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CTRI Number  CTRI/2026/01/100146 [Registered on: 01/01/2026] Trial Registered Prospectively
Last Modified On: 24/06/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Single Arm Study 
Public Title of Study   Outcomes of Stapled Cervical Anastomosis After Esophagectomy for Esophageal cancer 
Scientific Title of Study   Clinical Outcomes of Total Mechanical Cervical Esophago-Gastric Anastomosis After Mckeown Esophagectomy for Esophageal cancer – A Prospective Observational Study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mahesh Kumar 
Designation  Senior Resident 
Affiliation  AIIMS Jodhpur  
Address  Department of Surgical Gastroenterology, All India Institute of Medical Sciences Basni Industrial Area, Phase 2, Jodhpur, Rajasthan

Jodhpur
RAJASTHAN
342005
India 
Phone  7651851394  
Fax    
Email  drkumarmahesh2506@gmail.com   
 
Details of Contact Person
Scientific Query  
Name  Dr Selvakumar B  
Designation  Associate professor  
Affiliation  AIIMS Jodhpur  
Address  Department of Surgical Gastroenterology, All India Institute of Medical Sciences Basni Industrial Area, Phase 2, Jodhpur, Rajasthan

Jodhpur
RAJASTHAN
342005
India 
Phone  8004502603  
Fax    
Email  selvasriram87@gmail.com   
 
Details of Contact Person
Public Query  
Name  Mahesh Kumar 
Designation  Senior Resident 
Affiliation  AIIMS Jodhpur  
Address  Department of Surgical Gastroenterology, All India Institute of Medical Sciences Basni Industrial Area, Phase 2, Jodhpur, Rajasthan


RAJASTHAN
342005
India 
Phone  7651851394  
Fax    
Email  drkumarmahesh2506@gmail.com   
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences (AIIMS), Basni Industrial Area phase II, Jodhpur - 342005 (Rajasthan) 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences AIIMS 
Address  Basni Industrial Area, Phase 2, Jodhpur - 342005 (Rajasthan) 
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 
Dr Mahesh Kumar  All India Institute Of Medical Sciences, Jodhpur  Department of Surgical Gastroenterology, 5th Floor, C block, Room No.-549 AIIMS, Basni Industrial Area, Phase-II, Jodhpur RAJASTHAN
Jodhpur
RAJASTHAN 		 7651851394

drkumarmahesh2506@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C159||Malignant neoplasm of esophagus, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Patient who undergo Mckeown esophagectomy for carcinoma esophagus  
 
ExclusionCriteria 
Details  Prior gastric resections/conduits other than stomach
Undergoing second stage reconstruction  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Post-operative anastomotic leak  within 30 days of surgery  
 
Secondary Outcome  
Outcome  TimePoints 
1.Initiation of oral intake
2.Post-operative hospital stay
3.Post-operative pulmonary complication
4. Mortality
5. Anastomotic stricture  		 1. Post-operative day of event
2. Post-operative day of event
3. Post-operative day of event
4. Post-operative day of event upto 90 days
5. Occurence of event at 180 days 
 
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)   11/01/2026 
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="1"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response (Others) -  Reasonably justified request to email of PI

  6. For how long will this data be available start date provided 01-01-2025 and end date provided 30-12-2030?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Cervical esophago-gastric anastomosis (CEGA) leak post Mc-Keown esophagestomy is 22.2%. Factors influencing incidence of anastomotic leak are patient related factors like BMI, Tumor stage, Nutritional status and Surgical factors like stapled anastomosis, hand sewn anastomosis, intraoperative blood loss. In this study i want to know the incidence rate of anastomotic leak in total mechanical Cervical esophago-gastric anastomosis in Indian population.  
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