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

Surgical Technique Clinical Trial

— IPAD  

Official title:

Impact of Side to Side Gastrojejunostomy on the Rate of Delayed Gastric Emptying After Pancreaticoduodenectomy: A Prospective Randomized Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04742166
• Other study ID #: 35RC20_8891_IPAD Study
• Status: Active, not recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Gastroparesis
• Surgical Technique

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