NCT06190535

Brief Summary

In several studies comparing the tow types of pancreato-digestive anastomosis: pancreatogastrostomy (PG) and pancreatojejunostomy (PJ), authors concluded that PG exposed to more postpancreatectomy hemorrhage (PPH) especially early, digestive and moderate hemorrhage classified as type A according to the classification of the ISGPS. In this way we try to test the ability of the enteral administration through the nasogastric tube of Etamsylate for 48 hours after Whipple to reduce the rate of digestive PPH and mortality.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 18, 2023

Completed
14 days until next milestone

Study Start

First participant enrolled

January 1, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 5, 2024

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2025

Completed
Last Updated

January 5, 2024

Status Verified

January 1, 2024

Enrollment Period

1 year

First QC Date

December 18, 2023

Last Update Submit

January 3, 2024

Conditions

Postpancreatectomy Hemorrhage

Outcome Measures

Primary Outcomes (1)

  • Rate of postoperative early (24-48 hours) digestive hemorrhage

    Blood in NT, hematemesis in the postoperative course

    24-48 hours, postoperative day Day 1, Day 2

Secondary Outcomes (1)

  • Operative mortality

    30 day

Study Arms (2)

Etamsylate +

EXPERIMENTAL

Arm in which etamsylate (Dicynone injectable 250mg/2ml) is administrated through the nasogastric tube (NT) 2 ampules twice (X2)/day for 48 hours.

Drug: Etamsylate

the standard postoperative treatment

NO INTERVENTION

Arm in which patients have the standard postoperative treatment

Interventions

EtamsylateDRUG

Enteral administration of Etamsylate as solution galenic form

Etamsylate +

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patients undergoing Whipple procedure regardless the type of pathology and in which a PG is performed.

You may not qualify if:

  • Patients undergoing Whipple procedure regardless the type of pathology and in which a PJ is performed.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ali Kchaou

Sfax, 3029, Tunisia

Location

MeSH Terms

Interventions

Ethamsylate

Intervention Hierarchy (Ancestors)

BenzenesulfonatesBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsArylsulfonatesArylsulfonic AcidsSulfonic AcidsSulfur AcidsSulfur Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ali Kchaou MD FACS

Study Record Dates

First Submitted

December 18, 2023

First Posted

January 5, 2024

Study Start

January 1, 2024

Primary Completion

December 31, 2024

Study Completion

March 30, 2025

Last Updated

January 5, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)