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Completed

NCT Number: NCT02671357

Enhanced Recovery After Minimally Invasive Pancreaticoduodenectomy

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).

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospitals KU Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital, Gasthuisberg

Other

Registry information

Official study title

Enhanced Recovery After Minimally Invasive Pancreaticoduodenectomy With Stented Pancreaticogastrostomy and Roux-en-y Gastro-enterostomy

Acronym: ERAMIP

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Feb 2, 2016
Registry last updated
Mar 26, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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