Clinical trial · Observational
Enhanced Recovery After Minimally Invasive Pancreaticoduodenectomy
Enhanced Recovery After Minimally Invasive Pancreaticoduodenectomy With Stented Pancreaticogastrostomy and Roux-en-y Gastro-enterostomy
NCT02671357CI-TRIAL-00044261ERAMIPcompletedClinicalTrials.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)
This prospective observational cohort study aims to improve the postoperative course after minimally invasive pancreaticoduodenectomy (MIP) with stented pancreaticogastrostomy (sPG) for pancreatic head or peri-ampullary neoplasms. Patients are submitted to an enhanced recovery after surgery (ERAS) program with early enteral nutrition (EEN).
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; Periampullary Neoplasms | Pancreatic Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ERAMIP | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- ERAMIP with EEN
- description
- Minimally invasive pancreaticoduodenectomy (MIPD) with stented pancreatic-gastrostomy \& Roux-en-Y reconstruction of the biliary limb of the hepatico-jejunostomy onto the efferent limb of the gastro-enterostomy (RY-GES). All patients are submitted to an ERAS trajectory with EEN
- interventionNames
- Procedure: ERAMIP
Primary outcomes (1)
- measure
- The incidence of severe complications
- timeFrame
- From date of pancreaticoduodenectomy until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 3 months
- description
- Severe complications are classified according to the Clavien-Dindo Classification, i.e. Therapy Oriented Severity Grading Score of postoperative complications (TOSGS grade 3 or more): complication that needs interventional therapy under local or general anaesthesia
Secondary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * Patients, male or female, who undergo MIP + sPG for a pancreatic or peri-ampullary tumor * Patients with and without pre-operative biliary drainage (for obstructive jaundice) * Patients fit for minimally invasive pancreaticoduodenectomy (MIP) * Informed consent signed Exclusion Criteria: * Pregnancy * MIP for pancreatic trauma * MIP for complications of endoscopic retrograde cholangio-pancreaticography (ERCP) * Reconstruction of the portal vein or superior mesenteric vein * Any arterial reconstruction at the time of surgery
References
Publications (3)
- BACKGROUNDTopal B, Fieuws S, Aerts R, Weerts J, Feryn T, Roeyen G, Bertrand C, Hubert C, Janssens M, Closset J; Belgian Section of Hepatobiliary and Pancreatic Surgery. Pancreaticojejunostomy versus pancreaticogastrostomy reconstruction after pancreaticoduodenectomy for pancreatic or periampullary tumours: a multicentre randomised trial. Lancet Oncol. 2013 Jun;14(7):655-62. doi: 10.1016/S1470-2045(13)70126-8. Epub 2013 May 2. PMID 23643139
- BACKGROUNDWilliamsson C, Karlsson N, Sturesson C, Lindell G, Andersson R, Tingstedt B. Impact of a fast-track surgery programme for pancreaticoduodenectomy. Br J Surg. 2015 Aug;102(9):1133-41. doi: 10.1002/bjs.9856. Epub 2015 Jun 4. PMID 26042725
- DERIVEDTopal H, Jaekers J, Geers J, Topal B. Prospective cohort study on short-term outcomes of 3D-laparoscopic pancreaticoduodenectomy with stented pancreaticogastrostomy. Surg Endosc. 2023 Feb;37(2):1203-1212. doi: 10.1007/s00464-022-09609-9. Epub 2022 Sep 26. PMID 36163561