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CTRI Number  CTRI/2015/10/006325 [Registered on: 28/10/2015] Trial Registered Prospectively
Last Modified On: 28/10/2015
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia
Preventive 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A study to evaluate platelet rich plasma as a substance to facilitate easier removal of tumorous tissue from the intestine 
Scientific Title of Study   A randomized controlled study to evaluate autologous platelet rich plasma as an ideal substance for submucosal injection during endoscopic mucosal resection  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Palakurthy Murali Krishna 
Designation  Professor and Head, Department of Gastroenterology, Andhra Medical College 
Affiliation  Andhra Medical College 
Address  Department of Gastroenterology, Andhra Medical College, King George Hospital, Maharanipeta, Visakhapatnam 530002, Andhra Pradesh, India

Visakhapatnam
ANDHRA PRADESH
530002
India 
Phone  9032032000  
Fax    
Email  muralikrishna63@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Palakurthy Murali Krishna 
Designation  Professor and Head, Department of Gastroenterology, Andhra Medical College 
Affiliation  Andhra Medical College 
Address  Department of Gastroenterology, Andhra Medical College, King George Hospital, Maharanipeta, Visakhapatnam 530002, Andhra Pradesh, India


ANDHRA PRADESH
530002
India 
Phone  9032032000  
Fax    
Email  muralikrishna63@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Palakurthy Murali Krishna 
Designation  Professor and Head, Department of Gastroenterology, Andhra Medical College 
Affiliation  Andhra Medical College 
Address  Department of Gastroenterology, Andhra Medical College, King George Hospital, Maharanipeta, Visakhapatnam 530002, Andhra Pradesh, India


ANDHRA PRADESH
530002
India 
Phone  9032032000  
Fax    
Email  muralikrishna63@yahoo.com  
 
Source of Monetary or Material Support  
Department of Gastroenterology Andhra Medical College 
 
Primary Sponsor  
Name  Andhra Medical College 
Address  Department of Gastroenterology, Andhra Medical College, King George Hospital, Maharanipeta, Visakhapatnam 530002, Andhra Pradesh, India 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Palakurthy Murali Krishna  Andhra Medical College  Department of Gastroenterology, Andhra Medical College, King George Hospital, Maharanipeta, Visakhapatnam 530002, Andhra Pradesh, India
Visakhapatnam
ANDHRA PRADESH 
9032032000

muralikrishna63@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Andhra Medical College, Visakhapatnam  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Patients with sessile gastrointestinal polyps of diameter 1mm-20mm diagnosed by Upper gastrointestinal endoscopy or colonoscopy. ,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Sterile autologous platelet rich plasma  Platelet-rich plasma, contains a platelet concentration of at least 1,000,000 platelets/ µ L in 5 mL of plasma. It acts as a sub-mucosal cushion during gastro-intestinal polypectomy. It is associated with enhanced healing at the polypectomy site (site where Endoscopic Mucosal Resection has been performed). Autologous platelet rich plasma means that under strict asceptic conditions, a sample of platelet rich plasma is isolated from the blood of a participant and is used for gastro-intestinal submucosal injection through an endoscope below the polyp IN THE SAME INDIVIDUAL. 
Comparator Agent  Sterile normal saline  Normal saline is a solution of 0.90% w/v of NaCl, 308 mOsm/L or 9.0 g per liter. Sterile normal saline means the sample of normal saline to be used for gastrointestinal submucosal injection in the participant is obtained from a sterile normal saline pack and is injected submucosally through an endoscope under strict asceptic conditions.  
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1. Patients with sessile gastrointestinal polyps of diameter 1mm to 20mm diagnosed by Upper gastrointestinal endoscopy or colonoscopy will be included for the study.

2. If multiple polyps are present, only the largest sessile polyp (but less than or equal to 20 mm diameter) will be considered for the study. 
 
ExclusionCriteria 
Details  1. Age less than 20 years and age greater than 80 years

2. Pedunculated polyps

3. Sessile polyps less than 1 mm or greater than 20 mm in diameter

4. Lesions with ulceration

5.Friability

6. Non- lifting sign or lesions demonstrating deep submucosal invasion

7. Residual or recurrent lesion

8. Diagnosed case of inflammatory bowel disease

9. Coagulopathies

10. Cardiac pacemaker

11. Pregnant or lactating females

12. Patients who are on anti-coagulant drugs and anti-platelet drugs

13. Routine contraindications for gastrointestinal endoscopy 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To measure the en-bloc resection rate of gastrointestinal polyps in all the included study participants
En-bloc resection rates will be compared between the two study arms using percentages and proportions. Parametric and non-parametric data will be analyzed with suitable tests of significance. 
After the endoscopic procedure is completed 
 
Secondary Outcome  
Outcome  TimePoints 
To identify any post-procedural complications of ENdoscopic Mucosal Resection (EMR)  a. Immediately after EMR
b. After two weeks during a follow-up endoscopy or colonoscopy
 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   20/11/2015 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="10"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Endoscopic Mucosal Resection (EMR) is a proven technique for endoscopic removal of sessile gastrointestinal neoplasms. Administration of sub- mucosal injections has become a part and parcel of Endoscopic Mucosal Resection (EMR) to create a sub-mucosal cushion, to separate the sub-mucosa from the muscularis for en-bloc resection and for preventing complications like perforation and hemorrhage secondary to thermal injury. An ideal sub mucosal injection is one which maintains a long lasting mucosal elevation and which gives a hemi spherical shape to the mucosa for easy snaring. Many materials have been proposed for use as sub mucosal injections during EMR. They include saline, hypertonic dextrose water, glycerol, hyaluronic acid, sodium alginate, polymers, hydroxyl ethyl starch, fibrinogen, serum, plasma, and whole blood. Some materials are expensive whereas others can induce allergic reactions. Few others maintain the sub-mucosal elevation for a very short duration.

We hereby propose autologous Platelet Rich Plasma (PRP) as a possible substance that may fit most of the ideal submucosal injection characteristics. Platelets contain a number of proteins, cytokines, and other bioactive factors that initiate and regulate basic aspects of wound healing. Normal platelet counts in blood range from 150,000/ µ L to 350,000/ µ L. Plasma is the fluid portion of blood and contains clotting factors and other proteins and ions. Platelet-rich plasma contains a 3- to 5-fold increase in growth factor concentrations. Platelet concentration of at least 1,000,000 platelets/ µ L in 5 mL of plasma, is associated with the enhancement of healing. Platelet Rich Plasma may also contribute to longer duration of sub-mucosal elevation during polypectomy (EMR) which will aid the endoscopist in polypectomy.

This will be a randomized, outcome assessor blinded, active controlled, prospective study.

Patients with sessile gastrointestinal polyps of diameter 1mm to 20mm diagnosed by Upper gastrointestinal endoscopy or colonoscopy will be included for the study. After obtaining written informed consent from the eligible patients, he/ she will be randomized to the type of endoscopic sub-mucosal cushion to be used. For the subjects in Platelet Rich Plasma arm, twenty cc of blood will be drawn through an 18 gauge butterfly needle into two sterile vacutainers, each of ten cc capacity, pre-filled with Ethylene Di-amine Tetra Acetate (EDTA)- an anticoagulant. Acid Citrate Dextrose (ACD) will not be used as it has been proved that mean platelet volume is significantly lower values (6-13%, P< 0.05) in the citrated samples as compared to the same samples in EDTA. The blood will then be subjected to double centrifugation. Evidence advocates the better separation of platelets by double centrifugation.

Blood will not be drawn from the subjects in normal saline arm.

The patient will then be subjected to upper gastrointestinal endoscopy or colonoscopy based on the location of the lesion. After identifying the polyp and noting its approximate size, sub-mucosal cushion material will be injected in the sub-mucosa with a 21 gauge sclerotherapy needle by an assistant who is not a part of the study. Injection upto 5 ml of the material (either Normal Saline or Platelet Rich Plasma) will be permitted.

The following parameters will be noted:

a.Video of the sub-mucosal injection and the sub-mucosal elevation.

b.Time duration for the EMR procedure.

c.Whether the polypectomy was an en-bloc resection or a piece-meal resection.

Note: The duration of sub-mucosal elevation will not be noted. Making this observation will interfere with the EMR procedure as the primary outcome of the study is en-bloc resection rate and not mean duration of sub-mucosal elevation.

 

The resected polyp will be placed in 10% formaldehyde solution and will be sent for histo-pathological examination.

Follow-up endoscopy: 

Any post- procedural complications like bleeding, perforation etc will be noted immediately after the

EMR and after two weeks during a follow-up endoscopy/ colonoscopy. 

Statistical analysis:

En-bloc resection rates will be compared between the two study arms using percentages and proportions. Parametric and non-parametric data will be analyzed with suitable tests of significance.

 
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