Postpancreatectomy Hemorrhage
Conditions
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.
Interventions
DRUGEtamsylate
Enteral administration of Etamsylate as solution galenic form
Sponsors
University of Sfax
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Operative mortality | 30 day | In hospital or 30 day mortality |
Countries
Tunisia
Outcome results
None listed