| CTRI Number |
CTRI/2024/06/068749 [Registered on: 12/06/2024] Trial Registered Prospectively |
| Last Modified On: |
11/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Analysis of complications in patients undergoing surgery for cancer of the pancreas and duodenum in a referral cancer hospital.
|
|
Scientific Title of Study
|
Surgical outcomes in pancreatoduodenectomy- an observational prospective analysis in a tertiary referral cancer center. |
| 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 Mayank Tripathi |
| Designation |
Associate professor |
| Affiliation |
Mahamana Pandit Madan Mohan Malaviya Cancer Centre, Varanasi |
| Address |
Dept of Surgical Oncology, 1st floor, D & T block, Mahamana Pandit Madan Mohan Malaviya Cancer Centre, Sundar Bagiya, Near Nariya gate, BHU Campus, Varanasi.
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
918059420490 |
| Fax |
|
| Email |
drmayanktripathi1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mohd Irfan Ansari |
| Designation |
Senior resident |
| Affiliation |
Mahamana Pandit Madan Mohan Malaviya Cancer Centre, Varanasi |
| Address |
Dept of Surgical Oncology, 1st floor, D & T block, Mahamana Pandit Madan Mohan Malaviya Cancer Centre, Sundar Bagiya, Near Nariya gate, BHU Campus, Varanasi.
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
918754845970 |
| Fax |
|
| Email |
irfan908@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mayank Tripathi |
| Designation |
Associate professor |
| Affiliation |
Mahamana Pandit Madan Mohan Malaviya Cancer Centre, Varanasi |
| Address |
Dept of Surgical Oncology, 1st floor, D & T block, Mahamana Pandit Madan Mohan Malaviya Cancer Centre, Sundar Bagiya, Near Nariya gate, BHU Campus, Varanasi.
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
918059420490 |
| Fax |
|
| Email |
drmayanktripathi1@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dept of Surgical Oncology, 1st floor, D & T block, Mahamana Pandit Madan Mohan Malaviya Cancer Centre, Sundar Bagiya, Near Nariya gate, BHU Campus, Varanasi, Uttar Pradesh. |
|
|
Primary Sponsor
|
| Name |
Mahamana Pandit Madan Mohan Malaviya Cancer Centre |
| Address |
Mahamana Pandit Madan Mohan Malaviya Cancer Centre, Sundar Bagiya, Near Nariya Gate, BHU Campus, Varanasi, Uttar Pradesh - 221005 |
| 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 |
| Dr Mayank Tripathi |
Mahamana Pandit Madan Mohan Malaviya Cancer Centre |
Dept of Surgical Oncology, 1st floor, D & T block, Sundar Bagiya, Near Nariya gate, BHU campus, Varanasi, Uttar Pradesh, 221005.
Varanasi
UTTAR PRADESH |
8059420490
drmayanktripathi1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (IEC) MPMMCC and HBCH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C170||Malignant neoplasm of duodenum, (2) ICD-10 Condition: C248||Malignant neoplasm of overlappingsites of biliary tract, (3) ICD-10 Condition: C258||Malignant neoplasm of overlappingsites of pancreas, (4) ICD-10 Condition: C259||Malignant neoplasm of pancreas, unspecified, (5) ICD-10 Condition: D490||Neoplasm of unspecified behavior of digestive system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NOT APPLICABLE |
NOT APPLICABLE |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
All consecutive patients undergoing pancreatoduodenectomy during the study period, with:
1. Age 18 to 80 years
2. ECOG less than 3
3. Patient undergoing pancreatoduodenectomy surgery for cancer involving duodenum, duodenal ampulla, bile duct, and head of pancreas.
|
|
| ExclusionCriteria |
| Details |
1. Patients who do not undergo complete resection and pancreatobiliaryenteric reconstruction.
2. Patients who are found to be metastatic on exploration.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Rate and severity of postoperative complications esp. Clavein-Dindo (CD) classification, esp. CD ≥3 rates which includes POPF rates (postoperative pancreatic fistula), DGE rates (delayed gastric emptying), bile leak rates, postoperative hemorrhage rates, and re-exploration rates, SSI (surgical site infection) rates, pulmonary complications rate, cardiac complications rate, and renal complications rate. |
30 days post surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Postoperative histopathology stage and site of tumor, pathological diagnosis, Number of lymph nodes dissected, number of positive lymph nodes, lympho-vascular infiltration, perineural infiltration, perivascular infiltration, resection status (R0, R1, R2).
|
30 days post surgery |
Positive Intraop Bile culture and sensitivity.
|
30 days post surgery |
Presence and type of preoperative biliary drainage and interval between drainage and surgery.
|
30 days post surgery |
Post neoadjuvant exploration rates
|
30 days post surgery |
Length of hospital stay/ ICU stay
|
90 days post surgery |
30-day mortality
|
30 days post surgery |
90- day mortality
|
90 days post surgery |
| Re-admission rates |
90 days post surgery |
|
|
Target Sample Size
|
Total Sample Size="94"
Sample Size from India="94"
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)
|
24/06/2024 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [drmayanktripathi1@gmail.com].
- For how long will this data be available start date provided 19-12-2026 and end date provided 18-12-2031?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This study is an observational prospective study in which patients undergoing pancreatoduodenectomy surgery (for oncological indications) at a tertiary cancer referral centre in North India, will be followed up along their patient pathway (i.e. first visit à work-up à plan à admission and surgery à discharge and follow-up). The primary outcome measure will be the rate and severity of postoperative complications (refer to part 7). Various secondary outcome measures will be gathered including readmission rate, 30 days and 90 days mortality (refer to part 7). An insight into the various outcome variables can help us gain a perspective, and possibly add to the present evidence and practice. |