Postprocedural Gastric StasisNCT01191138
Gastric Emptying After Infracolic or Supracolic Gastrojejunostomy Following Pancreaticoduodenectomy
A study testing Infracolic gastrojejunal anastamosis and Supracolic gastrojejunal anastamosis in people with Postprocedural Gastric Stasis, run by Asian Institute of Gastroenterology, India at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Postprocedural Gastric Stasis
- What is being tested?
- Infracolic gastrojejunal anastamosis and Supracolic gastrojejunal anastamosis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIndia
- Study dates
- Jan 2009to Mar 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients undergoing Whipples procedure
Who cannot join
- Unresectable tumors at surgery
- Postoperative mechanical obstruction
- Postoperative mortality, where the test could not be done
Trial locations and contacts
1 site in 1 country.
India1 site
Asian Institute Of Gastroenterology India
Hyderabad, Andhra Pradesh, 500082
About this study
Official title: Randomized Control Trial Comparing Gastric Emptying Following Infracolic vs Supracolic Gastrojejunostomy After Whipples Pancreaticoduodenectomy
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
Read the 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.
- Conditions
- Postprocedural Gastric Stasis
- Being tested
- Infracolic gastrojejunal anastamosis, Supracolic gastrojejunal anastamosis
- Keywords
- Delayed Gastric emptying, Gastric emptying scintigraphy, Pancreatic fistula, Pancreatic Neoplasms, Whipple Operation
- Medical subject headings
- Gastroparesis, Pancreatic Fistula, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infracolic gastrojejunal anastamosisProcedure or surgery
Also called Infracolic and retrocolic Gastrojejunostomy
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
Supracolic gastrojejunal anastamosisProcedure or surgery
Also called Supracolic and retrocolic gastrojejunostomy
Following resection in whipples pancreaticoduodenectomy, the gastrojejunal anastamosis is done in the supracolic compartment.
| Study group | Role | What they receive |
|---|---|---|
| Infracolic Anastamosis | Other | The gastrojejunal anastamosis is done in the infracolic compartment Receives: Procedure: Infracolic gastrojejunal anastamosis |
| Supracolic Anastamosis | Other | The gastrojejunal anastamosis is done in the supracolic compartment Receives: Procedure: Supracolic gastrojejunal anastamosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 30 days after surgery
Secondary outcomes (1)
Correlation of pancreatic duct leak with gastric emptying
The pancreatic duct leak is correlated with gastric emptying
Measured: 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2010 (estimated)
- Study startJan 2009
- Primary completionFeb 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postprocedural Gastric StasisStudies of the same condition, open and under way.
- More trials run by Asian Institute of Gastroenterology, IndiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asian Institute of Gastroenterology, India
- Sponsor type
- University, hospital or other
- Collaborators
- KK Nuclear Scan
- Investigators
- Pradeep Rebala, MS., M Ch, Principal investigator, Asian Institute of Gastroenterology, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01191138
- Sponsor's protocol ID
- AIG-GIS-20090
- Status last verified
- Jun 2012
- First submitted
- 26 Aug 2010
- Last updated
- 20 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Control Trial Comparing Gastric Emptying Following Infracolic vs Supracolic Gastrojejunostomy After Whipples Pancreaticoduodenectomy
- ClinicalTrials.gov ID
- NCT01191138
- Acronym / sponsor ID
- AIG-GIS-20090
- Conditions
- Postprocedural Gastric Stasis
- Keywords
- Delayed Gastric emptying, Gastric emptying scintigraphy, Pancreatic fistula, Pancreatic Neoplasms, Whipple Operation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Asian Institute of Gastroenterology, IndiaUniversity, hospital or other
- Collaborators
- KK Nuclear Scan
- Study start
- Jan 2009
- Primary completion
- Feb 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 30 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Infracolic Anastamosis | Other | Procedure: Infracolic gastrojejunal anastamosisThe gastrojejunal anastamosis is done in the infracolic compartment |
| Supracolic Anastamosis | Other | Procedure: Supracolic gastrojejunal anastamosisThe gastrojejunal anastamosis is done in the supracolic compartment |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing Whipples procedure
Key exclusion criteria (3 listed)
- Unresectable tumors at surgery
- Postoperative mechanical obstruction
- Postoperative mortality, where the test could not be done
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Infracolic gastrojejunal anastamosisAlso: Infracolic and retrocolic GastrojejunostomyFollowing 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 | Procedure or surgery | Infracolic Anastamosis |
| Supracolic gastrojejunal anastamosisAlso: Supracolic and retrocolic gastrojejunostomyFollowing resection in whipples pancreaticoduodenectomy, the gastrojejunal anastamosis is done in the supracolic compartment. | Procedure or surgery | Supracolic Anastamosis |
Primary outcome
Gastric Emptying assessed clinically and correlated objectively with liquid and solid emptying of radionucleotide
Time frame: 30 days after surgery
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
1 secondary outcome
Correlation of pancreatic duct leak with gastric emptying
Time frame: 30 days after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pradeep Rebala, MS., M Ch principal investigator
Asian Institute of Gastroenterology, India
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Infracolic gastrojejunal anastamosis and Supracolic gastrojejunal anastamosis in people with Postprocedural Gastric Stasis, run by Asian Institute of Gastroenterology, India at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gastric Emptying assessed clinically and correlated objectively with liquid and solid emptying of radionucleotide (time frame: 30 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2012.