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NCT Number: NCT07368218

Comparison of 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.

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Key information

Conditions

Pancreatic Cancer Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Gastrointestinal Diseases Gastroparesis Neoplasms Neoplasms by Site Neurologic Manifestations Pancreatic Diseases Pancreatic Neoplasms Paralysis Pathological Conditions, Signs and Symptoms Signs and Symptoms Stomach Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hopital Universitari de Bellvitge

L'Hospitalet de Llobregat, Spain, 08907

Location contact

Juli Busquets Barenys, Md, PhD

CONTACT

[email protected]

93 260 75 00

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Retromesenteric reconstruction

Procedure

Perform a retromesenteric reconstruction after pancreaticoduodenectomy

Transmesocolic reconstruction

Procedure

Perform the standard reconstruction procedure (transmesocolic) pancreaticoduodenectomy

Primary outcomes

  1. Delayed Gastric Emptying

    Time frame: From first postoperative day to 30 days

    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)

Secondary outcomes

  1. Postoperative morbility

    Time frame: Form first postoperative day to day 30

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

  2. Pancreatic fistula

    Time frame: From first postoperative day to day 30

    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)

  3. Mortality

    Time frame: From first postoperative day to day 90

    30- and 90-day mortality (any cause)

  4. Hospital stay

    Time frame: From first postoperative day to hospital discharge up to 15 weeks

    Postoperative hospital stay days (from surgery to hospital discharge)

  5. Operative time

    Time frame: Periprocedural time, an average time of 300-400 minutes

    Total operative time (minutes)

  6. Proportion of patients with NLR index ≥5

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

    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.

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

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

    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.

  8. Cytokines in serum

    Time frame: From the first postoperative day to day 90

    • 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

  9. Cytokines in abdominal drainage

    Time frame: From the first postoperative day to day 90

    • 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

  10. Cytokines and complications correlation

    Time frame: From the first postoperative day to day 90

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

  11. Recurrence

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

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

  12. Time to recurrence

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

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

  13. Complications-recurrence correlation

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

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

Study contacts

Contact information is provided by the study sponsor or research team.

Juli Busquets Barenys, Md, PhD

CONTACT

[email protected]

93 260 75 00

Sponsors and collaborators

Lead sponsor

Hospital Universitari de Bellvitge

Other

Registry information

Official study 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)

Acronym: FAST

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jan 26, 2026
Registry last updated
Jan 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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