Surgical Technique
Conditions
Brief summary
Prospective bi-centric randomized open-label study comparing side to side and end to side gastrojejunostomy in pancreaticoduodenectomy
Detailed description
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.
Interventions
PROCEDUREReconstruction
Lateral gastrojejunal Terminolateral gastrojejunal
Sponsors
Rennes University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* patient over 18 years old * to benefit from a cephalic duodenopancreatectomy whatever the indication (benign and malignant tumor) * affiliated with a health insurance system * having received oral and written information about the protocol and having signed a free and informed written consent.
Exclusion criteria
* associated organ resection except for portal vein or hepatic artery resection. * history of gastric or esophageal resection * person subject to legal protection (safeguard justice, trusteeship and guardianship) and persons deprived of liberty * pregnant or breastfeeding women * patient participating in another clinical trial that may interfere with the protocol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative delayed gastric emptying | Day 90 | Occurrence of post-operative delayed gastric emptying (classified to the International Study Group for Pancreatic Surgery (ISGPS)) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pancreatic fistula | Up to day 90 | Occurence of pancreatic fistula (classified according to the ISGPS classification) |
| Biliary fistula | Up to day 90 | Occurrence of biliary fistula |
| Haemorrhage | Up to day 90 | Occurrence of haemorrhage according to the ISGPS classification |
| Food intake (liquid and solid) | Up to five days after surgery | Time to oral food intake |
| First gas | Up to five days after surgery | Time to the emission of the first gas |
| Occurrence of Clavien-Dindo complications | Up to day 90 | — |
| Albumin and prealbumin levels | Up to day 90 | — |
| General Quality of Life Score for Digestive Pathologies | Up to day 90 | — |
| Gastrointestinal Quality of Life Index (GIQLI) | Up to day 90 | — |
| Mortality rate | Day 30 | — |
| Time to functional recovery (days) after surgery | Day 90 | 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 |
| Pre-operative to 3-month post-operative weight ratio | Up to day 90 | — |
Countries
France
Outcome results
None listed