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CTRI Number  CTRI/2025/11/096787 [Registered on: 03/11/2025] Trial Registered Prospectively
Last Modified On: 31/10/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Single Arm Study 
Public Title of Study   Study on using omentum (Fat tissue near stomach) to encircle the new junction between the remanant food pipe and stomach in the neck after removal of the foor pipe for cancer, in order to improve postoperative healing and reduce Complications. 
Scientific Title of Study   OMentum Around Neck Anastomosis (OMANA) trial- A phase II, prospective, single-arm interventional trial of omental wrapping around cervical esophagogastric anastomosis after esophagectomy 
Trial Acronym  OMANA 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Karthik V 
Designation  ASSOCIATE PROFESSOR THORACIC ONCOLOGY E 
Affiliation  Tata Memorial Hospital 
Address  HBB 301 3rd Floor Tata memorial Hospital DR E Borges Marg Parel Mumbai
Tata memorial Hospital DR E Borges Marg Parel Mumbai 400012 India
Mumbai (Suburban)
MAHARASHTRA
400012
India 
Phone  7738922377  
Fax    
Email  karthik290389@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Karthik V 
Designation  ASSOCIATE PROFESSOR THORACIC ONCOLOGY E 
Affiliation  Tata Memorial Hospital 
Address  HBB 301 3rd Floor Tata memorial Hospital DR E Borges Marg Parel Mumbai
Tata memorial Hospital DR E Borges Marg Parel Mumbai 400012 India
Mumbai (Suburban)
MAHARASHTRA
400012
India 
Phone  7738922377  
Fax    
Email  karthik290389@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Karthik V 
Designation  ASSOCIATE PROFESSOR THORACIC ONCOLOGY E 
Affiliation  Tata Memorial Hospital 
Address  HBB 301 3rd Floor Tata memorial Hospital DR E Borges Marg Parel Mumbai
Tata memorial Hospital DR E Borges Marg Parel Mumbai 400012 India
Mumbai (Suburban)
MAHARASHTRA
400012
India 
Phone  7738922377  
Fax    
Email  karthik290389@gmail.com  
 
Source of Monetary or Material Support  
Tata Memorail hospital  
 
Primary Sponsor  
Name  Tata Memorial Hospital  
Address  TATA MEMORIAL HOSPITAL Dr E Borges Road Parel Mumbai 400012 India 
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 Karthik V  Tata Memorial Hospital  HBB Block, Room No 301, 302 Department Of Surgical Oncology Dr E borges Road, Parel, Mumbai-400012
Mumbai (Suburban)
MAHARASHTRA 		 7738922377
--
karthik290389@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE II  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C390||Malignant neoplasm of upper respiratory tract, part unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  McKeown total esophagectomy with cervical esophagogastic anastomosis  Eligible and recruited Patients will undergo thoracic esophageal mobilization after conforming operability either through thoracotomy or thoracoscopy or robotic approach. A 2 field or 3 field lymphadenectomy will be done as decided in the tumor board. After completion of the thoracic part, patient will be made supine, the stomach mobilized from adjacent structures either through open or minimally invasive approach, while mobilizing the greater omentum, a tongue of omentum measuring 4 to 5 cm near the terminal part of right gastro epiplioic vessel until just beyond the left gastro epiplioc vessel is taken along. The esophagus is divided in the left neck and specimen delivered out. A gastric conduit is fashioned using a stapler. The vascularised tongue of omentum attached to the cranial end of the conduit is firmly anchored to the tip of the conduit and delivered to the neck. A stapled or hybrid esophagogastric anastomosis is performed and the tongue of the omentum loosely wrapped around the anastomosis and tagged using sutures. The procedures will be performed by or under supervision of 5 thoracic surgeons in the unit who have performed more than 50 esophagogastric anastomosis. Patients with a clinical suspicion of leak (assessed by the treating surgeon) will undergo a contrast enhanced computed tomography. If found to have an anastomotic leak will undergo further management as deemed appropriate by the treating clinician.The duration needed for this intervention is expected to be around 10 minutes during the surgery, however it will be a permanent procedure once performed 
Comparator Agent  Not Applicable  Not Applicable 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Patients undergoing McKeown esophagectomy with a stapled and or hybrid and or handsewn anastomosis in the neck

Written informed consent form 
 
ExclusionCriteria 
Details  Retrosternal route of reconstruction

Conduits other than stomach

Previous gastric, pancreatic, colonic or splenic surgery that would have violated the omentum 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Proportion of patients with anastomotic leak, defined as full thickness gastro intestinal defect involving esophagus, anastomosis, staple line, or conduit irrespective of presentation or method of detection as set by ECCG (Esophagectomy complications consensus group), identified clinically/radiologically. This will be analysed in the intent to treat as well as per protocol populations  At the time of surgery  
 
Secondary Outcome  
Outcome  TimePoints 
Mean Intraoperative blood loss  After surgery 
Median Duration of surgery
 		 After surgery 
Incidence of major postoperative complication as defined by Clavien Dindo classification (CD greather than II)
 		 After surgery 
30-day post operative mortality expressed as a percentage  After Surgery 
90-day post-operative mortality expressed as a percentage
 		 After Surgery 
90 day anastomotic stricture rates expressed as a percentage(patients presenting with symptom of dysphagia at follow up within 90 days will be subjected to a esophagogastroduodenoscopy to assess for anastomotic stricture)
 		 After surgery 
 
Target Sample Size   Total Sample Size="76"
Sample Size from India="76" 
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   Phase 2 
Date of First Enrollment (India)   17/11/2025 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
Surgery for food pipe (esophageal) cancers involves removal of the food pipe along with the tumor in the chest and re establishment of bowel continuity by joining the remanent food pipe and stomach in the neck. This new junction is at high risk of anastomotic leakage in the post operative period, which causes significant suffering to the patient and increases the risk of death. Omentum is the fat that is attached to the stomach which is shown to be rich in blood supply and has been previously used in various gastro intestinal surgeries to augment anastomosis or repair any leaks. This technique has been tried prior in smaller studies with fewer patients undergoing esophagectomy. We aim to perform a single arm prospective trial of omental wrapping around the new junction in the neck after esophagectomy and its effect on post operative anastomotic leaks.
 
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