| CTRI Number |
CTRI/2026/02/102896 [Registered on: 03/02/2026] Trial Registered Prospectively |
| Last Modified On: |
03/02/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
How Patients with Rare Pancreatic Tumors (SPEN) Do after Surgery: Survival, Recovery, and Complications |
|
Scientific Title of Study
|
Clinical outcomes of Solid Pseudopapillary Epithelial Neoplasms (SPEN) of the Pancreas after Surgical Resection: A retrospective multicenter cohort study |
| 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 Manish Bhandare |
| Designation |
Professor and Surgeon |
| Affiliation |
Tata Memorial Centre |
| Address |
263, 2nd floor, HPB UGI Surgical Department, Paymaster Shodhika Building ACTREC Sector 22 Utsav Chowk CISF Rd Owe Camp Kharghar Navi Mumbai Maharashtra 410210
Mumbai MAHARASHTRA 410210 India |
| Phone |
07738389116 |
| Fax |
|
| Email |
manishbhandare@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Manish Bhandare |
| Designation |
Professor and Surgeon |
| Affiliation |
Tata Memorial Centre |
| Address |
263, 2nd floor, HPB UGI Surgical Department, Paymaster Shodhika Building ACTREC Sector 22 Utsav Chowk CISF Rd Owe Camp Kharghar Navi Mumbai Maharashtra 410210
MAHARASHTRA 410210 India |
| Phone |
07738389116 |
| Fax |
|
| Email |
manishbhandare@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Manish Bhandare |
| Designation |
Professor and Surgeon |
| Affiliation |
Tata Memorial Centre |
| Address |
263, 2nd floor, HPB UGI Surgical Department, Paymaster Shodhika Building ACTREC Sector 22 Utsav Chowk CISF Rd Owe Camp Kharghar Navi Mumbai Maharashtra 410210
MAHARASHTRA 410210 India |
| Phone |
07738389116 |
| Fax |
|
| Email |
manishbhandare@gmail.com |
|
|
Source of Monetary or Material Support
|
| Infrastructure Support Tata Memorial Centre : Dr. E Borges Marg, Parel Mumbai India 400012 |
|
|
Primary Sponsor
|
| Name |
Tata Memorial Centre |
| Address |
Tata Memorial Hospital Dr E Borges Marg Parel Mumbai MAHARASHTRA 400012 India
AND
ACTREC Tata Memorial Centre Sector 22 Utsav Chowk CISF Rd Owe Camp Kharghar Navi Mumbai Maharashtra 410210 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
Taiwan Thailand Viet Nam Australia Bangladesh China Hong Kong India Japan Malaysia Nepal New Zealand Philippines Republic of Korea Singapore Italy |
|
Sites of Study
|
| No of Sites = 15 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Pradeep Rebala |
AIG Hospitals and Asian Institute of Gastroenterology |
Department of Surgical Gastroenterology, No 1 66AIG2 to 5, Mindspace Road, P Janardhan Reddy Nagar, Gachibowli, Hyderabad, Telangana, 500032 Hyderabad TELANGANA |
9866148661
pradeep.rebala@gmail.com |
| Amit Gupta |
All India Institute of Medical Sciences Rishikesh |
016311 6th Level Dept of Surgery and Surgical Oncology
Medical College Block
All India Institute of Medical Sciences Rishikesh Uttarakhand 249203 Dehradun UTTARANCHAL |
9891981331
dramit2411@gmail.com |
| Puneet Dhar |
Amrita Hospital |
Sixth Floor, Amrita Hospital, 6207, Mata Amritanandamayi Marg, RPS City, Sector 88, Faridabad, Haryana 121014 Faridabad HARYANA |
9447736769
dharpuneet@gmail.com |
| Dr P Jagannath |
Continental Cancer centre Hyderabad |
Department of Surgical Oncology, Plot No. 3, Road No. 2, IT Park, Nanakramguda, Gachibowli, Hyderabad, Telangana 500032, India Hyderabad TELANGANA |
9820086797
drjagannath@gmail.com |
| Jeswanth Satyanesan |
Govt Stanley Medical College, Chennai |
Division of HPB, Institute of Surgical Gastroenterology & Liver Transplantation,
Government Stanley Medical College & Hospital,
Old Jail Road, Chennai - 600001,Tamil Nadu, India. Chennai TAMIL NADU |
9444357682
drjeswanth@yahoo.co.in |
| Nagesh N S |
IGOT, Bangalore |
Department of Surgical Gastroenterology, Victoria Hospital Campus, New Tharagupet, Bengaluru, Karnataka 560002 Bangalore KARNATAKA |
9448203196
drnageshns@gmail.com |
| Kalayarasan |
Jawaharlal Institute of Post Graduate Medical Education and Research JIPMER |
Room no 5442, Department of Surgical Gastroenterology
Fourth Floor, Superspecialty Block,
Jawaharlal Institute of Post Graduate Medical Education and Research (JIPMER),
Dhanvantry Nagar, Gorimedu
Puducherry - 605006 Pondicherry PONDICHERRY |
9843015499
kalayarasanraja@yahoo.com |
| H Ramesh |
Lakeshore hospital and Research Center |
16 612,Department of Surgical Gastroenterology
Lakeshore Hospital,
NH Bypass, Nettoor, Cochin 682040 Ernakulam KERALA |
9447040368
drhramesh@gmail.com |
| Adarsh Chaudhary |
Medanta Hospital |
The Department of GI Surgery, GI Oncology, and Bariatric Surgery, Medanta The Medicity, Regulatory office, II nd Floor, Opposite Medical
Library, Training Block, , Sector- 38, Gurgaon 122001 Gurgaon HARYANA |
9810301847
adarsh_chaudhary@yahoo.com |
| Ravi Shankar Biswas |
Medical college hospital, Kolkata |
Room 5001, Department of Surgical Gastroenterology
Super Speciality Block
Medical College Hospital
88, College Street, College Square
Kolkata 700073 Kolkata WEST BENGAL |
9874338353
drrsbiswas1@gmail.com |
| VK Kapoor |
MGMCH Jaipur |
RIICO Institutional Area, Mahatma Gandhi Rd, Ricco Industrial Area, Sitapura, Jaipur, Ramchandpura, Rajasthan 302022 Jaipur RAJASTHAN |
8004204751
vkkapoor.india@gmail.com |
| Rajesh Gupta |
PGIMER, Chandigarh |
R no 23, 5th Floor, Faculty office, Department of GI Surgery, HPB and Liver Transplantation, Postgraduate Institute of Medical Education and Research, Sector 12, Chandigarh 160012 Chandigarh CHANDIGARH |
9216512636
rajsarakshi@gmail.com |
| Sadiq Sikora |
Sakra Hospital |
SY NO 52 2 and 52 3, Devarabeesanahalli, Varthur Hobli Opp Intel, Outer Ring Rd, Marathahalli, Bengaluru, Karnataka 560103 Bangalore KARNATAKA |
9900504360
drsadiqs@gmail.com |
| Chetan Kantharia |
Seth GS Medical College and KEM Hospital, Mumbai India |
New Multi-Storied Building, 2nd Floor Ward 43, Department Of Surgical Gastroenterology, Seth GS Medical College and KEM Hospital, Acharya Dhonde Marg, Parel, Mumbai-400012 Mumbai MAHARASHTRA |
9869072625
kanthariachetan@gmail.com |
| Dr Manish Bhandare |
Tata Memorial Centre |
325, 3rd floor Homibhabha Building, Department of Surgical Oncology, Tata Memorial Hospital
Dr. E Borges Marg, Parel,
Mumbai, INDIA
and
263, 2nd floor, HPB UGI Surgical Department, Paymaster Shodhika Building ACTREC Sector 22 Utsav Chowk CISF Rd Owe Camp Kharghar Navi Mumbai Maharashtra 410210 Mumbai MAHARASHTRA |
07738389116
manishbhandare@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 15 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Submittted/Under Review |
| Institutional Ethics Committee |
Submittted/Under Review |
| AIG Institutional Ethics Committee |
Submittted/Under Review |
| Ethics Committee |
Submittted/Under Review |
| Institutional Ethics Committee |
Submittted/Under Review |
| Institutional Ethics Committee |
Submittted/Under Review |
| Institutional Ethics Committee |
Submittted/Under Review |
| Institutional Ethics Committee |
Submittted/Under Review |
| INSTITUTIONAL ETHICS COMMITTEE FOR HUMAN RESEARCH |
Submittted/Under Review |
| Institutional Ethics Committee IEC-I) |
Submittted/Under Review |
| JIPMER Institutional Ethics Committee |
Submittted/Under Review |
| Lakeshore Ethics Committee |
Submittted/Under Review |
| Medanta Institutional Ethics Committee MIEC |
Submittted/Under Review |
| Sakra World Hospital Ethics Committee |
Submittted/Under Review |
| Tata Memorial Hospital Institutional Ethics Committee I |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C259||Malignant neoplasm of pancreas, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. All patients with final histology proven SPEN who underwent surgery.
2. The period for recruitment is January 2007 to Dec 2024
3. Patients who were deemed inoperable during surgical exploration will also be included in the
study. |
|
| ExclusionCriteria |
| Details |
1. Final histology not suggestive of SPEN
2. Date of surgery outside of study protocol
3. Incomplete case records |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Overall survival and disease-free survival after surgical resection of SPEN. |
5 years after surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Short-term oncological results and postoperative complication rates. |
From date of surgery to 90 days post-surgery |
|
|
Target Sample Size
|
Total Sample Size="2000" 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)
|
02/03/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
16/03/2026 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2" 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
|
Solid pseudopapillary epithelial neoplasm (SPEN) is a rare type of pancreatic tumor, accounting for only 0.2 to 2.7 percent of all pancreatic cancers. It mostly affects young women and typically grows slowly, although in some cases it can behave aggressively and spread. SPENs are often discovered by accident during scans for other health issues, but some people experience symptoms like abdominal pain, nausea, or weight loss. Surgery is the main treatment for SPEN and offers the only potential cure. However, the type and complexity of surgery can vary based on the tumor’s size, location in the pancreas, and whether it has spread. Chemotherapy and radiation are not usually effective for this kind of tumor. This research project is a large, international, retrospective study involving multiple hospitals across the Asia-Pacific region. It will analyze data from patients who underwent surgery for SPEN between 2007 and 2024. The study aims to better understand surgical outcomes and identify factors that affect long-term survival. Researchers will look at post-operative complications, tumor removal success, and how long patients live without the disease returning. The ultimate goal is to gather more data to help improve the treatment and prognosis of SPEN patients in the future. Since this is a retrospective study using past patient records, there is no additional risk or treatment for participants. All data will be kept confidential and securely stored. |