FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2019/05/018954 [Registered on: 06/05/2019] Trial Registered Prospectively
Last Modified On: 20/11/2019
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   To study the detection of metastatic disease by laparoscopy procedure and hence avoid surgical management of gastric cancer 
Scientific Title of Study   Impact of staging laparoscopy on operable gastric cancers- A prospective study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Chandramohan K 
Designation  Additional Professor 
Affiliation  Regional cancer center 
Address  Division of Surgical Oncology, Regional cancer center

Thiruvananthapuram
KERALA
695011
India 
Phone  9895774393  
Fax    
Email  drchandramohan@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Chandramohan K 
Designation  Additional Professor 
Affiliation  Regional cancer center 
Address  Division of Surgical Oncology, Regional cancer center

Thiruvananthapuram
KERALA
695011
India 
Phone    
Fax    
Email  drchandramohan@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Vijayasarathy S 
Designation  MCh Resident 
Affiliation  Regional cancer center 
Address  Division of Surgical Oncology, Regional cancer center

Thiruvananthapuram
KERALA
695011
India 
Phone  9176618802  
Fax    
Email  vijayasarathy1988@gmail.com  
 
Source of Monetary or Material Support  
Regional cancer center, Thiruvanthapuram 
 
Primary Sponsor  
Name  Regional cancer center 
Address  Thiruvananthapuram 
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 
Chandramohan  Regional cancer center  Division of surgical oncology, RCC
Thiruvananthapuram
KERALA 
9895774393

drchandramohan@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
HUMAN ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C169||Malignant neoplasm of stomach, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1.Newly diagnosed biopsy proven cases of locally advanced gastric adenocarcinoma defined as >cT2 and/or N+,M0
2. Patients fit for perioperative chemotherapy and surgery- ECOG:PS 0-2
3.Willing to give Informed consent 
 
ExclusionCriteria 
Details  1.Patients not treated with curative intent
2.Patients who have received some treatment outside.
3.Patients with synchronous malignancy
4.Patients presenting with obstruction, bleeding or perforation. 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Positive findings in staging laparoscopy  1 week after staging laparoscopy  
 
Secondary Outcome  
Outcome  TimePoints 
Morbidity and mortality associated with procedure
 
1 month after the procedure 
 
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)   06/05/2019 
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)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   nil 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  
  • Background:

    Staging laparoscopy is a valuable tool and a recommended technique for the staging of gastric cancer[1][2]. However there is no uniform consensus on indications for staging laparoscopy[3]. NCCN recommends in category 2B for a subset with T3/ N+, whereas ESMO guidelines give a III,B recommendation for all resectable gastric cancers. Considering surgical practice in India, a standard protocol is yet to be agreed upon[4].

    Aim:

    To investigate feasibility of staging laparoscopy prior to neoadjuvant chemotherapy in locally advanced gastric and OG junction cancers

    Objectives

    Primary:

    1.To know the role of staging Laparoscopy (SL) in locally advanced stomach and OG junction cancers

    Secondary:

    1.To study the morbidity and mortality associated with SL

    2. To study the pattern of positive findings and analyze risk factors (patient and disease related) associated with positive findings in SL

    3. To compare role of imaging with SL in detection of peritoneal metastasis

    Materials and methods:

    Study period:

    May 2018- May 2020

    Study setting: RCC, Trivandrum

    Inclusion Criteria:

    1.Newly diagnosed biopsy proven cases of locally advanced gastric adenocarcinoma defined as >cT2 and/or N+.

    2.Age 20-70 years

    3.Patients fit for perioperative chemotherapy and surgery-

    ECOG:PS 0-2

    4.Willing to give Informed consent

    Exclusion criteria:

    1.Patients who received some treatment outside.

    2.Patients with synchronous malignancy

    3.Patients unfit for laparoscopic procedure or general anesthesia

    4.Patients presenting with obstruction, bleeding or perforation.

    Methodology:

    Newly diagnosed cases of gastric adenocarcinoma presenting to RCC during the study period will be considered for the study. After taking informed consent, a detailed history and physical examination will be done. Demographic data will be acquired. The results of hematology, serum biochemistry, endoscopy and pathology will be recorded. At presentation contrast enhanced CT of chest and abdomen will be studied. If the disease is cT3/4 N0/+ M0 in the CT imaging, patients will undergo staging laparoscopy. Those patients with a localized operable disease in the laparoscopy and negative peritoneal washings will receive further treatment. (NACT followed by surgery). Patients with positive disease in SL will be put on palliation. All the data will be subjected to statistical analysis to obtain any significant results.

    Staging laparoscopy technique

    A 10mm trocar is inserted under direct vision along the anticipated laparotomy incision. Under 15 mmHg pressure pneumoperitoneum created and the abdomen is evaluated with a 30° angle laparoscope. The whole abdomen is inspected including the parietal and visceral peritoneum in every quadrant, the pelvis, the anterior and posterior surface of the liver, porta hepatitis, gastrohepatic omentum, duodenum, transverse mesocolon and celiac region. Typically, two additional 5 mm ports are necessary for exposure. The non regional lymph node areas and entire viscera of peritoneal cavity will be inspected. Any lesions likely to be metastases are sampled and analyzed by histopathology. Frozen section may be used for ensuring adequacy of biopsy. At least 100 ml of the fluid used for peritoneal washing will be aspirated and sent for cytological examination.

    Definition of ‘Positive SL’

    1) Ascites and/or Peritoneal disease (after positive biopsy/cytology) 2) Non-regional lymph node metastasis(eg. para-aortic lymph nodes) 3) Other metastatic deposits in abdomen

    Follow up:

    All patients subjected to SL will be followed up for 1 month and any morbidity or mortality will be recorded.

 
Close