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Not yet recruiting NCT07368218

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

No phase Interventional Pancreatic Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Retromesenteric reconstruction, Transmesocolic reconstruction.
Who it may be relevant to
Registry conditions: Pancreatic Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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)

Overview

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.

Interventions

  • Procedure Retromesenteric reconstruction
    Perform a retromesenteric reconstruction after pancreaticoduodenectomy
  • Procedure Transmesocolic reconstruction
    Perform the standard reconstruction procedure (transmesocolic) pancreaticoduodenectomy

Primary outcome measures

  • Delayed Gastric Emptying [Time frame: From first postoperative day to 30 days]
Secondary outcome measures (12)
  • Postoperative morbility [Time frame: Form first postoperative day to day 30]
  • Pancreatic fistula [Time frame: From first postoperative day to day 30]
  • Mortality [Time frame: From first postoperative day to day 90]
  • Hospital stay [Time frame: From first postoperative day to hospital discharge up to 15 weeks]
  • Operative time [Time frame: Periprocedural time, an average time of 300-400 minutes]
  • Proportion of patients with NLR index ≥5 [Time frame: From the first postoperative day to one year follow-up]
  • Proportion of patients with CA19.9 >37 U/ml [Time frame: From the first postoperative day to one year follow-up]
  • Cytokines in serum [Time frame: From the first postoperative day to day 90]
  • Cytokines in abdominal drainage [Time frame: From the first postoperative day to day 90]
  • Cytokines and complications correlation [Time frame: From the first postoperative day to day 90]
  • Recurrence [Time frame: From the first postoperative day to one year follow-up]
  • Time to recurrence [Time frame: From the first postoperative day to one year follow-up]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

Spain · 1 center
  • Hopital Universitari de Bellvitge — L'Hospitalet de Llobregat

Identifiers

NCT: NCT07368218 · HUB-CIR-FAST

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗