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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04742166
Other study ID # 35RC20_8891_IPAD Study
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date July 7, 2021
Est. completion date October 1, 2024

Study information

Verified date July 2023
Source Rennes University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 166
Est. completion date October 1, 2024
Est. primary completion date October 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Reconstruction
Lateral gastrojejunal Terminolateral gastrojejunal

Locations

Country Name City State
France Institut Paoli Calmettes Marseille
France CHU de Rennes Rennes

Sponsors (1)

Lead Sponsor Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Post-operative delayed gastric emptying Occurrence of post-operative delayed gastric emptying (classified to the International Study Group for Pancreatic Surgery (ISGPS)) Day 90
Secondary Occurrence of Clavien-Dindo complications Up to day 90
Secondary Pancreatic fistula Occurence of pancreatic fistula (classified according to the ISGPS classification) Up to day 90
Secondary Biliary fistula Occurrence of biliary fistula Up to day 90
Secondary Haemorrhage Occurrence of haemorrhage according to the ISGPS classification Up to day 90
Secondary Food intake (liquid and solid) Time to oral food intake Up to five days after surgery
Secondary First gas Time to the emission of the first gas Up to five days after surgery
Secondary Pre-operative to 3-month post-operative weight ratio Up to day 90
Secondary Albumin and prealbumin levels Up to day 90
Secondary General Quality of Life Score for Digestive Pathologies Up to day 90
Secondary Gastrointestinal Quality of Life Index (GIQLI) Up to day 90
Secondary Mortality rate Day 30
Secondary Mortality rate Day 90
Secondary 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
Day 90
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