Patient case: 61-year-old male with Ampullary carcinoma. Genetic variant: KRAS. Other conditions: None.

Clinical trial: Enhanced Recovery After Minimally Invasive Pancreaticoduodenectomy

Summary: This prospective observational 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.

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.
  Over the last 2 years, the investigators have optimized the PG anastomosis in two ways, resulting in even lower POPF rates. First, they have introduced the placement of a plastic stent in the pancreatic duct. Second, they have adapted the invaginated PG anastomosis technique from separate sutures between the pancreatic capsula and the seromuscular layer of the stomach to a new anastomosis technique also called the 'umbrella-technique', i.e. separate trans-pancreatic sutures combined with a running suture between the pancreas and the posterior wall of the stomach. Additionally, the investigators have implemented minimally invasive or laparoscopic surgery with 3D-vision in their pancreatic surgery program, and they have performed over 50 minimally invasive pancreaticoduodenectomies (MIP) over the last 2 years. The situation they are facing now is an extremely low POPF after 3D- MIP with stented pancreaticogastrostomy (sPG), but still with a high rate of DGE (20%) and overall LOS (23 + 1.07; Standard Deviation 9.9).
  The biliary limb of the hepatico-jejunostomy in MIP is anastomosed in-line with the stomach as an iso-peristaltic gastro-enterostomy (Iso-GES). The investigators believe a Roux-en-Y reconstruction of the biliary limb of the hepatico-jejunostomy onto the efferent limb of the gastro-enterostomy (RY-GES) may reduce the length of hospital stay following MIP with sPG.

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

Relevance to patient case: not relevant