Surgical TechniqueIPADNCT04742166
Impact of Side to Side Gastrojejunostomy on the Rate of Delayed Gastric Emptying After Pancreaticoduodenectomy (IPAD)
A study testing Reconstruction in people with Surgical Technique, run by Rennes University Hospital at 2 sites in France.
Trial summary
Prospective bi-centric randomized open-label study comparing side to side and end to side gastrojejunostomy in pancreaticoduodenectomy Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgical Technique
- What is being tested?
- Reconstruction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 166 participants
- Where
- 2 sitesFrance
- Study dates
- 7 Jul 2021to 1 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
France2 sites
Institut Paoli Calmettes
Marseille, 13009
CHU de Rennes
Rennes, 35033
About this study
Official title: 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
Read the 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.
- Conditions
- Surgical Technique
- Being tested
- Reconstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReconstructionProcedure or surgery
Lateral gastrojejunal Terminolateral gastrojejunal
| Study group | Role | What they receive |
|---|---|---|
| Side to side gastrojejunal reconstruction | Experimental | 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 Receives: Procedure: Reconstruction |
| Terminolateral gastrojejunal reconstruction | Active comparator | 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 Receives: Procedure: Reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative delayed gastric emptying
Occurrence of post-operative delayed gastric emptying (classified to the International Study Group for Pancreatic Surgery (ISGPS))
Measured: Day 90
Secondary outcomes (13)
Occurrence of Clavien-Dindo complications
Measured: Up to day 90
Pancreatic fistula
Occurence of pancreatic fistula (classified according to the ISGPS classification)
Measured: Up to day 90
Biliary fistula
Occurrence of biliary fistula
Measured: Up to day 90
Haemorrhage
Occurrence of haemorrhage according to the ISGPS classification
Measured: Up to day 90
Food intake (liquid and solid)
Time to oral food intake
Measured: Up to five days after surgery
First gas
Time to the emission of the first gas
Measured: Up to five days after surgery
Pre-operative to 3-month post-operative weight ratio
Measured: Up to day 90
Albumin and prealbumin levels
Measured: Up to day 90
General Quality of Life Score for Digestive Pathologies
Measured: Up to day 90
Gastrointestinal Quality of Life Index (GIQLI)
Measured: Up to day 90
Mortality rate
Measured: Day 30
Mortality rate
Measured: Day 90
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
Measured: Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2021
- Study start7 Jul 2021
- Primary completion1 Oct 2024 (estimated)
- Study completion1 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical TechniqueStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 166 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04742166
- Sponsor's protocol ID
- 35RC20_8891_IPAD Study
- Acronym
- IPAD
- Status last verified
- Jul 2023
- First submitted
- 4 Feb 2021
- Last updated
- 28 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Side to Side Gastrojejunostomy on the Rate of Delayed Gastric Emptying After Pancreaticoduodenectomy: A Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT04742166
- Acronym / sponsor ID
- IPAD / 35RC20_8891_IPAD Study
- Conditions
- Surgical Technique
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 166 participants (estimated)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 7 Jul 2021 (actual)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 1 Oct 2024 (estimated)
- First posted
- 5 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Side to side gastrojejunal reconstruction | Experimental | Procedure: ReconstructionThe 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 |
| Terminolateral gastrojejunal reconstruction | Active comparator | Procedure: ReconstructionThe 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ReconstructionLateral gastrojejunal Terminolateral gastrojejunal | Procedure or surgery | Side to side gastrojejunal reconstruction, Terminolateral gastrojejunal reconstruction |
Primary outcome
Post-operative delayed gastric emptying
Time frame: Day 90
Occurrence of post-operative delayed gastric emptying (classified to the International Study Group for Pancreatic Surgery (ISGPS))
13 secondary outcomes
Occurrence of Clavien-Dindo complications
Time frame: Up to day 90
Pancreatic fistula
Time frame: Up to day 90
Biliary fistula
Time frame: Up to day 90
Haemorrhage
Time frame: Up to day 90
Food intake (liquid and solid)
Time frame: Up to five days after surgery
First gas
Time frame: Up to five days after surgery
Pre-operative to 3-month post-operative weight ratio
Time frame: Up to day 90
Albumin and prealbumin levels
Time frame: Up to day 90
General Quality of Life Score for Digestive Pathologies
Time frame: Up to day 90
Gastrointestinal Quality of Life Index (GIQLI)
Time frame: Up to day 90
Mortality rate
Time frame: Day 30
Mortality rate
Time frame: Day 90
Time to functional recovery (days) after surgery
Time frame: Day 90
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reconstruction in people with Surgical Technique, run by Rennes University Hospital at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-operative delayed gastric emptying (time frame: Day 90). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2023.