Multivisceral Oncological Resections Involving the Pancreas An International Multicenter Study MORIP AIMS
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 1,000
- Locations
- 1
- Primary Endpoint
- Determine factors associated with morbidity, mortality, overall survival and diseasefree survival.
Study Overview
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
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 18.00 Year(s) to 80.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Consecutive patients undergoing elective multivisceral oncological resections involving the pancreas between January 1st 2010 and December 31st 2022 will be included.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Determine factors associated with morbidity, mortality, overall survival and diseasefree survival.
Time Frame: For overall and diseases free survival timepoint is 5 years and for mobidity and motality timepoint is 90 days after the surgery.
Secondary Outcomes
- Disease-Free Survival (DFS) / Recurrence-Free Survival – Based on recurrence data.
- Morbidity and Mortality Rates Including 90 day mortality and postoperative complications classified by Clavien-Dindo.
- Postoperative Specific Complications(90 days after the surgery)
Investigators
Dr Shailesh Shrikhande
TATA MEMORIAL HOSPITAL
