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CTRI Number  CTRI/2025/09/094438 [Registered on: 09/09/2025] Trial Registered Prospectively
Last Modified On: 08/09/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   We looked at past records of patients who had surgery to remove part of their food pipe at a specialized cancer hospital in India. 
Scientific Title of Study   An Audit of Retrospective Database on Esophagectomy Surgeries at a Tertiary Care Cancer Hospital in India. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Swapnil Parab 
Designation  Professor 
Affiliation  Tata Memorial Centre, Parel, Mumbai 
Address  Department of Anaesthesiology, Critical Care and Pain, Tata Memorial Hospital, Dr Ernst Borges Road, Parel, Mumbai-12

Mumbai
MAHARASHTRA
400012
India 
Phone  9819319866  
Fax    
Email  swapnil.parab@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Swapnil Parab 
Designation  Professor 
Affiliation  Tata Memorial Centre, Parel, Mumbai 
Address  Department of Anaesthesiology, Critical Care and Pain, Tata Memorial Hospital, Dr Ernst Borges Road, Parel, Mumbai-12

Mumbai
MAHARASHTRA
400012
India 
Phone  9819319866  
Fax    
Email  swapnil.parab@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sargam Kant 
Designation  Fellow 
Affiliation  Tata Memorial Centre, Parel, Mumbai 
Address  Department of Anaesthesiology, Critical Care and Pain, Tata Memorial Hospital, Dr Ernst Borges Road, Parel, Mumbai-12

Mumbai
MAHARASHTRA
400012
India 
Phone  9167628811  
Fax    
Email  sargam.kant@gmail.com  
 
Source of Monetary or Material Support  
NIL 
Tata Memorial Hospital Dr.Ernst Borges Road, Parel, Mumbai-400012 
 
Primary Sponsor  
Name  Tata Memorial Hospital 
Address  Dr Ernst Borges Road, Parel, Mumbai-12 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
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 Sargam Kant  Tata Memorial Hospital  Dr Ernst Borges Road, Parel, Mumbai-400012
Mumbai
MAHARASHTRA 
9167628811

sargam.kant@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE, TATA MEMORIAL HOSPITAL  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  90.00 Year(s)
Gender  Both 
Details  ALL ADULT PATIENTS UNDERGOING ELECTIVE ESOPHAGECTOMY SURGERIES AT TMH 
 
ExclusionCriteria 
Details  Emergency surgeries
Inoperability after exploration
Performing any other procedure in addition to esophagectomy
Missing data  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To find out the incidence of postoperative complications (Clavein-Dindo 3a and above) till discharge across all types of esophagectomies performed at a single-centre tertiary care cancer hospital.  As we have a database of esophagectomy surgeries, the data will be assessed immediately after approval of registration. 
 
Secondary Outcome  
Outcome  TimePoints 
1. To determine the pre-operative & intraoperative factors that could contribute towards postoperative complications in esophagectomy surgeries.
2. To determine intraoperative sentinel events (arrhythmias, need for vasopressors; desaturation needing intervention).
3. To estimate the incidence of mortality in the postoperative period (until discharge).
4. Subset analysis for patients operated during the Coronavirus pandemic (March 2020-August 2021)
 
As this is an observational study with database present, data will be processed immediately after CTRI approval 
 
Target Sample Size   Total Sample Size="1140"
Sample Size from India="1140" 
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)   22/09/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  22/09/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="8"
Months="0"
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 - NO
Brief Summary  

Esophageal cancers account for the seventh most common type of cancer worldwide. ¹Esophagectomy is the modality of treatment for locally-advanced esophageal cancers in many patients. The ERAS guidelines strongly recommend smoking and alcohol abstinence, and low level of recommendation for investigations such as CPET. Nutrition is an important aspect in esophagectomy surgeries as many patients are malnourished, often requiring additional support. 2 There is moderate evidence that minimally invasive surgeries are associated with less blood loss, shorter hospital stay and reduced pain. ERAS guidelines also comment on optimum fluid administration and maintenance of normothermia. Intraoperatively, one-lung ventilation with permissible hypercapnia is strongly recommended. They also strongly recommend optimum pain management with thoracic epidural, paravertebral block and co-analgesics such as NSAID’s and acetaminophen.2

The Esophageal Complications Consensus group (ECCG) has provided a list of the most common complications occurring in esophagectomy surgeries that categorizes a wide range of potential complications, organized by the specific body system affected. These complications, which include issues like pneumonia and pleural effusions in the pulmonary system, cardiac arrest and dysrhythmias, gastrointestinal leaks and infections, and various other systemic problems, often require further medical intervention, prolonged hospital stays, or specialized management. 3 They also obtained prospective data for over 2700 patients across 24 centres in 14 countries over 2 years. 56.2% surgeries were performed in the distal esophagus with more than half of them receiving some form of treatment prior to surgery. The incidence of complications was found to be 59%, with pneumonia contributing 14.6% and anastomotic leak 14.5% The readmission rates were 11.2% and 30 and 90-day mortality rates were 2.4% and 4.5%, respectively. 4

Studies conducted across the globe aim at estimating the incidence of complications based on ECCG. Netherlands reported 65% of patients (1046 of 1617) with postoperative complications, with 29% (468 patients) experiencing a major complication. The most prevalent complications observed were pneumonia (21%), esophago-enteric leak from the anastomosis, staple line, or localized conduit necrosis (19%), and atrial dysrhythmia (15%). The associated 30-day mortality rate was 1.7%. 5  The Dutch Upper Gastrointestinal Cancer Audit also analysed 4096 patients and concluded that pulmonary complications and anastomotic leakage are the most impactful adverse events following surgery, significantly contributing to postoperative mortality (44.1% and 30.4% attributable risk, respectively), prolonged hospital stays (31.4% and 30.9% attributable risk) and hospital readmissions (7.3% and 14.7% attributable risk). Additionally, anastomotic leakage is the primary driver for reoperations, accounting for 47.1% of such instances. Other complications have a comparatively minor effect on these outcomes. 6 The main complications identified in a study in New Zealand spanning 25 years include POPC’s and anastomotic leaks. 7

Hence, we wanted conduct and audit based on the data at our centre as we conduct over 150 esophageal surgeries per year. This would help in improving the quality of treatment in such complex surgeries in India. This will be a single-centre audit of over 1000 patients who underwent elective esophagectomy from 2017-2024.

 
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