NCT07368218

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

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)

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 124 (estimated)
• Sponsor: Hospital Universitari de Bellvitge · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Pancreatic Cancer

Interventions

Type	Name	Description
PROCEDURE	Retromesenteric reconstruction	Perform a retromesenteric reconstruction after pancreaticoduodenectomy
PROCEDURE	Transmesocolic reconstruction	Perform the standard reconstruction procedure (transmesocolic) pancreaticoduodenectomy

Timeline

• Start date: 2026-01-31
• Primary completion: 2027-06-01
• Completion: 2028-06-01
• First posted: 2026-01-26
• Last updated: 2026-01-26

Locations

1 site across 1 country: Spain