| CTRI Number |
CTRI/2023/07/055280 [Registered on: 17/07/2023] Trial Registered Prospectively |
| Last Modified On: |
25/04/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Study on effectiveness of Hydrocortisone in reducing complications of pancreatic surgery |
|
Scientific Title of Study
|
Efficacy of peri operative hydrocortisone treatment in reducing post operative complications after pancreatic resection - A Randomised Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anantha krishna V R |
| Designation |
Assistant Professor |
| Affiliation |
Government Medical College, Thiruvananthapuram. |
| Address |
Department of Surgical gastroenterology,
Super Speciality Block,
Government Medical College,
Thiruvananthapuram
Thiruvananthapuram
KERALA
695011
India |
| Phone |
9447376367 |
| Fax |
|
| Email |
akvrkrsna@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Anantha krishna V R |
| Designation |
Assistant Professor |
| Affiliation |
Government Medical College, Thiruvananthapuram. |
| Address |
Department of Surgical gastroenterology,
Super speciality Block,
Government medical college,
Thiruvananthapuram
Thiruvananthapuram
KERALA
695011
India |
| Phone |
9447376367 |
| Fax |
|
| Email |
akvrkrsna@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Anantha krishna V R |
| Designation |
Assistant Professor |
| Affiliation |
Government Medical College, Thiruvananthapuram. |
| Address |
Department of Surgical gastroenterology,
Super Speciality Block,
Government Medical College,
Thiruvananthapuram
Thiruvananthapuram
KERALA
695011
India |
| Phone |
9447376367 |
| Fax |
|
| Email |
akvrkrsna@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. ANANTHA KRISHNA V R,
ASSISTANT PROFESSOR,
DEPARTMENT OF SURGICAL GASTROENTEROLOGY,
GOVERNMENT MEDICAL COLLEGE,
THIRUVANANTHAPURAM,
KERALA - 695011 |
|
Primary Sponsor
Modification(s)
|
| Name |
Dr Anantha Krishna V R |
| Address |
Treasa Cottage,
Chayakkudy Road, Pettah,
Thiruvananthapuram - 695024
|
| Type of Sponsor |
Other [Self] |
|
|
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 ANANTHA KRSIHNA V R |
Government Thiruvananthapuram Medical College |
Department of Surgical Gastroenterology, Super Speciality Block, Government Medical College, Thiruvananthapuram - 695011
Thiruvananthapuram
KERALA |
9447376367
akvrkrsna@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| HUMAN ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K869||Disease of pancreas, unspecified, (2) ICD-10 Condition: C259||Malignant neoplasm of pancreas, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
0.9 % NORMAL SALINE (PLACEBO) |
The control / Comparator group receives 100 ml 0.9% Isotonic Normal saline every eight hours until the second postoperative day (total of 9 doses). |
| Intervention |
HYDROCORTISONE |
The intervention group receives Hydrocortisone 100 mg in 100 ml 0.9% NS every eight hours until the second postoperative day (total of 9 doses). |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients undergoing elective pancreatic resection for benign / malignant lesions ( Pancreaticoduodenecomty / Distal Pancreatectomy ± Splenectomy / Median Pancreatectomy )
2. Patients giving consent for trial |
|
| ExclusionCriteria |
| Details |
1.Patients < 18 years of age
2.Patients currently receiving systemic therapy with glucocorticoids for last 3 months
3.Patients with chronic pancreatitis
4.Patients with recent infection ( infection within 2 weeks) Cholangitis, Pneumonia, UTI
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Frequency of patients with postoperative complications occurring within 90 days after surgery. |
Within 90 days of surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Development of clinically significant Post operative pancreatic fistula |
within 90 days of surgery |
| Development of Post operative Pancreatic Hemorrhage |
within 90 days of surgery |
| Development of Delayed Gastric Emptying |
within 90 days of surgery |
| Length of hospital stay |
within 90 days of surgery |
| Ninety-day post operative mortality |
within 90 days of surgery |
|
|
Target Sample Size
|
Total Sample Size="128"
Sample Size from India="128"
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
|
Phase 2/ Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
01/08/2023 |
| 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="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
Modification(s)
|
Pancreatic resection carries a high morbidity of 30%–60% and a mortality of 5%. Several trials have been undertaken in the past decades to address this problem and reduce the incidence of pancreatic fistula as well as overall complication. Despite rigorous research, postoperative pancreatic fistula poses a significant challenge to surgeons given the fact that up to every third patient at high risk will develop a clinically significant pancreatic fistula after pancreatic surgery.
The greater morbidity seems to result from the systemic inflammatory response as pathophysiological reaction to tissue injury. Glucocorticoids are potent anti-inflammatory drugs that modulate expression of both inflammatory and anti inflammatory genes.There is limited but compelling evidence that peri-operative glucocorticosteroid can attenuate the inflammatory response, which in turn, can result in decreased post operative complications. Trials have shown the beneficial effect of corticosteroids in reducing morbidity and mortality of liver resection.There is paucity of data to show that glucocorticosteroids reduce the risk of major complications in high-risk pancreatic surgery patients. Only few foreign trials are done.
Hence this study is undertaken to study the efficacy of peri operative hydrocortisone treatment in reducing post operative complications after pancreatic resection by comparing with the placebo. |