Impact of Side to Side Gastrojejunostomy on the Rate of Delayed Gastric Emptying After Pancreaticoduodenectomy (IPAD) (IPAD)
Primary Purpose
Surgical Technique
Status
Active
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Reconstruction
Sponsored by
About this trial
This is an interventional other trial for Surgical Technique
Eligibility Criteria
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.
Sites / Locations
- Institut Paoli Calmettes
- CHU de Rennes
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Side to side gastrojejunal reconstruction
Terminolateral gastrojejunal reconstruction
Arm 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
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
Outcomes
Primary Outcome Measures
Post-operative delayed gastric emptying
Occurrence of post-operative delayed gastric emptying (classified to the International Study Group for Pancreatic Surgery (ISGPS))
Secondary Outcome Measures
Occurrence of Clavien-Dindo complications
Pancreatic fistula
Occurence of pancreatic fistula (classified according to the ISGPS classification)
Biliary fistula
Occurrence of biliary fistula
Haemorrhage
Occurrence of haemorrhage according to the ISGPS classification
Food intake (liquid and solid)
Time to oral food intake
First gas
Time to the emission of the first gas
Pre-operative to 3-month post-operative weight ratio
Albumin and prealbumin levels
General Quality of Life Score for Digestive Pathologies
Gastrointestinal Quality of Life Index (GIQLI)
Mortality rate
Mortality rate
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
Full Information
NCT ID
NCT04742166
First Posted
February 4, 2021
Last Updated
July 27, 2023
Sponsor
Rennes University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04742166
Brief Title
Impact of Side to Side Gastrojejunostomy on the Rate of Delayed Gastric Emptying After Pancreaticoduodenectomy (IPAD)
Acronym
IPAD
Official Title
Impact of Side to Side Gastrojejunostomy on the Rate of Delayed Gastric Emptying After Pancreaticoduodenectomy: A Prospective Randomized Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 7, 2021 (Actual)
Primary Completion Date
October 1, 2024 (Anticipated)
Study Completion Date
October 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rennes University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Technique
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
166 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Side to side gastrojejunal reconstruction
Arm Type
Experimental
Arm 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
Arm Title
Terminolateral gastrojejunal reconstruction
Arm Type
Active Comparator
Arm 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
Intervention Type
Procedure
Intervention Name(s)
Reconstruction
Intervention Description
Lateral gastrojejunal Terminolateral gastrojejunal
Primary Outcome Measure Information:
Title
Post-operative delayed gastric emptying
Description
Occurrence of post-operative delayed gastric emptying (classified to the International Study Group for Pancreatic Surgery (ISGPS))
Time Frame
Day 90
Secondary Outcome Measure Information:
Title
Occurrence of Clavien-Dindo complications
Time Frame
Up to day 90
Title
Pancreatic fistula
Description
Occurence of pancreatic fistula (classified according to the ISGPS classification)
Time Frame
Up to day 90
Title
Biliary fistula
Description
Occurrence of biliary fistula
Time Frame
Up to day 90
Title
Haemorrhage
Description
Occurrence of haemorrhage according to the ISGPS classification
Time Frame
Up to day 90
Title
Food intake (liquid and solid)
Description
Time to oral food intake
Time Frame
Up to five days after surgery
Title
First gas
Description
Time to the emission of the first gas
Time Frame
Up to five days after surgery
Title
Pre-operative to 3-month post-operative weight ratio
Time Frame
Up to day 90
Title
Albumin and prealbumin levels
Time Frame
Up to day 90
Title
General Quality of Life Score for Digestive Pathologies
Time Frame
Up to day 90
Title
Gastrointestinal Quality of Life Index (GIQLI)
Time Frame
Up to day 90
Title
Mortality rate
Time Frame
Day 30
Title
Mortality rate
Time Frame
Day 90
Title
Time to functional recovery (days) after surgery
Description
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
Time Frame
Day 90
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Institut Paoli Calmettes
City
Marseille
ZIP/Postal Code
13009
Country
France
Facility Name
CHU de Rennes
City
Rennes
ZIP/Postal Code
35033
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Impact of Side to Side Gastrojejunostomy on the Rate of Delayed Gastric Emptying After Pancreaticoduodenectomy (IPAD)
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