Clinical trial NCT04742166: Impact of Side to Side Gastrojejunostomy on the Rate of Delayed Gastric Emptying After Pancreaticoduodenectomy (IPAD)
Official title: Impact of Side to Side Gastrojejunostomy on the Rate of Delayed Gastric Emptying After Pancreaticoduodenectomy: A Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Surgical Technique
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2021-02-05
Enrollment: 166
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Post-operative delayed gastric emptying
timeFrame: Day 90
Secondary outcomes:
measure: Occurrence of Clavien-Dindo complications
timeFrame: Up to day 90
measure: Pancreatic fistula
timeFrame: Up to day 90
measure: Biliary fistula
timeFrame: Up to day 90
measure: Haemorrhage
timeFrame: Up to day 90
measure: Food intake (liquid and solid)
timeFrame: Up to five days after surgery
measure: First gas
timeFrame: Up to five days after surgery
measure: Pre-operative to 3-month post-operative weight ratio
timeFrame: Up to day 90
measure: Albumin and prealbumin levels
timeFrame: Up to day 90
measure: General Quality of Life Score for Digestive Pathologies
timeFrame: Up to day 90
measure: Gastrointestinal Quality of Life Index (GIQLI)
timeFrame: Up to day 90
measure: Mortality rate
timeFrame: Day 30
measure: Mortality rate
timeFrame: Day 90
measure: Time to functional recovery (days) after surgery
timeFrame: Day 90
Other outcomes:
Locations:
city: Marseille
country: France
facility: Institut Paoli Calmettes
city: Rennes
country: France
facility: CHU de Rennes
Study officials:
References: