Can Administration of Etamsylate Reduce Postpancreatectomy Hemorrhage

Not Applicable

Not yet recruiting

• Conditions: Postpancreatectomy Hemorrhage
• Interventions: Drug: Etamsylate

• Registration Number: NCT06190535
• Lead Sponsor: University of Sfax

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.

Study Timeline

• Study First Submitted: 2023-12-18
• Status Verified: 2024-01
• Study Start: 2024-01-01
• Study First Submitted QC: 2024-01-03
• Last Update Submitted: 2024-01-03
• Study First Posted: 2024-01-05
• Last Update Posted: 2024-01-05
• Primary Completion: 2024-12-31
• Study Completion: 2025-03-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Rate of postoperative early (24-48 hours) digestive hemorrhage	24-48 hours, postoperative day Day 1, Day 2	Blood in NT, hematemesis in the postoperative course

Secondary Outcome Measures

Name	Time	Method
Operative mortality	30 day	In hospital or 30 day mortality

Trial Locations

Locations (1)

Ali Kchaou; 🇹🇳 Sfax, Tunisia