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CTRI Number  CTRI/2020/06/025627 [Registered on: 05/06/2020] Trial Registered Prospectively
Last Modified On: 04/06/2020
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Prospective 
Study Design  Other 
Public Title of Study   To analyse the lymph node involvement pattern in large intestine cancer after surgery and correlate with different clinical and pathological parameters for better surgical outcomes. 
Scientific Title of Study   A prospective study on lymph nodal harvest in fresh, non-fixed, wet specimen of colonic malignancy. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Chandramohan K 
Designation  Additional Professor 
Affiliation  Regional Cancer Centre, Thiruvananthapuram 
Address  Division of Surgical oncology, 4th floor Regional cancer centre Trivandrum Kerala India Pin 695011

Thiruvananthapuram
KERALA
695011
India 
Phone  9895774393  
Fax    
Email  drchandramohan@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Chandramohan K 
Designation  Additional Professor 
Affiliation  Regional Cancer Centre,Thiruvananthapuram 
Address  Division of surgical oncology, 4th floor, Regional cancer centre Trivandrum Kerala India Pin 695011

Thiruvananthapuram
KERALA
695011
India 
Phone  9895774393  
Fax    
Email  drchandramohan@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Sandeep kumar Behera 
Designation  Mch resident 
Affiliation  Regional Cancer Centre,Thiruvananthapuram 
Address  Division of surgical oncology, 4th floor, Regional cancer centre Trivandrum Kerala India Pin 695011

Thiruvananthapuram
KERALA
695011
India 
Phone  9438211705   
Fax    
Email  sandeeprcc2018@gmail.com  
 
Source of Monetary or Material Support  
Regional Cancer Centre, Division of surgical oncology Trivandrum,Kerala 695011 
 
Primary Sponsor  
Name  Regional Cancer Centre 
Address  Trivandrum Kerala,India Pin - 695011 
Type of Sponsor  Research institution and hospital 
 
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 
Dr Chandramohan K  Regional Cancer Centre  Trivandrum
Thiruvananthapuram
KERALA 		 9895774393

drchandramohan@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Human Ethics committee, Regional Cancer Centre  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C189||Malignant neoplasm of colon, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Colectomy  Different types of colectomy according to the site of colonic malignancy. 
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Patients with biopsy proven adenocarcinoma of colon who undergo curative surgery in the division of surgical oncology,RCC. 
 
ExclusionCriteria 
Details  1. All emergency cases where the patient presented with obstruction.
2. Patient with past/present history of treatment for other cancer.
3. Patient who undergo palliative resection.
4. Patient with multiple cancer in colon. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. To evaluate and calculate the lymphnode harvest rate in fresh specimen of colonic cancer.
2. To know the pattern of lymphnode spread in various location and T stage of primary colonic cancer. 		 2 years 
 
Secondary Outcome  
Outcome  TimePoints 
To investigate clinicopathological factors that influence lymphnodal yield.  2years 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   30/06/2020 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

BACKGROUND OF STUDY

Colo-rectal adenocarcinoma is one of the most common malignant tumors world wide .

In non metastatic colorectal malignancies, one of the most important  prognostic factors is the number of lymph nodes ( NLN) examined in the pathological specimen whether positive or negative and it correlates closely with the survival of the patient.

When performing mesorectal and mesocolic excision for rectal and colon cancer, it is crucial to encompass the draining nodal basins for staging and, possibly, therapeutic purposes.

Guidelines recommended a cut off of 12 lymph nodes harvested is considered adequate.yet the evidence for such is questionable as it is unclear whether an increasing the LN count results in improved survival.

A better focus of guidelines and communication between pathologist and surgeon is a main determinant of  rise in NLN

The pursuit of a sufficient LN harvest represents good clinical  practice; however, recent evidence shows that the exhaustive searching for very high LN yields may be unnecessary and has little influence on modern approaches to treatment.


STUDY SETTING: Regional Cancer Centre, Trivandrum.

STUDY POPULATION:Patients undergoing colectomy in RCC for biopsy proven adenocarcinoma of colon .

SAMPLE SIZE

50 cases

PERIOD OF STUDY: 2 Year

METHODOLOGY

Specimen  is collected in the operating room immediately following surgery.

The same is examined before immersing into the formalin.

Dissection of the specimen is done in the presence of a pathologist to retrieve the lymph nodes from the specimen.

Visual and palpatory method is used for identification of the nodes.

The lymph node stations are harvested and numbered using Japanese Society of Colorectal Cancer Classification.

Lymph nodes are mounted on a pre prepared chart to label their location/station.


STATISTICAL ANALYSIS

The number of node positivity among the total number of nodes retrieved.

The number of LNs examined per patient will be the main endpoint of interest. Mean and median numbers of LNs examined according to individual patient characteristics will be estimated for patients with colon cancer . Poisson regression will be used to model the number of LNs retrieved as a function of pathological and clinical factors( age, sex, tumor stage,grade and location) and to identify significant predictors of LN retrieval. Regression coefficients in Poisson regression are log‐risk ratios and, thus, are useful for interpretation.

References

  • 1. Compton CC, Fielding LP, Burgart LJ, Conley B, Cooper HS, Hamilton SR, Hammond ME, Henson DE, Hutter RV, Nagle RB, et al. Prognostic factors in colorectal cancer. College of American Pathologists Consensus Statement 1999. Arch Pathol Lab Med. 2000;124:979–994.

    2.   Baxter NN, Virnig DJ, Rothenberger DA, Morris AM, Jessurun J, Virnig BA. Lymph node evaluation in colorectal cancer patients: a population-based study. J Natl Cancer Inst. 2005;97:219–225.

    3.   O’Dwyer ST, Haboubi NY, Johnson JS, Gardy R. Detection of lymph node metastases in colorectal carcinoma. Colorectal Dis. 2001;3:288–294.

    4.Le Voyer TE, Sigurdson ER, Hanlon AL, Mayer RJ, Macdonald JS, Catalano PJ, Haller DG. Colon cancer survival is associated with increasing number of lymph nodes analyzed: a secondary survey of intergroup trial INT-0089. J Clin Oncol. 2003;21:2912–2919.

    5.  Tsai HL, Lu CY, Hsieh JS, Wu DC, Jan CM, Chai CY, Chu KS, Chan HM, Wang JY. The prognostic significance of total lymph node harvest in patients with T2-4N0M0 colorectal cancer. J Gastrointest Surg. 2007;11:660–665.



 
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