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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in India

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:

  1. Tc99m-DTPA in water 400ml for 70 Kg adult; volume to be adjusted based on patient weight, is used for liquid emptying study.
  2. 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.

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 groups in NCT01191138
Study groupRoleWhat they receive
Infracolic AnastamosisOtherThe gastrojejunal anastamosis is done in the infracolic compartment
Receives: Procedure: Infracolic gastrojejunal anastamosis
Supracolic AnastamosisOtherThe 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.

  1. 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)
  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.

  1. First posted30 Aug 2010 (estimated)
  2. Study startJan 2009
  3. Primary completionFeb 2012
  4. Study completionMar 2012

Resources

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)
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

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.

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