Enhanced Recovery After Minimally Invasive Pancreaticoduodenectomy

Pancreatic Neoplasms; Periampullary Neoplasms Clinical Trial

— ERAMIP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02671357
• Other study ID #: ERAMIP
• Status: Completed
• Start date: March 2016
• Est. completion date: June 2019

Study information

• Verified date: March 2020
• Source: University Hospital, Gasthuisberg
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 210
• Est. completion date: June 2019
• Est. primary completion date: June 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Neoplasms
• Pancreatic Neoplasms
• Pancreatic Neoplasms; Periampullary Neoplasms

Intervention

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)

Locations

Country	Name	City	State
Belgium	University Hospitals KU Leuven	Leuven	Vlaams-Brabant

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Gasthuisberg

Country where clinical trial is conducted

Belgium, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Clinical postoperative pancreatic fistula (POPF) rate	The incidence of POPF will be registered and defined according to the ISGPF	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
Other	Postoperative bleeding (PPH) rate	The incidence of PPH will be registered and defined according to the ISGPF	From date of discharge from hospital until date of re-admission to hospital within 2 weeks after discharge, assessed up to 3 months
Other	Length of postoperative hospital stay (LOS)	Length of hospital stay (days) will be registered starting from the day of surgery until discharge	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.
Other	Delayed gastric emptying (DGE) rate	The incidence of DGE will be registered and defined according to the ISGPF	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
Primary	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	Postoperative in-hospital, 30-day and 90-day mortality	Postoperative mortality 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 month