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CTRI Number  CTRI/2020/05/025445 [Registered on: 29/05/2020] Trial Registered Prospectively
Last Modified On: 23/04/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparing surgically placed jejunal tubes with nasal tubes for feeding in patients undergoing surgery for food pipe cancer. 
Scientific Title of Study   Comparing feeding jejunostomy with nasojejunal tube placement in patients undergoing oesophagectomy: A pilot study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Lokesh Agarwal 
Designation  MCh Resident 
Affiliation  AIIMS, New Delhi 
Address  Department of GI surgery and Liver Transplantation, Ansari Nagar, AIIMS New Delhi-110029

New Delhi
DELHI
110029
India 
Phone  9910499609  
Fax    
Email  devloksang@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Nihar Ranjan Dash 
Designation  Professor 
Affiliation  AIIMS, New Delhi 
Address  Department of GI surgery and Liver Transplantation, Ansari Nagar, AIIMS New Delhi-110029

New Delhi
DELHI
110029
India 
Phone  9868115535  
Fax    
Email  nagranjan@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Lokesh Agarwal 
Designation  MCh Resident 
Affiliation  AIIMS, New Delhi 
Address  Department of GI surgery and Liver Transplantation, Ansari Nagar, AIIMS New Delhi-110029

New Delhi
DELHI
110029
India 
Phone  9910499609  
Fax    
Email  devloksang@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences, New Delhi 
 
Primary Sponsor  
Name  None 
Address  Nil 
Type of Sponsor  Other [Nil] 
 
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 Lokesh Agarwal  AIIMS, New Delhi  Room no 1007, Department of GI Surgery and Liver transplant, AIIMS
New Delhi
DELHI 		 9910499609

devloksang@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee for Post Graduate Research  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  Nasojejunal tube  Tube inserted through nose into jejunum intraoperatively. Frequency: 1 tube per patient, randomized to nasojejunal tube placement. Duration of use: Removed 2 days after commencing oral feeds. 
Comparator Agent  Surgical feeding jejunostomy  Tube inserted into jejunum directly intraoperatively and fixed to anterior abdominal wall. Frequency: 1 tube per patient randomized to surgical feeding jejunostomy placement. Total duration: Minimum of 6 weeks after surgery 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  All patients undergoing oesophagectomy for carcinoma oesophagus. 
 
ExclusionCriteria 
Details  1.Those who refuse consent to participate in the study
2.Patients with any nasopharyngeal or oropharyngeal obstruction preventing insertion of nasojejunal tube
 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Rate of complications in both groups of patients: those undergoing nasojejunal tube feeding versus surgical feeding jejunostomy  Post operatively, till the time of removal of feeding jejunostomy tube at 6 weeks. 
 
Secondary Outcome  
Outcome  TimePoints 
1. To compare catheter efficacy of nasojejunal tube feeding with surgical feeding jejunostomy in terms of:
Time to full establishment of oral intake
Time to removal of feeding tube
 		 Postoperatively 
2. To compare the discomfort associated with surgical feeding jejunostomy versus nasojejunal tube using the visual analogue scale.  From post operative day 2 till the time of removal of nasojejunal tube 
3.To compare the quality of life with a surgical feeding jejunostomy with nasojejunal feeding tube using the WHOQOL-BREF questionnaire  Self reported at the time of discharge and at 6 weeks follow up.  
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   30/05/2020 
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="1"
Months="6"
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  

Early enteral nutrition is one of the key goals and is preferred over parenteral nutrition following oesophagectomy. It improves postoperative outcomes by maintaining gut mucosal integrity and improving immunological functioning. Feeding jejunostomy as a means of enteral access is being used routinely at many centres, but is associated with complications. Nasojejunal tube feeding is an alternative access route to establish enteral nutrition. There has been only one randomized control trial in patients with oesophageal cancer, in a western population, comparing feeding jejunostomy with nasojejunal tube feeding. There exists a paucity of studies in the Asian population, evaluating the safety and efficacy of nasojejunal tube feeding. We aim to compare feeding jejunostomy with nasojejunal tube feeding in terms of efficacy and complications in Indian patients undergoing gastric/colonic pull-up and cervical oesophageal anastomosis for carcinoma oesophagus.

 
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