodenectomy for Pancreatic or Peri-ampullary Tumors; Monocentric Trial on Standard Open Versus Minimally Invasive Surgery
Reduced Intra-operative Blood Loss in Pancreaticoduodenectomy for Pancreatic or Peri-ampullary Tumors; Monocentric Randomized Trial on Standard Open Versus Minimally Invasive Surgery
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The incidence of complications after standard open pancreaticoduodenectomy for pancreatic or peri-ampullary tumours is around 50%. The amount of intra-operative blood loss is an important factor that determines the occurrence of postoperative complications. Therefore, any significant reduction of intra-operative blood loss will benefit the peri-operative course.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Blood Loss | — | UNRESOLVED | — |
| Pancreatic Tumour | Pancreatic Neoplasm | ALIAS | 0.90 |
| Peri-ampullary Tumour | — | UNRESOLVED | — |
| Surgery | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- OPD
- description
- standard open pancreaticoduodenectomy
- label
- LPD
- description
- laparoscopic pancreaticoduodenectomy
Primary outcomes (1)
- measure
- intra-operative blood loss
- timeFrame
- day 0 (at the end of surgery)
- description
- the amount of intra-operative blood loss (ml) at the end of surgery (d0)
Secondary outcomes (3)
- measure
- Surgical resection margin
- timeFrame
- day 30
- description
- Histopathological examination of surgical resection margins of the resection specimen; done within 30 days after surgery pR0: tumour-free resection margins pR1: tumour involvement of surgical resection margins
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Patients, male or female, who undergo PD for a pancreatic or peri-ampullary tumor * Age between 18 to 80 years * Patients with and without pre-operative biliary drainage (for obstructive jaundice) * Pre-operative radiotherapy, chemotherapy, or biological is allowed * PD for IPMN is allowed Exclusion Criteria: * Planned concomitant surgical procedures such as simultaneous colonic resection etc. * Expected/planned reconstruction of the portal vein or superior mesenteric vein * Any arterial reconstruction at the time of surgery * Age \< 18years * Pregnancy * PD for chronic pancreatitis * PD for pancreatic trauma * PD for post-ERCP complications
References
Publications (0)
Data not yet available