Duodenal DiverticulizationTRAUMADUODNCT06058975
National Retrospective Study of Duodenal Trauma
An observational study of Duodenal Diverticulization and Pyloric Exclusion, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
Duodenal injuries remain rare among abdominal trauma, concerning less than 5 % of cases. However, due to its central location, it is most commonly associated with multiple organs lesions, with the main three organs being the liver, the colon and the pancreas. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Duodenal Diverticulization, Pyloric Exclusion, Gastrojejunostomy
- What is being tested?
- Observational
- How many people
- 135 participants
- Where
- 1 siteFrance
- Study dates
- 8 Jan 2023to 31 Dec 2024
- Phase
- Observational
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient with duodenal trauma
Who may be able to join
- patients with duodenal trauma,
- older than 18 years old.
Who cannot join
- pregnancy
- previous duodenal surgery.
- Associated surrounding organs trauma, was not an exclusion criterion, but duodenal trauma must have been one of the main injuries.
Trial locations and contacts
1 site in 1 country.
About this study
Duodenal injuries remain rare among abdominal trauma, concerning less than 5 % of cases. However, due to its central location, it is most commonly associated with multiple organs lesions, with the main three organs being the liver, the colon and the pancreas. Additionally, the penetrating mechanism is four times more common than blunt trauma and the most common duodenal site of injury is the second portion (36 %), the least being the first duodenum (13 %). These particularities generate a high morbidity, ranging from 22 to 27.1 %, and a mortality still as high as 5.3 to 30 % today. When facing it, surgeons are usually challenged in their strategy. Indeed, when surgery is required, different options can be chosen depending on the grade of the lesion and the involvement of the papilla and/or other organs. Primary repairs, duodenal diverticulization, pyloric exclusion, gastrojejunostomy, retrograde duodenostomy, distal feeding tube, or even resection and Whipple procedures, have all been described. Since the classification of the American Association for the surgery of trauma (AAST), most studies stratified their management as such: drainage only or primary repair for grade 1 and 2, jejunostomy and/or pyloric exclusion for grade 3, Whipple for grade 4 or 5. However, reviews of the literature aren't clear if this decisional tree is in correlation with lower morbidities, and often different procedures have been reported for the same grade. The escalation of technical exclusions among severe grades became controversial. As an example, pyloric exclusion has been criticized in its preventive role of protecting the suture, being useless at least, or even worse at times. Thus, in the recent years, the management has been focused towards minimization. Indeed, in the retrospective review of the Pan-American trauma society primary repair alone was performed in 80 % of cases, all grades comprised. Although mortality was high, duodenal suture line leak was statistically lower among survivors over every grade.
To clear the situation, prospective studies are difficult if not impossible in such context. Thus, The investigators propose this national benchmark, to retrospectively review in France the management of duodenal trauma, depending on the grade, and its associated morbidity.
- Conditions
- Duodenal Diverticulization, Pyloric Exclusion, Gastrojejunostomy, Retrograde Duodenostomy, Distal Feeding Tube, Resection and Whipple Procedures
- Being tested
- Observational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationalOther
Review the management of duodenal trauma in France
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall mortality
Study mortality is overall mortality, not specific to abdominal trauma. It corresponds to grade 5 of the Clavien-Dindo classification.
Measured: 1 month after trauma
Specific mortality
Specific mortality is the mortality due to abdominal trauma, including abdominal compartment syndrome, coagulopathy, hemorrhage, multi-organ failure, etc. It excludes brain death, mortality due to trauma of other body regions. It corresponds to grade 5 of the Clavien-Dindo classification.
Measured: 1 month after trauma
Secondary outcomes (3)
Severe morbidity
Morbidity will be recorded according to the Clavien-Dindo classification. We will study overall morbidity and severe morbidity (stages 3 and 4). As a reminder, stage 1 corresponds to a simple deviation from the operative course, stage 2 to medical treatment, stage 3 to interventional management (with or without general anaesthesia), and stage 4 to organ or multi-visceral failure.
Measured: 3 months after trauma
Kind of treatment: medical, endoscopic or surgical
We will record the type of initial treatment performed, whether non-operative, endoscopic, laparoscopic or by laparotomy.
We will collect the results of this initial treatment, including the possibility of complementary treatments, whatever the approach used and any failures.
Non-operative management is defined as an exclusive medical attitude, including diagnostic imaging, but without interventional procedures.
Interventional radiology management is defined as a percutaneous procedure performed under the control of diagnostic imaging, e.g. ultrasound- or scan-guided puncture of a collection.
Endoscopic management includes diagnostic or therapeutic endoscopy, for example: endoscopic realignment of the Wirsung duct, puncture of a pancreatic pseudocyst, duodenal stenting, etc.
Surgical management is defined as any surgical procedure requiring an opening of the abdomen. The approach is indicated as laparotomy or laparoscopy.
Measured: The first 3 months after trauma
type of injury of the duodenum
The surgeon is free to describe the lesions, in order to gather as much information as possible on the location of the lesion, its size, etc.
We will also ask investigators to describe the lesions encountered, using the classification established by the AAST (American Association for the Surgery of Trauma).
Measured: no later than the 7th day after the trauma
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start8 Jan 2023
- Primary completion30 Sep 2023
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Duodenal DiverticulizationStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06058975
- Sponsor's protocol ID
- 23Urgences02
- Acronym
- TRAUMADUOD
- Status last verified
- Sep 2023
- First submitted
- 30 Aug 2023
- Last updated
- 2 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Frey S, Bentellis I, Gaujoux S, Girard E, Abba J, Chirica M, Bertrand M, Boutry E, Mege D, Aubert M, Alves A, Hornez E, Mulliri A, Brustia R, Hentati H, Lauka L, Laurent A, Sommacale D, Turco C, Dezeustre M, Bajul M, Castel A, Facy O, Grellet R, Sulpice L, Menegaux F, Delestre M, Lermite E, Monchal T, Amrou R, Bacoeur-Ouzillou O, Pezet D, Bonnet J, Buc E, Passot G, Schneck AS, Birnbaum DJ, Blanc PY, Le Roy B, Monneuse O, Rodriguez Q, Suc B, Baque P, Dubuisson V, Massalou D. How are duodenal trauma managed? A French nationwide study. World J Emerg Surg. 2025 Dec 9;20(1):89. doi: 10.1186/s13017-025-00661-z.
PubMed 41366408
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National Retrospective Study of Duodenal Trauma
- ClinicalTrials.gov ID
- NCT06058975
- Acronym / sponsor ID
- TRAUMADUOD / 23Urgences02
- Conditions
- Duodenal Diverticulization, Pyloric Exclusion, Gastrojejunostomy, Retrograde Duodenostomy, Distal Feeding Tube, Resection and Whipple Procedures
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 8 Jan 2023 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 28 Sep 2023 (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.
Duodenal injuries remain rare among abdominal trauma, concerning less than 5 % of cases. However, due to its central location, it is most commonly associated with multiple organs lesions, with the main three organs being the liver, the colon and the pancreas. Additionally, the penetrating mechanism is four times more common than blunt trauma and the most common duodenal site of injury is the second portion (36 %), the least being the first duodenum (13 %). These particularities generate a high morbidity, ranging from 22 to 27.1 %, and a mortality still as high as 5.3 to 30 % today. When facing it, surgeons are usually challenged in their strategy. Indeed, when surgery is required, different options can be chosen depending on the grade of the lesion and the involvement of the papilla and/or other organs. Primary repairs, duodenal diverticulization, pyloric exclusion, gastrojejunostomy, retrograde duodenostomy, distal feeding tube, or even resection and Whipple procedures, have all been described. Since the classification of the American Association for the surgery of trauma (AAST), most studies stratified their management as such: drainage only or primary repair for grade 1 and 2, jejunostomy and/or pyloric exclusion for grade 3, Whipple for grade 4 or 5. However, reviews of the literature aren't clear if this decisional tree is in correlation with lower morbidities, and often different procedures have been reported for the same grade. The escalation of technical exclusions among severe grades became controversial. As an example, pyloric exclusion has been criticized in its preventive role of protecting the suture, being useless at least, or even worse at times. Thus, in the recent years, the management has been focused towards minimization. Indeed, in the retrospective review of the Pan-American trauma society primary repair alone was performed in 80 % of cases, all grades comprised. Although mortality was high, duodenal suture line leak was statistically lower among survivors over every grade.
To clear the situation, prospective studies are difficult if not impossible in such context. Thus, The investigators propose this national benchmark, to retrospectively review in France the management of duodenal trauma, depending on the grade, and its associated morbidity.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with duodenal trauma
Key inclusion criteria (2 listed)
- patients with duodenal trauma,
- older than 18 years old.
Key exclusion criteria (3 listed)
- pregnancy
- previous duodenal surgery.
- Associated surrounding organs trauma, was not an exclusion criterion, but duodenal trauma must have been one of the main injuries.
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 |
|---|---|---|
| ObservationalReview the management of duodenal trauma in France | Other | – |
Primary outcome
Overall mortality
Time frame: 1 month after trauma
Study mortality is overall mortality, not specific to abdominal trauma. It corresponds to grade 5 of the Clavien-Dindo classification.
Specific mortality
Time frame: 1 month after trauma
Specific mortality is the mortality due to abdominal trauma, including abdominal compartment syndrome, coagulopathy, hemorrhage, multi-organ failure, etc. It excludes brain death, mortality due to trauma of other body regions. It corresponds to grade 5 of the Clavien-Dindo classification.
3 secondary outcomes
Severe morbidity
Time frame: 3 months after trauma
Kind of treatment: medical, endoscopic or surgical
Time frame: The first 3 months after trauma
type of injury of the duodenum
Time frame: no later than the 7th day after the trauma
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2025.
- Derived from this study: PubMed 41366408Frey S, Bentellis I, Gaujoux S, Girard E, Abba J, Chirica M, Bertrand M, Boutry E, Mege D, Aubert M, Alves A, Hornez E, Mulliri A, Brustia R, Hentati H, Lauka L, Laurent A, Sommacale D, Turco C, Dezeustre M, Bajul M, Castel A, Facy O, Grellet R, Sulpice L, Menegaux F, Delestre M, Lermite E, Monchal T, Amrou R, Bacoeur-Ouzillou O, Pezet D, Bonnet J, Buc E, Passot G, Schneck AS, Birnbaum DJ, Blanc PY, Le Roy B, Monneuse O, Rodriguez Q, Suc B, Baque P, Dubuisson V, Massalou D. How are duodenal trauma managed? A French nationwide study. World J Emerg Surg. 2025 Dec 9;20(1):89. doi: 10.1186/s13017-025-00661-z.
- Individual participant dataSharing planned: No
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Duodenal Diverticulization and Pyloric Exclusion, run by Centre Hospitalier Universitaire de Nice at 1 site 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 2 inclusion and 3 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: finished, as of the sponsor's last update on 2 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Overall mortality (time frame: 1 month after trauma). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06058975, which also lists 1 linked publication.
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 2 Apr 2025.