Can Administration of Etamsylate Reduce Postpancreatectomy Hemorrhage

NCT ID: NCT06190535

Last Updated: 2024-01-05

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-01
• Study Completion Date: 2025-03-30

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.

Detailed Description

Whipple procedure is usually performed for periampullary malignancies. If the mortality of this intervention has been markedly decreased, it persists a morbid one. Morbidity is mainly due to postoperative leak of the pancreato-digestive anastomosis or postoperative pancreatic fistula (POPF), but also to postpancreatectomy hemorrhage (PPH). 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 case of hemorrhage, blood generally comes from pancreatic stump which is anastomosed or telescoped in the stomac. Incomplete hemostasis , soft pancreatic tissue and vascular fragility can help PPH to occur.

Etamsylate is an antihemorrhagic agent which works by increasing the resistance in the endothelium of capillaries and stimulating platelet adhesion. It also inhibits synthesis and action of prostaglandins causing platelet disaggregation, vasodilation and increased capillary permeability.

In this way, the investigators 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.

Conditions

Postpancreatectomy Hemorrhage

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Etamsylate +

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

Group Type: EXPERIMENTAL

Etamsylate

Intervention Type: DRUG

Enteral administration of Etamsylate as solution galenic form

the standard postoperative treatment

Arm in which patients have the standard postoperative treatment

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Etamsylate

Enteral administration of Etamsylate as solution galenic form

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Sfax

OTHER

Sponsor Role: lead

Responsible Party

Ali Kchaou

Ali Kchaou MD FACS

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ali Kchaou

Sfax, , Tunisia

Countries

Tunisia

Facility Contacts

Ali Kchaou, MD

Role: primary

kchaouali179@gmail.com

0021622815765

Ahmed Tlili, MD

Role: backup

ahmed_wuchu@yahoo.fr

0021624101075

Other Identifiers

PGPPH1

Identifier Type: -

Identifier Source: org_study_id