Clinical trial · Interventional
Safety and Feasibility Study of Enhanced Recovery in Pancreaticoduodenectomy
Safety and Feasibility Study of an Enhanced Recovery After Surgery Protocol in Patients Undergoing Elective Pancreaticoduodenectomy.
NCT01759706CI-TRIAL-00016260completedN/AClinicalTrials.gov clinicaltrialsProvenance
- 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 purpose of this study is to assess the adherence to an enhanced recovery after surgery (ERAS) pathway and the impact of the ERAS protocol on postoperative short-term outcome in patients undergoing pancreaticoduodenectomy (PD).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Neoplasms | Pancreatic Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (8)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Enhanced recovery after surgery protocol | Behavioral | — | UNRESOLVED |
| Epidural analgesia with naropin + sufentanil | Drug | — | UNRESOLVED |
| PONV prophylaxis with Ondansetron + Dexamethasone | Drug | — | UNRESOLVED |
| Postoperative mobilization program | Other | — | UNRESOLVED |
| Preadmission counselling | Behavioral | — | UNRESOLVED |
| Pre-anesthetic medication with diazepam | Drug | — | UNRESOLVED |
| Preoperative bowel preparation with sodium phosphate | Drug | — | UNRESOLVED |
| Standard perioperative care | Procedure |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Enhanced Recovery After Surgery (ERAS)
- description
- Patients treated with enhanced recovery after surgery protocol: preadmission counselling, preoperative immunonutrition, no preoperative bowel preparation, epidural analgesia with naropin + sufentanil, no pre-anesthetic medication, intraoperative iv fluid restriction, PONV prophylaxis with ondansetron + dexamethasone, hypothermia prophylaxis, removal of nasogastric tube (NGT) at the end of surgery, postoperative mobilization program, solid food diet from POD 2, early stop of iv infusions and removal of urinary catheter.
- interventionNames
- Behavioral: Enhanced recovery after surgery protocol
- Drug: PONV prophylaxis with Ondansetron + Dexamethasone
- Other: Postoperative mobilization program
- Drug: Epidural analgesia with naropin + sufentanil
- Behavioral: Preadmission counselling
- type
- ACTIVE_COMPARATOR
- label
- Standard perioperative care (Control)
- description
- Patients treated with standard care perioperative protocol: epidural analgesia with naropin + sufentanil, pre-anesthetic medication with diazepam, Preoperative bowel preparation with sodium phosphate, removal of nasogastric tube on POD 1, solid food diet from POD 4
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * All patients undergoing elective pancreaticoduodenectomy Exclusion Criteria: * Intraoperative detection of metastatic disease (non-operability)
References
Publications (2)
- BACKGROUNDBalzano G, Zerbi A, Braga M, Rocchetti S, Beneduce AA, Di Carlo V. Fast-track recovery programme after pancreatico- duodenectomy reduces delayed gastric emptying. Br J Surg. 2008 Nov;95(11):1387-93. doi: 10.1002/bjs.6324. PMID 18844251
- BACKGROUNDLassen K, Coolsen MM, Slim K, Carli F, de Aguilar-Nascimento JE, Schafer M, Parks RW, Fearon KC, Lobo DN, Demartines N, Braga M, Ljungqvist O, Dejong CH; Enhanced Recovery After Surgery (ERAS) Society, for Perioperative Care; European Society for Clinical Nutrition and Metabolism (ESPEN); International Association for Surgical Metabolism and Nutrition (IASMEN). Guidelines for perioperative care for pancreaticoduodenectomy: Enhanced Recovery After Surgery (ERAS(R)) Society recommendations. World J Surg. 2013 Feb;37(2):240-58. doi: 10.1007/s00268-012-1771-1. No abstract available. PMID 22956014