| 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
|
|
|
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
|
|
|
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. |