Clinical trial · Interventional
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Retromesenteric reconstruction | Procedure | — | UNRESOLVED |
| Transmesocolic reconstruction | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Retromesenteric reconstruction
- interventionNames
- Procedure: Retromesenteric reconstruction
- type
- ACTIVE_COMPARATOR
- label
- Transmesocolic reconstruction
- interventionNames
- Procedure: Transmesocolic reconstruction
Primary outcomes (1)
- measure
- Delayed Gastric Emptying
- timeFrame
- From first postoperative day to 30 days
- description
- 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)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available