NCT07368218

Brief 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
124

participants targeted

Target at P50-P75 for not_applicable pancreatic-cancer

Timeline
25mo left

Started Jan 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress11%
Jan 2026Jun 2028

First Submitted

Initial submission to the registry

January 11, 2026

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 26, 2026

Completed
5 days until next milestone

Study Start

First participant enrolled

January 31, 2026

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2028

Last Updated

January 26, 2026

Status Verified

January 1, 2026

Enrollment Period

1.3 years

First QC Date

January 11, 2026

Last Update Submit

January 18, 2026

Conditions

Pancreatic Cancer

Keywords

duodenopancreatectomyPancreatic cancerDelayed Gastric emptying

Outcome Measures

Primary Outcomes (1)

  • 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)

    From first postoperative day to 30 days

Secondary Outcomes (13)

  • Postoperative morbility

    Form first postoperative day to day 30

  • Pancreatic fistula

    From first postoperative day to day 30

  • Mortality

    From first postoperative day to day 90

  • Hospital stay

    From first postoperative day to hospital discharge up to 15 weeks

  • Operative time

    Periprocedural time, an average time of 300-400 minutes

  • +8 more secondary outcomes

Study Arms (2)

Retromesenteric reconstruction

EXPERIMENTAL
Procedure: Retromesenteric reconstruction

Transmesocolic reconstruction

ACTIVE COMPARATOR
Procedure: Transmesocolic reconstruction

Interventions

Retromesenteric reconstructionPROCEDURE

Perform a retromesenteric reconstruction after pancreaticoduodenectomy

Retromesenteric reconstruction
Transmesocolic reconstructionPROCEDURE

Perform the standard reconstruction procedure (transmesocolic) pancreaticoduodenectomy

Transmesocolic reconstruction

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18 years
  • Candidates for cephalic duodenopancreatectomy due to pancreatic pathology
  • Ability to complete follow-up questionnaires

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Universitari de Bellvitge

L'Hospitalet de Llobregat, Spain, 08907, Spain

Location

MeSH Terms

Conditions

Pancreatic NeoplasmsGastroparesis

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System DiseasesStomach DiseasesGastrointestinal DiseasesParalysisNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Juli Busquets Barenys, Md, PhD

CONTACT

93 260 75 00jbusquets@bellvitgehospital.cat

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Pancreatic Surgery Unit

Study Record Dates

First Submitted

January 11, 2026

First Posted

January 26, 2026

Study Start

January 31, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2028

Last Updated

January 26, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)