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Enhanced Recovery After Minimally Invasive Pancreaticoduodenectomy (ERAMIP)

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ClinicalTrials.gov Identifier: NCT02671357
Recruitment Status : Completed
First Posted : February 2, 2016
Last Update Posted : March 26, 2020
Sponsor:
Information provided by (Responsible Party):
Baki Topal, University Hospital, Gasthuisberg

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).

Condition or disease Intervention/treatment
Pancreatic Neoplasms; Periampullary Neoplasms Procedure: ERAMIP

Detailed Description:

Pancreaticoduodenectomy (PD) is the standard of care for patients with malignant or benign disease of the pancreatic head or peri-ampullary region. The postoperative course after PD is strongly dependent of the occurrence of pancreatic fistula (POPF) and/or delayed gastric emptying (DGE). In a recent multicentre randomized controlled trial, the investigators have shown pancreaticogastrostomy (PG; without a stent in the pancreatic duct) to be associated with 8% POPF rate, significantly lower than pancreaticojejunostomy (20%) (1). Since then, PG reconstruction is considered the standard of care in PD, which is also underlined in more recent systematic reviews.

In patients without POPF after PD, the length of hospital stay is determined by the occurrence of DGE, which is poorly understood and currently lacks any effective treatment. Patients who developed DGE after PD with PG anastomosis (n=18; 20%) had a significantly (p=0.014) longer (mean + sem) length of hospital stay (LOS) of 26.3 + 1.58 days, as compared to 22.4 + 1.27 days for patients without DGE (n=69). These figures are observed in the investigators' center as part of the multicentre RCT.

Enhanced recovery after surgery (ERAS) or fast-track (FT) programs are able to reduce postoperative length of hospital stay (LOS). Indeed recently, ERAS or FT programs have been implemented successfully in PD (2). Patients were discharged 4 days earlier in the ERAS group, without a negative effect on the clinical outcome. Still, many surgeons are reluctant to implement ERAS programs because they fear compromising patient safety.

In efforts to improve the outcomes of PD, many surgical techniques have been evaluated to restore the pancreatic digestive continuity after PD. However, the best way to ensure this and whether or not to perform the procedure via standard open or minimally invasive, i.e. 2- or 3-dimensional laparoscopic (3D-LPD) or 3-dimensional robotic surgery (RPD), is still under debate. The investigators have passed the learning curve of 50 3D-LPD and hypothesize the implementation of ERAS and EEN in 3D-LPD can improve short-term outcomes.

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Study Type : Observational
Actual Enrollment : 210 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Enhanced Recovery After Minimally Invasive Pancreaticoduodenectomy With Stented Pancreaticogastrostomy and Roux-en-y Gastro-enterostomy
Actual Study Start Date : March 2016
Actual Primary Completion Date : June 2019
Actual Study Completion Date : June 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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
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)




Primary Outcome Measures :
  1. The incidence of severe complications [ Time Frame: 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 ]
    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 Outcome Measures :
  1. Postoperative in-hospital, 30-day and 90-day mortality [ Time Frame: 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 ]
    Postoperative mortality rate


Other Outcome Measures:
  1. Clinical postoperative pancreatic fistula (POPF) rate [ Time Frame: 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 ]
    The incidence of POPF will be registered and defined according to the ISGPF

  2. Postoperative bleeding (PPH) rate [ Time Frame: From date of discharge from hospital until date of re-admission to hospital within 2 weeks after discharge, assessed up to 3 months ]
    The incidence of PPH will be registered and defined according to the ISGPF

  3. Length of postoperative hospital stay (LOS) [ Time Frame: 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. ]
    Length of hospital stay (days) will be registered starting from the day of surgery until discharge

  4. Delayed gastric emptying (DGE) rate [ Time Frame: 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 ]
    The incidence of DGE will be registered and defined according to the ISGPF



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with pancreatic or peri-ampullarf neoplasms to undergo minimally invasive pancreaticoduodenectomy
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02671357


Locations
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Belgium
University Hospitals KU Leuven
Leuven, Vlaams-Brabant, Belgium, 3000
Sponsors and Collaborators
University Hospital, Gasthuisberg
Investigators
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Principal Investigator: Baki Topal, MD, PhD University Hospitals KU Leuven
Publications:
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Responsible Party: Baki Topal, Professor, Doctor, University Hospital, Gasthuisberg
ClinicalTrials.gov Identifier: NCT02671357    
Other Study ID Numbers: ERAMIP
First Posted: February 2, 2016    Key Record Dates
Last Update Posted: March 26, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Baki Topal, University Hospital, Gasthuisberg:
pancreatic surgery; neoplasms
Additional relevant MeSH terms:
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Neoplasms
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases