The aim of this study was to assess improved outcomes in patients with pancreatic head tumor who underwent pancreaticojejunostomy by muscetomy technique during whipple procedure. The patients will consist of subjects with pancreatic head tumor which are resectable by whipple procedure. A total of 20 patients will be studied during one year from April 2013. The patients will randomly be divided into two groups. In both groups, whipple procedure will be conducted for resection of head of the pancreas. In mucosectomy group (Group 1), anastomosis of pancreaticojejunostomy will be done by musectomy technique, while in the routine group (Group 2) routine anastomosis techniques will be applied. Age, sex, size of tumor and preoperative serum albumin level would be recorded for all patients. Size of pancreatic duct and fragility of pancreatic tissue will also be recorded. Leak of pancreaticojejunostomy will be assessed by development of pancreatic fistula. Postoperative admission days, NPO (nul per os) days, infectious complications, the need for blood transfusion and octreotide use will be recorded for all patients. The outcomes will be compared between two groups to evaluate possible beneficial effects of mucosectomy technique. The comparison of ouctomes between two groups will be double-blind and the surgeon who evaluates patients postoperatively will not be aware of the patients' anastomosis technique.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013060113545N1
Registration date:2014-03-22, 1393/01/02
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-03-22, 1393/01/02
Registrant information
Name
Fariborz Rousta
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1334 1317
Email address
fariborz_rousta@irimc.org
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2013-05-08, 1392/02/18
Expected recruitment end date
2014-05-08, 1393/02/18
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of pancreaticojejunostomy by mocusectomy technique and its routine method in whipple surgery
Public title
Pancreaticojejunostomy by mocusectomy technique in whipple procedure
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1-Mass of head of pancreas; 2-Being candidate for whipple procedure;3- Being more than 18 years of age
Exclusion criteria: Involvement of other parts of pancreas; Metastasis; Inoperable presentation; being high risk for whipple procedure
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single 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 St. Research Vice Chancellor Office, Tabriz University of Medical Sciences
City
Tabriz
Postal code
51664
Approval date
2013-05-08, 1392/02/18
Ethics committee reference number
9224
Health conditions studied
1
Description of health condition studied
Pancreatic head tumor
ICD-10 code
K86.9
ICD-10 code description
Disease of pancreas, unspecified
Primary outcomes
1
Description
Aanstomotic leak
Timepoint
10 days after operation
Method of measurement
Physical examination, assessment of outputs of drains and assessment of presence of pancreatic fistula
Secondary outcomes
1
Description
Postoperative conditions
Timepoint
10 days after the operation
Method of measurement
Postoperative admission days, NPO days, the need for blood transfusion and octreotide use
Intervention groups
1
Description
The intervention of this trial would be the musectomy technique. This would be applied for intervention group (musectomy group) during pancreaticojejunostomy anastomosis. In control group, pancreaticojejunostomy anastomosis will be done by routine technique. For musectomy, 3-5 mm of mucosa of jejunum will be resected by this scalpel and then pancreaticojejunostomy anastomosis will be done between mucosa of jejunum (distal to mucosectomy) and the pancreas. Then mascular layer of distal part of jejunum (the site of mucosectmy) will be attached to the pancreatic tissue by separate sutures.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Hemmat Maghsoudi
Street address
Golgast St. tabriz University of Medical Sciences
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Hemmat Maghsoudi
Street address
Golgasht St. Tabriz University of Medical Sciences
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
Dr. Hemmat Maghsoudi
Position
MD, Professor
Other areas of specialty/work
Street address
Department of General Surgery, Tabriz University of Medical Sciences
City
Tabriz
Postal code
Phone
+98 41 1334 1317
Fax
Email
maghsoudih@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz Univetsity of Medical Sciences
Full name of responsible person
Dr. Hemmat Maghsoudi
Position
MD, Professor
Other areas of specialty/work
Street address
Department of General Surgery, Tabriz University of Medical Sciences
City
Tabriz
Postal code
Phone
+98 41 1334 1317
Fax
Email
maghsoudih@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
Fariborz Rousta
Position
MD, Resident of General Surgery
Other areas of specialty/work
Street address
Department of General Suregry, Tabriz University of Medical Sciences
City
Tabriz
Postal code
Phone
00
Fax
Email
fariborz_rousta@irimc.org
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)