| CTRI Number |
CTRI/2026/04/109015 [Registered on: 21/04/2026] Trial Registered Prospectively |
| Last Modified On: |
14/04/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Open Pancreaticoduodenectomy- Analysis of the learning curve |
|
Scientific Title of Study
|
Open Pancreaticoduodenectomy - Analysis Of Learning Curve |
| 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 Raghavendra D |
| Designation |
Assistant Professor |
| Affiliation |
Kastruba Medical College, Manipal, |
| Address |
Department of Gastrointestinal Surgery
4th floor, Smt Sharada Madhav Pai OPD
Kasturba medical college
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8725826655 |
| Fax |
|
| Email |
Kmc.raghavendra@manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Raghavendra D |
| Designation |
Assistant Professor |
| Affiliation |
Kastruba Medical College, Manipal, |
| Address |
Department of Gastrointestinal Surgery
4th floor, Smt Sharada Madhav Pai OPD
Kasturba medical college
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8725826655 |
| Fax |
|
| Email |
Kmc.raghavendra@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Raghavendra D |
| Designation |
Assistant Professor |
| Affiliation |
Kastruba Medical College, Manipal, |
| Address |
Department of Gastrointestinal Surgery
4th floor, Smt Sharada Madhav Pai OPD
Kasturba medical college
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8725826655 |
| Fax |
|
| Email |
Kmc.raghavendra@manipal.edu |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
No one |
| Address |
No one |
| Type of Sponsor |
Other [nil] |
|
|
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 Raghavendra |
DIVISION OF SURGICAL GASTROENTEROLOGY, KASTURBA HOSPITAL MANIPAL |
GEC OPD, 4TH floor, KASTURBA HOSPITAL MANIPAL
Udupi - Hebri Rd, Madhav Nagar, Manipal, Karnataka 576104
Udupi
KARNATAKA |
8725826655
kmc.raghavendra@maniapl.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional ethic comitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K87||Disorders of gallbladder, biliarytract and pancreas in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
All open pancreaticoduodenectomies from January 2019 to June 2025 |
|
| ExclusionCriteria |
| Details |
Cases deferred in view of unresectability
Cases with distant metastasis |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To analyze the learning curve of open PD |
4 weeks to 6 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Need for intra op blood transfusion of more than 2 units
2.Need for post operative ventilation
3.Length of prolonged icu stay
4.duration of hospital stay
5.post op complication
6.POPF
7.PPH
8.Mortality |
3. more than 2 days
4. admission to discharge
5. 4 weeks to 6 years
6. 4 weeks to 6 yeras
7. 4 weeks to 6 years
8. post op tp 6 years
5. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
25/04/2026 |
| 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="6"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Completed |
| 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
|
The following is a retrospective observational study done in order to analyse the learning curve associated with open pancreaticoduodenectomies and the associated post operative complications with the study |