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IRCT2014020316473N1 IRCT 2014-02-26 Tabriz University of Medical Sciences Effects of adding Braun jejunojejunostomy to standard Whipple procedure on reduction of afferent loop syndrome- A Randomized control clinical trial . Braun jejunojejunostomy Effects of adding Braun jejunojejunostomy to standard Whipple procedure on reduction of afferent loop syndrome- A Randomized control clinical trial . 2013-05-22 anticipated 30 Complete https://irct.ir/trial/15408 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. N/A Condition 1: Malignant neoplasm: Head of pancreas. Condition 2: Malignant neoplasm: Ampulla of Vater. 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 5-10 centimeter distal to the pancreaticojejunostomy in 1 layer by 4-0 PDS separate sutures and the gastrojejunostomy will be done in ante colic manner 30-45 centimeter distal to the previous anastomosis. At the end of the procedure, two corrugate drain will be inserted in the liver bed and pancreatic bed in the right and left side respectively. Intervention 2: The intervention group will be undergone the standard Whipple procedure plus Braun jejunojejunostomy. Two layer ductojejunostomy will be used for pancreaticojejunostomy anastomosis. Choledochojejunostomy will be done 5-10 centimeter distal to the pancreaticojejunostomy in 1 layer by 4-0 PDS separate sutures and the gastrojejunostomy will be done in ante colic manner 30-45 centimeter distal to the previous anastomosis. Braun jejunojejunostomy will be done in 2 layer by PDS 2-0 in standard manner, the distance between the anastomosis and choledochojejunostomy anastomosis will be near 30 centimeter and the distal loop will be near 40 centimeter. At the end of the procedure, two corrugate drain will be inserted in the liver bed and pancreatic bed in the right and left side respectively.
public Farzad Kakaei
Imam Reza hospital
Tabriz Iran (Islamic Republic of) +98 41 1334 1317 fkakaei@yahoo.com Tabriz University of Medical Sciences scientific Farzad Kakaei
Imam Reza hospital
Tabriz Iran (Islamic Republic of) +98 41 1334 1317 fkakaei@yahoo.com Tabriz University of Medical Ssciences Iran (Islamic Republic of) 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 18 years 75 years Both C25.0 C24.1 Malignant neoplasm: Head of pancreas Malignant neoplasm: Ampulla of Vater Treatment - Surgery 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 distal to the pancreaticojejunostomy in 1 layer by 4-0 PDS separate sutures and the gastrojejunostomy will be done in ante colic manner 30-45 centimeter distal to the previous anastomosis. At the end of the procedure, two corrugate drain will be inserted in the liver bed and pancreatic bed in the right and left side respectively. The intervention group will be undergone the standard Whipple procedure plus Braun jejunojejunostomy. Two layer ductojejunostomy will be used for pancreaticojejunostomy anastomosis. Choledochojejunostomy will be done 5-10 centimeter distal to the pancreaticojejunostomy in 1 layer by 4-0 PDS separate sutures and the gastrojejunostomy will be done in ante colic manner 30-45 centimeter distal to the previous anastomosis. Braun jejunojejunostomy will be done in 2 layer by PDS 2-0 in standard manner, the distance between the anastomosis and choledochojejunostomy anastomosis will be near 30 centimeter and the distal loop will be near 40 centimeter. At the end of the procedure, two corrugate drain will be inserted in the liver bed and pancreatic bed in the right and left side respectively. 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). 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. Tabriz University of Medical Sciences Approved 2013-09-30 Tabriz University of Medical Sciences Golgasht Street Tabriz Iran (Islamic Republic of)