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Gastric Emptying After Infracolic or Supracolic Gastrojejunostomy Following Pancreaticoduodenectomy

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ClinicalTrials.gov Identifier: NCT01191138
Recruitment Status : Completed
First Posted : August 30, 2010
Last Update Posted : June 20, 2012
Sponsor:
Collaborator:
KK Nuclear Scan
Information provided by:
Asian Institute of Gastroenterology, India

August 26, 2010
August 30, 2010
June 20, 2012
January 2009
February 2012   (Final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01191138 on ClinicalTrials.gov Archive Site
Correlation of pancreatic duct leak with gastric emptying [ Time Frame: 30 days after surgery ]
The pancreatic duct leak is correlated with gastric emptying
Same as current
Not Provided
Not Provided
 
Gastric Emptying After Infracolic or Supracolic Gastrojejunostomy Following Pancreaticoduodenectomy
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

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.

Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Postprocedural Gastric Stasis
  • Procedure: Infracolic gastrojejunal anastamosis
    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
    Other Name: Infracolic and retrocolic Gastrojejunostomy
  • Procedure: Supracolic gastrojejunal anastamosis
    Following resection in whipples pancreaticoduodenectomy, the gastrojejunal anastamosis is done in the supracolic compartment.
    Other Name: Supracolic and retrocolic gastrojejunostomy
  • Infracolic Anastamosis
    The gastrojejunal anastamosis is done in the infracolic compartment
    Intervention: Procedure: Infracolic gastrojejunal anastamosis
  • Supracolic Anastamosis
    The gastrojejunal anastamosis is done in the supracolic compartment
    Intervention: Procedure: Supracolic gastrojejunal anastamosis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
Same as current
March 2012
February 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients undergoing Whipples procedure

Exclusion Criteria:

  • Unresectable tumors at surgery
  • Postoperative mechanical obstruction
  • Postoperative mortality, where the test could not be done
Sexes Eligible for Study: All
Child, Adult, Older Adult
No
Contact information is only displayed when the study is recruiting subjects
India
 
 
NCT01191138
AIG-GIS-20090
Yes
Not Provided
Not Provided
Pradeep Rebala, Asian Institute of Gastroenterology
Asian Institute of Gastroenterology, India
KK Nuclear Scan
Principal Investigator: Pradeep Rebala, MS., M Ch Asian Institute of Gastroenterology
Asian Institute of Gastroenterology, India
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP