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

Rennes University Hospital

Status: Active, not recruiting

Conditions: Surgical Technique

Treatments: Procedure: Reconstruction

Study type: Interventional

Funder types: Other

Identifiers

NCT04742166

35RC20_8891_IPAD Study

Details and patient eligibility

About

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

Full 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.

Enrollment: 166 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

166 participants in 2 patient groups

Side to side gastrojejunal reconstruction

Experimental group

Description:

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

Treatment:

Procedure: Reconstruction

Terminolateral gastrojejunal reconstruction

Active Comparator group

Description:

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

Treatment:

Procedure: Reconstruction