Gastric Emptying After Infracolic or Supracolic Gastrojejunostomy Following Pancreaticoduodenectomy
Primary Purpose
Postprocedural Gastric Stasis
Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Infracolic gastrojejunal anastamosis
Supracolic gastrojejunal anastamosis
Sponsored by
About this trial
This is an interventional prevention trial for Postprocedural Gastric Stasis focused on measuring Delayed Gastric emptying, Gastric emptying scintigraphy, Pancreatic fistula, Pancreatic Neoplasms, Whipple Operation
Eligibility Criteria
Inclusion Criteria:
- Patients undergoing Whipples procedure
Exclusion Criteria:
- Unresectable tumors at surgery
- Postoperative mechanical obstruction
- Postoperative mortality, where the test could not be done
Sites / Locations
- Asian Institute Of Gastroenterology India
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Infracolic Anastamosis
Supracolic Anastamosis
Arm Description
The gastrojejunal anastamosis is done in the infracolic compartment
The gastrojejunal anastamosis is done in the supracolic compartment
Outcomes
Primary Outcome Measures
Gastric Emptying assessed clinically and correlated objectively with liquid and solid emptying of radionucleotide
Gastric emptying in the postoperative period in the form of tolerence of food and removal of ryles tube is assessed. This is correlated with liquid and solid emptying of radionucleotide
Secondary Outcome Measures
Correlation of pancreatic duct leak with gastric emptying
The pancreatic duct leak is correlated with gastric emptying
Full Information
NCT ID
NCT01191138
First Posted
August 26, 2010
Last Updated
June 19, 2012
Sponsor
Asian Institute of Gastroenterology, India
Collaborators
KK Nuclear Scan
1. Study Identification
Unique Protocol Identification Number
NCT01191138
Brief Title
Gastric Emptying After Infracolic or Supracolic Gastrojejunostomy Following Pancreaticoduodenectomy
Official Title
Randomized Control Trial Comparing Gastric Emptying Following Infracolic vs Supracolic Gastrojejunostomy After Whipples Pancreaticoduodenectomy
Study Type
Interventional
2. Study Status
Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
March 2012 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Asian Institute of Gastroenterology, India
Collaborators
KK Nuclear Scan
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Patients undergoing whipples pancreaticoduodenectomy tend to develop delayed gastric emptying.
The study compares two types of anastamosis of stomach to jejunum (supracolic and infracolic) and compares whether it influences the gastric emptying.
The clinical evidence of delayed gastric emptying is correlated with objective evidence of liquid and solid emptying by radionuclide study.
The study also tries to evaluate whether pancreatic leak correlates with delayed gastric emptying
Detailed Description
METHODOLOGY:
This randomized control trial includes all patients undergoing whipples pancreaticoduodenectomy st Asian Institute of Gastroenterology. All patients were randomized by a closed envelope technique. The envelope was opened after complete resection of the specimen and then allocating the patients into either of the two groups, Group A- Infracolic Gastrojejunostomy, Group B- Supracolic Gastrojejunostomy.
Inclusion Criteria:
All patients undergoing whipples pancreaticoduodenectomy, who consented for the trial and found to be resectable at surgery.
Exclusion Criteria:
Unresectable tumors at surgery
Patients in whom gastric emptying studies could not be done due to any reason
Documented Mechanical obstruction at Gastrojejunal anastamosis
Post operative mortality due to other causes
After the resection, a Roux loop of jejunum is prepared and taken up through a rent in the transverse mesocolon to which an end to side Hepaticojejunostomy followed by Pancreaticojejunostomy is done in both the groups.
In Group A Infracolic gastrojejunostomy is done in the infracolic compartment to the same loop of jejunum after pulling the stomach down through another rent in the transverse mesocolon to the left of middle colic artery, thereby compartmentalizing or separating gastrojejunostomy from Hepaticojejunostomy and pancreaticojejunostomy.
In Group B Supracolic gastrojejunostomy is done in the supracolic compartment to the same Roux loop of jejunum.
All the patients undergo a feeding jejunostomy. Postoperatively all the patients were managed according to a standard protocol, daily monitoring of Ryle's tube output and drain fluid output was recorded. Drain fluid amylase levels and serum amylase levels were estimated on postoperative day 3, 5 and 7. Ryle's tube was removed if the output was <200ml in 24hrs after confirming that the tube was patent.
Oral feeds were started after removal of Ryle's tube, initially with liquids followed by semisolids and then normal diet. Patient's daily intake is recorded. Any adverse event of vomiting, abdominal distension and succussion splash was recorded by the person blinded about the technique of anastamosis. If there was clinical suspicion of gastric outlet obstruction, Ryle's tube was placed and output recorded. If mechanical cause for gastric outlet obstruction was suspected, then contrast study and/or gastroscopy was done to confirm.
Graded enteral nutrition was started in all the patients from post operative day 3 through the feeding jejunostomy tube.
Any medications effecting GI motility were avoided till the gastric emptying studies were performed
Clinically delayed gastric emptying was defined according to International study group of pancreatic Surgeons (ISGPS), as Grade A, B and C. Pancreatic fistula was defined based on International Study Group on Pancreatic Fistula (ISGPF) as Grade A, B and C.
Radio isotope gastric emptying studies were done for both liquids and solids on postoperative day 7 & 8 respectively. Test was performed and interpreted by the investigator who is blinded about the type of anastamosis.
At the end the groups will be analyzed whether they were comparable with regard to the age, sex and diagnosis. The gastric emptying (Clinical, liquid meal and solid meal emptying) will be compared between both procedure groups. Correlation of clinical evidence of gastric emptying with liquid and solid emptying is calculated. Correlation of pancreatic anastomotic leak with gastric emptying is also done.
PROTOCOL OF GASTRIC EMRTYING STUDY:
Liquid study on one day & solid study on the next day
Tracer to be use:
Tc99m-DTPA in water 400ml for 70 Kg adult; volume to be adjusted based on patient weight, is used for liquid emptying study.
Tc99m-Pertechnetate labeled with Idly during cooking, 300gm for 70 Kg adult; volume to be adjusted based on patient weight, is used for solid emptying study.
IMAGING TECHNIQUE:
Sequential static images are to be obtained with patient in erect position from anterior & posterior projections of the abdomen Liquids - 1min image for every 15min for 90mins (to be extended to 120 mins if necessary).
Solids - 1min image for every 30min for 4hrs (to be extended if necessary).
IMAGE PROCESSING:
Region of interest to be generated over stomach region, after verifying with the surgeon initially for standardization Now Geometric mean of counts calculated from the stomach and used to generate the time activity curve, percentage emptying at different time intervals and T1/2 to be calculated.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postprocedural Gastric Stasis
Keywords
Delayed Gastric emptying, Gastric emptying scintigraphy, Pancreatic fistula, Pancreatic Neoplasms, Whipple Operation
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Infracolic Anastamosis
Arm Type
Other
Arm Description
The gastrojejunal anastamosis is done in the infracolic compartment
Arm Title
Supracolic Anastamosis
Arm Type
Other
Arm Description
The gastrojejunal anastamosis is done in the supracolic compartment
Intervention Type
Procedure
Intervention Name(s)
Infracolic gastrojejunal anastamosis
Other Intervention Name(s)
Infracolic and retrocolic Gastrojejunostomy
Intervention Description
Following resection in whipples pancreaticoduodenectomy, the gastrojejunal anastamosis is done in the infracolic compartment by bringing down the stomach below the mesocolon to the left of the middle colic artery
Intervention Type
Procedure
Intervention Name(s)
Supracolic gastrojejunal anastamosis
Other Intervention Name(s)
Supracolic and retrocolic gastrojejunostomy
Intervention Description
Following resection in whipples pancreaticoduodenectomy, the gastrojejunal anastamosis is done in the supracolic compartment.
Primary Outcome Measure Information:
Title
Gastric Emptying assessed clinically and correlated objectively with liquid and solid emptying of radionucleotide
Description
Gastric emptying in the postoperative period in the form of tolerence of food and removal of ryles tube is assessed. This is correlated with liquid and solid emptying of radionucleotide
Time Frame
30 days after surgery
Secondary Outcome Measure Information:
Title
Correlation of pancreatic duct leak with gastric emptying
Description
The pancreatic duct leak is correlated with gastric emptying
Time Frame
30 days after surgery
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients undergoing Whipples procedure
Exclusion Criteria:
Unresectable tumors at surgery
Postoperative mechanical obstruction
Postoperative mortality, where the test could not be done
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pradeep Rebala, MS., M Ch
Organizational Affiliation
Asian Institute of Gastroenterology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Asian Institute Of Gastroenterology India
City
Hyderabad
State/Province
Andhra Pradesh
ZIP/Postal Code
500082
Country
India
12. IPD Sharing Statement
Learn more about this trial
Gastric Emptying After Infracolic or Supracolic Gastrojejunostomy Following Pancreaticoduodenectomy
We'll reach out to this number within 24 hrs