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

Not Applicable

Active, not recruiting

• Conditions: Surgical Technique
• Interventions: Procedure: Reconstruction

• Registration Number: NCT04742166
• Lead Sponsor: Rennes University Hospital

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.

Study Timeline

• Study First Submitted: 2021-02-04
• Study First Submitted QC: 2021-02-04
• Study First Posted: 2021-02-05
• Study Start: 2021-07-07
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-27
• Last Update Posted: 2023-07-28
• Primary Completion: 2024-10-01
• Study Completion: 2024-10-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 166

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Terminolateral gastrojejunal reconstruction	Reconstruction	The post-operative care: usual practise Follow-up: 90 days postoperatively At Day 90: * a blood test for albumin and prealbumin * a GIQLI questionnaire (quality of life score) to be completed by the patient
Side to side gastrojejunal reconstruction	Reconstruction	The post-operative care: usual practise Follow-up: 90 days postoperatively At Day 90: * a blood test for albumin and prealbumin * a GIQLI questionnaire (quality of life score) to be completed by the patient

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Albumin and prealbumin levels	Up to day 90
Biliary fistula	Up to day 90	Occurrence of biliary fistula
Gastrointestinal Quality of Life Index (GIQLI)	Up to day 90
Mortality rate	Day 90
Haemorrhage	Up to day 90	Occurrence of haemorrhage according to the ISGPS classification
Pancreatic fistula	Up to day 90	Occurence of pancreatic fistula (classified according to the ISGPS classification)
First gas	Up to five days after surgery	Time to the emission of the first gas
Pre-operative to 3-month post-operative weight ratio	Up to day 90
Occurrence of Clavien-Dindo complications	Up to day 90
Food intake (liquid and solid)	Up to five days after surgery	Time to oral food intake
General Quality of Life Score for Digestive Pathologies	Up to day 90
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

Trial Locations

Locations (2)

Institut Paoli Calmettes; 🇫🇷 Marseille, France

CHU de Rennes; 🇫🇷 Rennes, France