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

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Surgical Technique
• Intervention / Treatment: Procedure: Reconstruction

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 Type: Interventional
• Enrollment (Estimated): 166
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fabien ROBIN, MD; Phone Number: 02 99 28 69 89; Email: fabien.robin@chu-rennes.fr
• Study Contact Backup: Name: Laurent SULPICE, MD, PhD; Email: laurent.sulpice@chu-rennes.fr

Study Locations

• France
  • Marseille, France, 13009
    • Institut Paoli Calmettes
  • Rennes, France, 35033
    • Chu de Rennes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Side to side gastrojejunal 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	Procedure: Reconstruction; Lateral gastrojejunal Terminolateral gastrojejunal
Active Comparator: Terminolateral gastrojejunal 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	Procedure: Reconstruction; Lateral gastrojejunal Terminolateral gastrojejunal

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Rennes University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 7, 2021
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): October 1, 2024

Study Registration Dates

• First Submitted: February 4, 2021
• First Submitted That Met QC Criteria: February 4, 2021
• First Posted (Actual): February 5, 2021

Study Record Updates

• Last Update Posted (Actual): July 28, 2023
• Last Update Submitted That Met QC Criteria: July 27, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neurologic Manifestations; Gastrointestinal Diseases; Stomach Diseases; Paralysis; Gastroparesis
• Other Study ID Numbers: 35RC20_8891_IPAD Study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No