Condition 1: Malignant neoplasm: Head of pancreas. Condition 2: Malignant neoplasm: Ampulla of Vater. Malignant neoplasm: Head of pancreas Malignant neoplasm: Ampulla of Vater
Conditions
Interventions
Intervention 1: The control group will be undergone the standard Whipple procedure. Two layer ductojejunostomy will be used for pancreaticojejunostomy anastomosis. Choledochojejunostomy will be done 5
Treatment - Surgery
The control group will be undergone the standard Whipple procedure. Two layer ductojejunostomy will be used for pancreaticojejunostomy anastomosis. Choledochojejunostomy will be done 5-10 centimeter d
The intervention group will be undergone the standard Whipple procedure plus Braun jejunojejunostomy. Two layer ductojejunostomy will be used for pancreaticojejunostomy anastomosis. Choledochojejunost
Sponsors
Tabriz University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria: age between 18-75 years; operability according to the preoperative imaging studies ( no invasion to portal vein, superior mesenteric artery or superior mesenteric vein, no distant metastasis, no invasion to adjacent organs); presence of pancreatic head,or duodenal, or common bile duct tumor which needs Whipple procedure Exclusion criteria: age over 75 or less than 18; death during the operation; inoperability according to any intraoperative findings
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Afferent loop syndrome. Timepoint: during the hospital stay after the thirdth day after the operation. Method of measurement: Questinaire (sudden bulky bile stained vomitus without any relation to eating). | — |
Secondary
| Measure | Time frame |
|---|---|
| Postoperative death. Timepoint: during the total hospital stay. Method of measurement: questionnaire.;Pancreatic anastomosis leakage. Timepoint: daily till discharge. Method of measurement: questionnaire (high amylase drainage from drains).;Gastric anastomosis leakage. Timepoint: daily till discharge. Method of measurement: questionnaire (low pH drainage from drains).;Biliary anastomosis leakage. Timepoint: daily till discharge. Method of measurement: questionnaire (high bilirubin drainage from drains).;Postoperative bleeding which needs another operation. Timepoint: daily till discharge. Method of measurement: questionnaire.;Postoperative gastrointestinal bleeding which needs repeat operation. Timepoint: daily till discharge. Method of measurement: questionnaire.;Surgical site infection. Timepoint: daily till discharge. Method of measurement: questionnaire. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactFarzad Kakaei
Tabriz University of Medical Sciences
Outcome results
None listed