An interventional study of Retromesenteric reconstruction and Transmesocolic reconstruction in Pancreatic Cancer, sponsored by Hospital Universitari de Bellvitge. Not yet recruiting at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-26.
Sponsored by Hospital Universitari de Bellvitge · Not applicable, Interventional, and Treatment
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.
3,235 studies on the registry are indexed under Pancreatic Neoplasms; 899 are open to participants now.
This study's planned enrollment of 124 is above the median of 46 across 2,424 interventional studies indexed under Pancreatic Neoplasms.
Browse Pancreatic Neoplasms studies →Hospital Universitari de Bellvitge is the lead sponsor of 118 studies on the registry; 29 are open to participants now.
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Exclusion Criteria:
Procedure: Retromesenteric reconstruction
Procedure: Transmesocolic reconstruction
Perform a retromesenteric reconstruction after pancreaticoduodenectomy
Perform the standard reconstruction procedure (transmesocolic) pancreaticoduodenectomy
Delayed Gastric Emptying
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)
Time frame: From first postoperative day to 30 days
Postoperative morbility
Postoperative morbidity at 90 days according to Clavien-Dindo classification (≥ Grade I)
Time frame: Form first postoperative day to day 30
Pancreatic fistula
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)
Time frame: From first postoperative day to day 30
Mortality
30- and 90-day mortality (any cause)
Time frame: From first postoperative day to day 90
Hospital stay
Postoperative hospital stay days (from surgery to hospital discharge)
Time frame: From first postoperative day to hospital discharge up to 15 weeks
Operative time
Total operative time (minutes)
Time frame: Periprocedural time, an average time of 300-400 minutes
Proportion of patients with NLR index ≥5
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.
Time frame: From the first postoperative day to one year follow-up
Proportion of patients with CA19.9 >37 U/ml
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.
Time frame: From the first postoperative day to one year follow-up
Cytokines in serum
* 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
Time frame: From the first postoperative day to day 90
Cytokines in abdominal drainage
* 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
Time frame: From the first postoperative day to day 90
Cytokines and complications correlation
Exploratory analysis of the association between cytokine levels and the appearance of complications during the first 90 days.
Time frame: From the first postoperative day to day 90
Recurrence
\- Recurrence of malignant pathology: Defined as the appearance of local, regional, or distant disease documented by imaging techniques (CT/MRI) or histopathological confirmation.
Time frame: From the first postoperative day to one year follow-up
Time to recurrence
\- Time to recurrence: Time elapsed from surgery to detection of recurrence (months).
Time frame: From the first postoperative day to one year follow-up
Complications-recurrence correlation
Association analysis between the presence of complications (Clavien-Dindo ≥ II) and early recurrence (≤12 months).
Time frame: From the first postoperative day to one year follow-up
Plan to share: No
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Hospital Universitari de Bellvitge