Protocol summary

Summary
30 patients(18-75Y/O) of pancreatic head, duodenal or common bile duct tumor which need Whipple procedurewhich are operable according to the preoperative imaging studies will be recruited for this studyand will be randomized by Randlist software into 2 equal groups.The control group will be undergone the standard Whipple procedure. In the intervention group a Braun jejunojejunostomy will be added to the standard procedure.Those who are inoperable according to intraoperative findings or those who die during the operation will be excluded from the study.The following variables will be collected by a questionnaire to compare between the two groups:age, gender, body mass index, time from the first symptoms till the operation, cause of the disease ( pancreatic head,or duodenal, or common bile duct tumor), duration of the operation, intraoperative bleeding, total volume of intraoperative blood product transfusion, pre- and postoperative lab data (WBC, Hb, ALT, AST, Total and direct bilirubin) in days 1, 3, 5, 7 and 14, volume of nasogastric tube evacuations for 48 hours after the operation, daily number of vomitings after extraction of nasogastric tubes, postoperative complications including death and its cause, pancreatic anastomosis leakage, gastric anastomosis leakage, biliary anastomosis leakage, postoperative bleeding which needs another operation, postoperative gastrointestinal bleeding which needs repeat operation, afferent loop syndrome, delayed gastric emptying,surgical site infection, pulmonary infection, confirmed deep vein thrombosis. Follow-up of the patients will be continued till 1 month after the operation or in-hospital death.

General information

Acronym
Braun jejunojejunostomy
IRCT registration information
IRCT registration number: IRCT2014020316473N1
Registration date: 2014-02-26, 1392/12/07
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2014-02-26, 1392/12/07
Registrant information
Name
Farzad Kakaei
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1334 1317
Email address
fkakaei@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2013-05-22, 1392/03/01
Expected recruitment end date
2014-03-20, 1392/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of adding Braun jejunojejunostomy to standard Whipple procedure on reduction of afferent loop syndrome- A Randomized control clinical trial .
Public title
Effects of adding Braun jejunojejunostomy to standard Whipple procedure on reduction of afferent loop syndrome- A Randomized control clinical trial .
Purpose
Treatment
Inclusion/Exclusion 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
Age
From 18 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Tabriz University of Medical Sciences
Street address
Golgasht Street
City
Tabriz
Postal code
Approval date
2013-09-30, 1392/07/08
Ethics committee reference number
92106

Health conditions studied

1

Description of health condition studied
Malignant neoplasm: Head of pancreas
ICD-10 code
C25.0
ICD-10 code description
Malignant neoplasm: Head of pancreas

2

Description of health condition studied
Malignant neoplasm: Ampulla of Vater
ICD-10 code
C24.1
ICD-10 code description
Malignant neoplasm: Ampulla of Vater

Primary outcomes

1

Description
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 outcomes

1

Description
postoperative death
Timepoint
during the total hospital stay
Method of measurement
questionnaire

2

Description
pancreatic anastomosis leakage
Timepoint
daily till discharge
Method of measurement
questionnaire (high amylase drainage from drains)

3

Description
gastric anastomosis leakage
Timepoint
daily till discharge
Method of measurement
questionnaire (low pH drainage from drains)

4

Description
biliary anastomosis leakage
Timepoint
daily till discharge
Method of measurement
questionnaire (high bilirubin drainage from drains)

5

Description
postoperative bleeding which needs another operation
Timepoint
daily till discharge
Method of measurement
questionnaire

6

Description
postoperative gastrointestinal bleeding which needs repeat operation
Timepoint
daily till discharge
Method of measurement
questionnaire

7

Description
surgical site infection
Timepoint
daily till discharge
Method of measurement
questionnaire

Intervention groups

1

Description
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.
Category
Treatment - Surgery

2

Description
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.
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
surgery unit of Tabriz Imam Reza hospital
Full name of responsible person
Dr Farzad Kakaei
Street address
Golgasht Street
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mohammad Reza Rashidi
Street address
Golgasht Street
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Farzad Kakaei
Position
associate professor of surgery
Other areas of specialty/work
Street address
Imam Reza hospital
City
Tabriz
Postal code
Phone
+98 41 1334 1317
Fax
+98 41 1334 1317
Email
fkakaei@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Ssciences
Full name of responsible person
Farzad Kakaei
Position
Associate professor of surgery
Other areas of specialty/work
Street address
Imam Reza hospital
City
Tabriz
Postal code
Phone
+98 41 1334 1317
Fax
+98 41 1334 1317
Email
fkakaei@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Farzad Kakaei
Position
Associate professor of surgery
Other areas of specialty/work
Street address
Imam Reza hospital
City
Tabriz
Postal code
Phone
+98 41 1334 1317
Fax
+98 41 1334 1317
Email
fkakaei@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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