Enhanced Recovery After Minimally Invasive Pancreaticoduodenectomy

NCT02671357 | Completed

• 1 other identifier: ERAMIP
• Study Type: observational
• Target: 210
• Locations: 1 country
• Sites: 1

Brief Summary

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

Pancreatic Neoplasms; Periampullary Neoplasms

Keywords

pancreatic surgery; neoplasms

Outcome Measures

Primary Outcomes (1)

• The incidence of severe complications

  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

  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

Secondary Outcomes (1)

• Postoperative in-hospital, 30-day and 90-day mortality

  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 month

Other Outcomes (4)

• Clinical postoperative pancreatic fistula (POPF) rate

  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

• Postoperative bleeding (PPH) rate

  From date of discharge from hospital until date of re-admission to hospital within 2 weeks after discharge, assessed up to 3 months

• Length of postoperative hospital stay (LOS)

  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. Readmissions within 30days after discharge will be added to the duration of LOS.

Study Arms (1)

ERAMIP with EEN

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

Procedure: ERAMIP

Interventions

ERAMIP PROCEDURE

3D-LPD with stented umbrella-pancreaticogastrostomy \& Roux-en-Y reconstruction of the biliary limb of the hepatico-jejunostomy onto the efferent limb of the gastro-enterostomy (RY-GES)

ERAMIP with EEN

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with pancreatic or peri-ampullarf neoplasms to undergo minimally invasive pancreaticoduodenectomy

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Gasthuisberg: lead

Study Sites (1)

University Hospitals KU Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

Location

Related Publications (3)

• Topal 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 BACKGROUND

• Williamsson 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 BACKGROUND

• Topal 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 DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Baki Topal, MD, PhD

  University Hospitals KU Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Doctor

Study Record Dates

• First Submitted: January 22, 2016
• First Posted: February 2, 2016
• Study Start: March 1, 2016
• Primary Completion: June 1, 2019
• Study Completion: June 1, 2019
• Last Updated: March 26, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)