| CTRI Number |
CTRI/2020/09/028027 [Registered on: 24/09/2020] Trial Registered Prospectively |
| Last Modified On: |
18/12/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Role of indomethacin suppository as a possible means to reduce complications related to Pancreatoduodenectomy. |
|
Scientific Title of Study
|
Efficacy of Rectal Indomethacin in prevention of post-operative pancreatitis after pancreaticoduodenectomy – a randomized controlled trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anubhav |
| Designation |
MBBS MS (General Surgery) Senior Resident (MCh HPB Surgery) |
| Affiliation |
Institute of Liver and Biliary Sciences |
| Address |
Senior Resident
Department of HPB & Liver Transplant Surgery
ILBS Hospital
Vasant Kunj
South West
DELHI
110070
India |
| Phone |
8860188337 |
| Fax |
|
| Email |
anubhav.pawar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Viniyendra Pamecha |
| Designation |
MBBS, MS, FEBS |
| Affiliation |
Institute of Liver and Biliary Sciences |
| Address |
Professor and Head
Department of HPB and Liver Transplant Surgery
ILBS
Vasant Kunj
South West
DELHI
110070
India |
| Phone |
9540946803 |
| Fax |
|
| Email |
viniyendra@yahoo.co.uk |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anubhav |
| Designation |
MBBS MS (General Surgery) Senior Resident (MCh HPB Surgery) |
| Affiliation |
Institute of Liver and Biliary Sciences |
| Address |
Senior Resident
Department of HPB and Liver Transplant Surgery
ILBS Hospital
Vasant Kunj
South West
DELHI
110070
India |
| Phone |
8860188337 |
| Fax |
|
| Email |
anubhav.pawar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. Anubhav, Senior Resident, Department of HPB and Liver Transplant Surgery, ILBS Hospital, Vasant Kunj, New Delhi |
|
|
Primary Sponsor
|
| Name |
Institute of Liver and Biliary Sciences |
| Address |
Vasant Kunj
New Delhi 110070 |
| 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 |
| Anubhav |
Institute of Liver and Biliary Sciences |
Department of HPB abd Liver Transplant Surgery, ILBS, Vasant Kunj
South West
DELHI |
8860188337
anubhav.pawar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC/2020/81/MA13 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C250||Malignant neoplasm of head of pancreas, (2) ICD-10 Condition: C240||Malignant neoplasm of extrahepaticbile duct, (3) ICD-10 Condition: C241||Malignant neoplasm of ampulla of Vater, (4) ICD-10 Condition: K838||Other specified diseases of biliary tract, (5) ICD-10 Condition: K862||Cyst of pancreas, (6) ICD-10 Condition: K860||Alcohol-induced chronic pancreatitis, (7) ICD-10 Condition: K861||Other chronic pancreatitis, (8) ICD-10 Condition: K831||Obstruction of bile duct, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
100mg of Indomethacin Suppository |
Single Dose 100mg Indomethacin Suppository administered Per-rectally at the time of Induction of Anesthesia prior to Pancreatoduodenectomy. |
| Comparator Agent |
Not applicable |
No placebo is required since the drug will be administered during anesthesia. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
All consenting adults planned to undergo pancreatoduodenectomy |
|
| ExclusionCriteria |
| Details |
1. Patients refusing to consent
2. History of asthma
3. History of allergic reactions to NSAIDs
4. History of renal dysfunction or CKD
5. E/o Internal hemorrhoids on examination
6. Patients on Anti-platelet drugs |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of Post-operative Pancreatitis |
Within 30 days of surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Post-operative pancreatic fistula rate |
within 30 days of surgery |
| Post-pancreaticoduodenectomy hemorrhage rate |
within 30 days of surgery |
| Delayed Gastric emptying rate |
within 30 days of surgery |
| Intra-abdominal collections/abscess rates |
within 30 days of surgery |
| Duration of ICU stay |
within 30 days of surgery |
| Length of Hospital Stay |
within 30 days of surgery |
| Risk factors for post-operative pancreatitis |
within 30 days of surgery |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
30/09/2020 |
| 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
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Pancreatico-duodenectomy is one of the commonly performed procedure for periampullary/distal cholangio/head of pancreas carcinoma. Post operative pancreatitis is an emerging concept, recently being studied as one of the most important contributing factor of Post-operative pancreatic fistula, which is one of the major complication of pancreatoduodenectomy. Rectal indomethacin, a type of non-steroidal anti-inflammatory drug, when given in a single dose has been shown to prevent pancreatitis in patients undergoing ERCP. In this study, we will be administering rectal indomethacin at the time of induction of anesthesia to the experimental arm of the study and compare the results in terms of incidence of post-operative pancreatitis in the two groups. |