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

January 18, 2026 updated by: BUSQUETS, JULI, Hospital Universitari de Bellvitge

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

124

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
    • Spain
      • L'Hospitalet de Llobregat, Spain, Spain, 08907

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Retromesenteric reconstruction
Procedure: Retromesenteric reconstruction
Perform a retromesenteric reconstruction after pancreaticoduodenectomy
Active Comparator: Transmesocolic reconstruction
Procedure: Transmesocolic reconstruction
Perform the standard reconstruction procedure (transmesocolic) pancreaticoduodenectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
From first postoperative day to 30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative morbility
Time Frame: Form first postoperative day to day 30
Postoperative morbidity at 90 days according to Clavien-Dindo classification (≥ Grade I)
Form first postoperative day to day 30
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)
From first postoperative day to day 30
Mortality
Time Frame: From first postoperative day to day 90
30- and 90-day mortality (any cause)
From first postoperative day to day 90
Hospital stay
Time Frame: From first postoperative day to hospital discharge up to 15 weeks
Postoperative hospital stay days (from surgery to hospital discharge)
From first postoperative day to hospital discharge up to 15 weeks
Operative time
Time Frame: Periprocedural time, an average time of 300-400 minutes
Total operative time (minutes)
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

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.
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
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.
From the first postoperative day to one year follow-up
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
From the first postoperative day to day 90
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
From the first postoperative day to day 90
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.
From the first postoperative day to day 90
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.
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
- Time to recurrence: Time elapsed from surgery to detection of recurrence (months).
From the first postoperative day to one year follow-up
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).
From the first postoperative day to one year follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitari de Bellvitge

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 31, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2028

Study Registration Dates

First Submitted

January 11, 2026

First Submitted That Met QC Criteria

January 18, 2026

First Posted (Actual)

January 26, 2026

Study Record Updates

Last Update Posted (Actual)

January 26, 2026

Last Update Submitted That Met QC Criteria

January 18, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUB-CIR-FAST

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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