Pancreatic Cancer ResectableNCT06914349
Antecolic Versus Retrocolic Gastrojejunostomy During Whipple's Procedure
A study testing Antecolic gastrojejunostomy and Retrocolic gastrojejunostomy in people with Pancreatic Cancer Resectable and Pancreas Neoplasms, run by University of Thessaly at 1 site in Greece.
Trial summary
Aim: This randomized clinical study aims to compare occurrence of DGE in patients undergoing either antecolic or retrocolic gastrojejunostomy following pancreaticoduodenectomy. Methods: Participants of this study will be patients undergoing pylorus preserving pancreaticoduodenectomy at the Surgical Department of the… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pancreatic Cancer Resectable, Pancreas Neoplasms
- What is being tested?
- Antecolic gastrojejunostomy and Retrocolic gastrojejunostomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteGreece
- Study dates
- 30 Mar 2025to 31 Mar 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age over 18 years old
- Elective pancreaticoduodenectomy
- Signed consent form
Who cannot join
- Age under 18 years old
- Patients who are participants in other trials that may affect the results of this study
- Patients who do not consent to participate in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Greece1 site, 1 recruiting
- Recruiting
University of Thessaly
Larissa, 41500
Chrysoula-Christina Kolla, 6983075706, christinakolla@yahoo.gr
About this study
Official title: Antecolic Versus Retrocolic Gastrojejunostomy Following Pancreaticoduodenectomy: a Prospective Randomised Study
Aim: This randomized clinical study aims to compare occurrence of DGE in patients undergoing either antecolic or retrocolic gastrojejunostomy following pancreaticoduodenectomy.
Methods: Participants of this study will be patients undergoing pylorus preserving pancreaticoduodenectomy at the Surgical Department of the University Hospital of Larissa. Patients will be randomized to undergo either an antecolic or a retrocolic gastrojejunostomy and the occurrence of DGE will then be compared between the two groups. Individuals younger than 18 or older than 75 years old, as well as patients who do not consent to participate in this trial, will be excluded.
Expected results: Based on available literature, antecolic gastrojejunostomy may be related with a lower incidence of DGE, without a statistically significant difference between the two methods. We aim to show if one of the two methods of gastrointestinal reconstruction (antecolic versus retrocolic) affects DGE.
- Conditions
- Pancreatic Cancer Resectable, Pancreas Neoplasms
- Being tested
- Antecolic gastrojejunostomy, Retrocolic gastrojejunostomy
- Keywords
- Gastrojejunostomy, Whipple's, Antecolic, Retrocolic
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antecolic gastrojejunostomyProcedure or surgery
Gastrojejunostomy in front of the transverse colon
Retrocolic gastrojejunostomyProcedure or surgery
Gastrojejunostomy through the transverse mesocolon
| Study group | Role | What they receive |
|---|---|---|
| Antecolic gastrojejunostomy | Active comparator | Not described Receives: Procedure: Antecolic gastrojejunostomy |
| Retrocolic gastrojejunostomy | Active comparator | Not described Receives: Procedure: Retrocolic gastrojejunostomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delayed Gastric Emptying
The occurence of delayed gastric emptying will be compared between two groups of patients: those who undergo an antecolic gastrojejunostomy and those who undergo a retrocolic approach.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2025
- Study start30 Mar 2025
- Primary completion31 Mar 2028 (estimated)
- Study completion31 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Cancer ResectableStudies of the same condition, open and under way.
- More trials run by University of ThessalyThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Thessaly
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chrysoula-Christina Kolla, University of Thessaly
- Investigators
- Dimitrios Symeonidis, Study chair, University of Thessaly
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06914349
- Sponsor's protocol ID
- University hospital of Larissa
- Status last verified
- Mar 2025
- First submitted
- 30 Mar 2025
- Last updated
- 6 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antecolic Versus Retrocolic Gastrojejunostomy Following Pancreaticoduodenectomy: a Prospective Randomised Study
- ClinicalTrials.gov ID
- NCT06914349
- Acronym / sponsor ID
- University hospital of Larissa
- Conditions
- Pancreatic Cancer Resectable, Pancreas Neoplasms
- Keywords
- Gastrojejunostomy, Whipple's, Antecolic, Retrocolic
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- University of ThessalyUniversity, hospital or other
- Study start
- 30 Mar 2025 (actual)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 31 Mar 2029 (estimated)
- First posted
- 6 Apr 2025 (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.
Aim: This randomized clinical study aims to compare occurrence of DGE in patients undergoing either antecolic or retrocolic gastrojejunostomy following pancreaticoduodenectomy.
Methods: Participants of this study will be patients undergoing pylorus preserving pancreaticoduodenectomy at the Surgical Department of the University Hospital of Larissa. Patients will be randomized to undergo either an antecolic or a retrocolic gastrojejunostomy and the occurrence of DGE will then be compared between the two groups. Individuals younger than 18 or older than 75 years old, as well as patients who do not consent to participate in this trial, will be excluded.
Expected results: Based on available literature, antecolic gastrojejunostomy may be related with a lower incidence of DGE, without a statistically significant difference between the two methods. We aim to show if one of the two methods of gastrointestinal reconstruction (antecolic versus retrocolic) affects DGE.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Antecolic gastrojejunostomy | Active comparator | Procedure: Antecolic gastrojejunostomy |
| Retrocolic gastrojejunostomy | Active comparator | Procedure: Retrocolic gastrojejunostomy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age over 18 years old
- Elective pancreaticoduodenectomy
- Signed consent form
Key exclusion criteria (3 listed)
- Age under 18 years old
- Patients who are participants in other trials that may affect the results of this study
- Patients who do not consent to participate in the study
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 |
|---|---|---|
| Antecolic gastrojejunostomyGastrojejunostomy in front of the transverse colon | Procedure or surgery | Antecolic gastrojejunostomy |
| Retrocolic gastrojejunostomyGastrojejunostomy through the transverse mesocolon | Procedure or surgery | Retrocolic gastrojejunostomy |
Primary outcome
Delayed Gastric Emptying
Time frame: 3 years
The occurence of delayed gastric emptying will be compared between two groups of patients: those who undergo an antecolic gastrojejunostomy and those who undergo a retrocolic approach.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2025.
- Individual participant dataSharing planned: Undecided
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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.
Dimitrios Symeonidis study chair
University of Thessaly
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Antecolic gastrojejunostomy and Retrocolic gastrojejunostomy in people with Pancreatic Cancer Resectable and Pancreas Neoplasms, run by University of Thessaly at 1 site in Greece.
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 3 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: looking for participants now, as of the sponsor's last update on 6 Jun 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 Greece. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chrysoula C Kolla (+306983075706, christinakolla@yahoo.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Delayed Gastric Emptying (time frame: 3 years). 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 6 Jun 2025.