| CTRI Number |
CTRI/2026/07/113935 [Registered on: 14/07/2026] Trial Registered Prospectively |
| Last Modified On: |
11/07/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Comparing Two Feeding Tube Methods to Improve Nutrition and Recovery after Stomach Cancer Surgery |
|
Scientific Title of Study
|
Nutritional Impact of Prophylactic Feeding Jejunostomy in Major Upper GI Cancer Surgery: A Prospective Cohort Study of 300 Patients |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Syed Nusrath |
| Designation |
Consultant, Surgical Oncology |
| Affiliation |
Basavatarakam Indo American Cancer Hospital and Research Institute |
| Address |
Department of surgical oncology, Basavatarakam Indo American Cancer Hospital and Research Institute, Road No 10, Banjara Hills, Hyderabad, Telangana, India 500034
Hyderabad
TELANGANA
500034
India |
| Phone |
9030747486 |
| Fax |
040-2354 2120 |
| Email |
dr.nusrath2008@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Syed Nusrath |
| Designation |
Consultant, Surgical Oncology |
| Affiliation |
Basavatarakam Indo American Cancer Hospital and Research Institute |
| Address |
Department of surgical oncology, Basavatarakam Indo American Cancer Hospital and Research Institute, Road No 10, Banjara Hills, Hyderabad, Telangana, India 500034
Hyderabad
TELANGANA
500034
India |
| Phone |
9030747486 |
| Fax |
040-2354 2120 |
| Email |
dr.nusrath2008@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Syed Nusrath |
| Designation |
Consultant, Surgical Oncology |
| Affiliation |
Basavatarakam Indo American Cancer Hospital and Research Institute |
| Address |
Department of surgical oncology, Basavatarakam Indo American Cancer Hospital and Research Institute, Road No 10, Banjara Hills, Hyderabad, Telangana, India 500034
Hyderabad
TELANGANA
500034
India |
| Phone |
9030747486 |
| Fax |
040-2354 2120 |
| Email |
dr.nusrath2008@gmail.com |
|
|
Source of Monetary or Material Support
|
| Basavatarakam Indo American Cancer Hospital and Research Insitute, Hyderabad, Telangana, India |
|
|
Primary Sponsor
|
| Name |
Basavatarakam Indo American Cancer Hospital and Research Institute |
| Address |
Basavatarakam Indo American Cancer Hospital and Research Institute, Road No 10, Banjara Hills, Hyderabad, Telangana, India 500034 |
| 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 |
| Syed Nusrath |
Basavatarakam Indo American Cancer Hospital and Research Institute |
Room no 2, OT complex, 4th Floor, Block no 1
Hyderabad
TELANGANA |
9030747486
dr.nusrath2008@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics committe of Basavatarakam Indo American Cancer Hospital and Research Institute |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Prophylactic Feeding Jejunostomy |
Patients undergoing curative major upper gastrointestinal cancer surgery will receive prophylactic feeding jejunostomy placement during surgery
Wieght monitoring weekly till 3 months serum albumin every 2 weekly till 3 months
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Age 18 to 75 years
Histologically confirmed upper gastrointestinal malignancy
Patients scheduled for curative-intent major upper GI oncologic surgery such as esophagectomy gastrectomy or pancreatoduodenectomy with planned prophylactic feeding jejunostomy placement
ECOG performance status 0 to 2
Ability and willingness to provide written informed consent |
|
| ExclusionCriteria |
| Details |
Patients undergoing palliative surgery only
Patients with pre-existing enteral feeding access eg PEG or jejunostomy
Known allergy or hypersensitivity to jejunostomy tube materials
Expected survival less than 3 months due to advanced disease or severe comorbidities
Pregnant patients |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Absolute change in body weight in kgs from preoperative baseline to 3 months after surgery in patients undergoing major upper gastrointestinal cancer surgery with prophylactic feeding jejunostomy |
at baseline and at 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Mean change in serum albumin levels from baseline to 3 months |
At baseline
At 2 weeks
At 4 weeks & at 3 months postoperatively |
| Incidence & type of FJ related complications graded according to Clavien Dindo classification |
Within 3 months after surgery |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
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)
|
01/09/2026 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Malnutrition is common in patients undergoing major upper gastrointestinal cancer surgery and can negatively affect postoperative recovery and long-term outcomes. Prophylactic feeding jejunostomy (FJ) is frequently placed during surgery to provide early enteral nutrition; however, detailed prospective data on postoperative nutritional recovery in these patients remain limited. This prospective single-center observational cohort study aims to evaluate the nutritional impact of prophylactic feeding jejunostomy in patients undergoing major upper gastrointestinal cancer surgery. A total of 300 consecutive patients undergoing curative surgery such as esophagectomy, gastrectomy, or pancreatoduodenectomy with planned prophylactic FJ placement will be enrolled. The primary outcome is the change in body weight from preoperative baseline to 3 months after surgery. Secondary outcomes include changes in serum albumin levels, the proportion of patients experiencing significant weight loss, postoperative complications, feeding jejunostomy–related complications, and hospital outcomes. Patients will be followed with scheduled weight and laboratory assessments for 3 months after surgery to characterize postoperative nutritional recovery and identify factors associated with poor nutritional outcomes. |