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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  
Name  Address 
Nil  Nil 
 
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  
Status 
Not Applicable 
 
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.

 
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