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Pancreatic CancerFASTNCT07368218

Comparison of Transmesocolic Versus Retromesenteric Reconstruction in Cephalic Duodenopancreatectomy (FAST Trial)

A study testing Retromesenteric reconstruction and Transmesocolic reconstruction in people with Pancreatic Cancer, run by Hospital Universitari de Bellvitge at 1 site in Spain.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

Objective: To compare the incidence of delayed gastric emptying (ISGPS 2007 criteria) between patients undergoing retromesenteric versus transmesocolic reconstruction after pancreaticoduodenectomy. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pancreatic Cancer
What is being tested?
Retromesenteric reconstruction and Transmesocolic reconstruction
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
124 participants
Where
1 siteSpain
Study dates
31 Jan 2026to Jun 2028
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18 years
  • Candidates for cephalic duodenopancreatectomy due to pancreatic pathology
  • Ability to complete follow-up questionnaires

Who cannot join

  • Emergency surgery
  • Participation in another clinical trial
  • Pregnancy or lactation
  • Severe psychiatric disorder that prevents follow-up
  • Inability to understand the information and sign study consent

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Juli Busquets Barenys, Md, PhD contact

93 260 75 00

jbusquets@bellvitgehospital.cat

Spain1 site

  • Hopital Universitari de Bellvitge

    L'Hospitalet de Llobregat, Spain, 08907

    Juli Busquets Barenys, Md, PhD, 93 260 75 00, jbusquets@bellvitgehospital.cat

Other trials in Spain

About this study

Official title: Randomized Clinical Trial on Morbidity, Psychological Impact, and Changes in Biomarker Concentration During the Perioperative Period Comparing Transmesocolic Versus Retromesenteric Reconstruction in Cephalic Duodenopancreatectomy (FAST Trial)

Objective: To compare the incidence of delayed gastric emptying (ISGPS 2007 criteria) between patients undergoing retromesenteric versus transmesocolic reconstruction after pancreaticoduodenectomy. Secondary objectives include evaluating overall postoperative morbidity (Clavien-Dindo ≥ Grade I) at 90 days, postoperative pancreatic fistula according to ISGPF criteria, 30- and 90-day mortality, differences in operative time and blood loss, hospital stay duration, exploratory analysis of inflammatory biomarkers in serum and drainage fluid, psychological impact using SCL-90-R scale, and postoperative quality of life using EORTC QLQ-C30 scale.

Methods: Randomized, controlled, single-center superiority clinical trial with 1:1 allocation. One hundred twenty-four patients candidates for duodenopancreatectomy due to pancreatic pathology will be randomized using balanced blocks to transmesocolic (control) or retromesenteric (study) reconstruction. Randomization will be revealed after completing the resection phase. Primary intention-to-treat analysis will estimate relative risk with 95% CI for dichotomous variables, Kaplan-Meier survival analysis with log-rank test, and linear mixed models for repeated measures in quality of life outcomes. Follow-up will be 90 days for the primary endpoint, extending to 12 months for secondary objectives.

Being tested
Retromesenteric reconstruction, Transmesocolic reconstruction
Keywords
duodenopancreatectomy, Pancreatic cancer, Delayed Gastric emptying
Medical subject headings
Pancreatic Neoplasms, Gastroparesis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Retromesenteric reconstructionProcedure or surgery

    Perform a retromesenteric reconstruction after pancreaticoduodenectomy

  • Transmesocolic reconstructionProcedure or surgery

    Perform the standard reconstruction procedure (transmesocolic) pancreaticoduodenectomy

Study groups in NCT07368218
Study groupRoleWhat they receive
Retromesenteric reconstructionExperimentalNot described
Receives: Procedure: Retromesenteric reconstruction
Transmesocolic reconstructionActive comparatorNot described
Receives: Procedure: Transmesocolic reconstruction

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Delayed Gastric Emptying

    Delayed gastric emptying according to ISGPS 2007 definition: Grade A (nasogastric tube >3 days or reinsertion between days 4-7 + vomiting); Grade B (tube >7 days or reinsertion after day 7 + vomiting); Grade C (impossibility of oral tolerance after day 14)

    Measured: From first postoperative day to 30 days

Secondary outcomes (13)

  1. Postoperative morbility

    Postoperative morbidity at 90 days according to Clavien-Dindo classification (≥ Grade I)

    Measured: Form first postoperative day to day 30

  2. Pancreatic fistula

    Pancreatic fistula according to ISGPF 2016 definition: Grade A (drainage amylase >3x normal on day 3 without clinical impact); Grade B (requiring management change); Grade C (reintervention or death)

    Measured: From first postoperative day to day 30

  3. Mortality

    30- and 90-day mortality (any cause)

    Measured: From first postoperative day to day 90

  4. Hospital stay

    Postoperative hospital stay days (from surgery to hospital discharge)

    Measured: From first postoperative day to hospital discharge up to 15 weeks

  5. Operative time

    Total operative time (minutes)

    Measured: Periprocedural time, an average time of 300-400 minutes

  6. Proportion of patients with NLR index ≥5

    First, a preoperative NLR index determination from the preoperative blood count.

    Proportion of patients with NLR cut-off point ≥5, which is associated with lower overall survival and recurrence-free survival in patients undergoing pancreatic resection.

    Measured: From the first postoperative day to one year follow-up

  7. Proportion of patients with CA19.9 >37 U/ml

    First, a preoperative CA19.9 measurement from preoperative laboratory tests. Determination of the proportion of patients with CA 19.9 cut-off point >37 U/ml, as it is considered elevated according to the standard reference range.

    Measured: From the first postoperative day to one year follow-up

  8. Cytokines in serum

    • Cytokine concentration in serum: continuous variable measured at 24 hours and day 5 post-surgery in a subsample of 30 patients.
    • Detection panel: 2000 inflammatory biomarkers using high-sensitivity semi-quantitative Raybiotech L-series arrays with densitometric reading

    Measured: From the first postoperative day to day 90

  9. Cytokines in abdominal drainage

    • Cytokine concentration in drainage fluid: continuous variable measured at 24 hours and day 5 post-surgery in a subsample of 30 patients.
    • Detection panel: 2000 inflammatory biomarkers using high-sensitivity semi-quantitative Raybiotech L-series arrays with densitometric reading

    Measured: From the first postoperative day to day 90

  10. Cytokines and complications correlation

    Exploratory analysis of the association between cytokine levels and the appearance of complications during the first 90 days.

    Measured: From the first postoperative day to day 90

  11. Recurrence

    • Recurrence of malignant pathology: Defined as the appearance of local, regional, or distant disease documented by imaging techniques (CT/MRI) or histopathological confirmation.

    Measured: From the first postoperative day to one year follow-up

  12. Time to recurrence

    • Time to recurrence: Time elapsed from surgery to detection of recurrence (months).

    Measured: From the first postoperative day to one year follow-up

  13. Complications-recurrence correlation

    Association analysis between the presence of complications (Clavien-Dindo ≥ II) and early recurrence (≤12 months).

    Measured: From the first postoperative day to one year follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jan 2026
  2. Study start31 Jan 2026 (estimated)
  3. Primary completionJun 2027 (estimated)
  4. Study completionJun 2028 (estimated)

Resources

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
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
124 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07368218
Sponsor's protocol ID
HUB-CIR-FAST
Acronym
FAST
Status last verified
Jan 2026
First submitted
11 Jan 2026
Last updated
26 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Retromesenteric reconstruction and Transmesocolic reconstruction in people with Pancreatic Cancer, run by Hospital Universitari de Bellvitge at 1 site in Spain.

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 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: opening soon, as of the sponsor's last update on 26 Jan 2026. 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 Spain. 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 Juli Busquets Barenys, Md, PhD (93 260 75 00, jbusquets@bellvitgehospital.cat), 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: From first postoperative day to 30 days). 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 NCT07368218.

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 26 Jan 2026.

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