Impact of Side to Side Gastrojejunostomy on the Rate of Delayed Gastric Emptying After Pancreaticoduodenectomy (IPAD)

  • STATUS
    Recruiting
  • End date
    Jul 1, 2023
  • participants needed
    166
  • sponsor
    Rennes University Hospital
Updated on 23 August 2021

Summary

Prospective bi-centric randomized open-label study comparing side to side and end to side gastrojejunostomy in pancreaticoduodenectomy

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.

Details
Condition Surgical Technique
Treatment Reconstruction, Reconstruction
Clinical Study IdentifierNCT04742166
SponsorRennes University Hospital
Last Modified on23 August 2021

Eligibility

Yes No Not Sure

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
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