| CTRI Number |
CTRI/2025/08/093630 [Registered on: 25/08/2025] Trial Registered Prospectively |
| Last Modified On: |
25/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
MORIP: An international study looking at major cancer surgeries that involve removing the pancreas along with nearby organs |
|
Scientific Title of Study
|
Multivisceral Oncological Resections Involving the Pancreas An International Multicenter Study MORIP AIMS |
| Trial Acronym |
MORIP AIMS |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shailesh Shrikhande |
| Designation |
Deputy Director TMH Professor and Surgeon |
| Affiliation |
TATA MEMORIAL HOSPITAL |
| Address |
TATA MEMORIAL HOSPITAL
Department of Surgical Oncology 3rd floor homibhabha block room number 325 Dr E Borges Marg Parel Mumbai INDIA Mumbai MAHARASHTRA 400012
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9820224761 |
| Fax |
|
| Email |
shailushrikhande@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shailesh Shrikhande |
| Designation |
Deputy Director TMH Professor and Surgeon |
| Affiliation |
TATA MEMORIAL HOSPITAL |
| Address |
TATA MEMORIAL HOSPITAL
Department of Surgical Oncology 3rd floor homibhabha block room number 325 Dr E Borges Marg Parel Mumbai INDIA Mumbai MAHARASHTRA 400012
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9820224761 |
| Fax |
|
| Email |
shailushrikhande@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shailesh Shrikhande |
| Designation |
Deputy Director TMH Professor and Surgeon |
| Affiliation |
TATA MEMORIAL HOSPITAL |
| Address |
TATA MEMORIAL HOSPITAL
Department of Surgical Oncology 3rd floor homibhabha block room number 325 Dr E Borges Marg Parel Mumbai INDIA Mumbai MAHARASHTRA 400012
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9820224761 |
| Fax |
|
| Email |
shailushrikhande@hotmail.com |
|
|
Source of Monetary or Material Support
|
| No funding required for this study as retrospective observational study. Infrastructure support -Tata Memorial Hospital Dr Ernest Borges Marg Parel Mumbai 400012 |
|
|
Primary Sponsor
|
| Name |
UNIVERSITY HOSPITAL HALLE |
| Address |
Ernst Grube Strabe 40 06120 Halle (Saale) Germany |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
China
Germany
India
Ireland
Italy
Turkey
United Kingdom |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shailesh Shrikhande |
Tata Memorial Hospital |
Department of Surgical oncology 3rd floor Homibhaba block room no 325 Tata Memorial Hospital Dr E Borges Marg Parel Mumbai INDIA
Mumbai
MAHARASHTRA |
9820224761
shailushrikhande@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Tata Memorial Hospital Institutional Ethics Committee 1 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K869||Disease of pancreas, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Consecutive patients undergoing elective multivisceral oncological resections involving the pancreas between January 1st 2010 and December 31st 2022 will be included |
|
| ExclusionCriteria |
| Details |
patients who underwent isolated pancreatic resection for pancreatic metastasis or revision pancreatectomies will be excluded from this analysis
Patients who were not undergoing oncological resections e g traumatic lesions or those who did not undergo surgery as curative intent will be also excluded from the study
Patients with incomplete data incomplete/not mentioned on EMR will be excluded from this study |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Determine factors associated with morbidity, mortality, overall survival and diseasefree survival.
|
For overall and diseases free survival timepoint is 5 years and for mobidity and motality timepoint is 90 days after the surgery. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Disease-Free Survival (DFS) / Recurrence-Free Survival – Based on recurrence data.
|
5 years after the surgery |
Morbidity and Mortality Rates Including 90 day mortality and postoperative complications classified by Clavien-Dindo.
|
90 days after the surgery |
| Postoperative Specific Complications |
90 days after the surgery |
|
|
Target Sample Size
|
Total Sample Size="1000"
Sample Size from India="197"
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)
|
30/09/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/07/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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
|
This retrospective multicenter study involves centers on a global scale performing multivisceral oncological resections involving the pancreas A retrospective analysis conducted across multiple international centers will serve to achieve the aforementioned objectives In accordance with the local standards of participating centers individual patient consent processes may be pursued for study recruitment Some centers may have ethical or legal requirements that necessitate obtaining patient consent This approach allows for flexibility to accommodate centers where patient consent is mandatory ensuring their participation in the study However it should be noted that in centers where patient consent is not required by local standards and where there are no interventions or deviations from established treatment protocols the default approach will be to share only anonymized data This flexibility acknowledges the diversity of regulations and ethical considerations across different nations and institutions enabling the study to proceed while respecting local requirements |