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

Catalan Institute of Health

Status: Not yet enrolling

Conditions: Pancreatic Cancer

Treatments: Procedure: Retromesenteric reconstruction; Procedure: Transmesocolic reconstruction

Study type: Interventional

Funder types: Other

Identifiers

NCT07368218

HUB-CIR-FAST

Details and patient eligibility

About

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.

Enrollment: 124 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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124 participants in 2 patient groups

Retromesenteric reconstruction

Experimental group

Treatment:

Procedure: Retromesenteric reconstruction

Transmesocolic reconstruction

Active Comparator group

Treatment:

Procedure: Transmesocolic reconstruction