Prospective bi-centric randomized open-label study comparing side to side and end to side gastrojejunostomy in pancreaticoduodenectomy
Delayed gastric emptying is one of the main complications occurring after pancreatodudodenectomy, the incidence of which is estimated between 10 and 40% in the literature. Its occurrence leads to an alteration in post-operative quality of life (maintenance or resting of the nasogastric tube) and is the primary reason an increase in the length of hospital stay and therefore the cost of treatment. In addition, it predisposes to the risk of inhalation pneumopathy, which increases the risk of post-operative death. Various technical surgical points have been suggested by retrospective studies to reduce its incidence (pyloric preservation, respect for the left gastric vein, ante-colic positioning of the Child's handle, making a Y-shaped handle) but without ever being validated in randomized prospective studies. Recently three retrospective studies have highlighted the interest of performing a side to side l rather than an end to side gastro-jejunal anastomosis to reduce the rate of post-operative delayed gastric emptying.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
166
Lateral gastrojejunal Terminolateral gastrojejunal
Institut Paoli Calmettes
Marseille, France
CHU de Rennes
Rennes, France
Post-operative delayed gastric emptying
Occurrence of post-operative delayed gastric emptying (classified to the International Study Group for Pancreatic Surgery (ISGPS))
Time frame: Day 90
Occurrence of Clavien-Dindo complications
Time frame: Up to day 90
Pancreatic fistula
Occurence of pancreatic fistula (classified according to the ISGPS classification)
Time frame: Up to day 90
Biliary fistula
Occurrence of biliary fistula
Time frame: Up to day 90
Haemorrhage
Occurrence of haemorrhage according to the ISGPS classification
Time frame: Up to day 90
Food intake (liquid and solid)
Time to oral food intake
Time frame: Up to five days after surgery
First gas
Time to the emission of the first gas
Time frame: Up to five days after surgery
Pre-operative to 3-month post-operative weight ratio
Time frame: Up to day 90
Albumin and prealbumin levels
Time frame: Up to day 90
General Quality of Life Score for Digestive Pathologies
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Time frame: Up to day 90
Gastrointestinal Quality of Life Index (GIQLI)
Time frame: Up to day 90
Mortality rate
Time frame: Day 30
Mortality rate
Time frame: Day 90
Time to functional recovery (days) after surgery
Functional recovery defined as all of the following: * independently mobile at the preoperative level * sufficient pain control with oral medication alone * ability to maintain at least 50% daily required caloric intake * no intravenous fluid administration * no clinical signs of infection when other criteria were met
Time frame: Day 90