| CTRI Number |
CTRI/2025/08/092932 [Registered on: 12/08/2025] Trial Registered Prospectively |
| Last Modified On: |
12/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Studying antibiotic use and risk of infections after Whipple surgery for pancreatic and related conditions |
|
Scientific Title of Study
|
ANTIBIOTIC DURATION AND INFECTIOUS COMPLICATIONS IN PATIENTS UNDERGOING PANCREATICODUODENECTOMY- A RANDOMISED STUDY |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
RAPOLU SRI CHANDANA DEEPTHI |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH, CHANDIGARH |
| Address |
DEPARTMENT OF GENERAL SURGERY,5TH LEVEL, B BLOCK, NEHRU HOSPITAL, POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH, CHANDIGARH-12
DEPARTMENT OF GENERAL SURGERY,5TH LEVEL, B BLOCK, NEHRU HOSPITAL, POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH, CHANDIGARH-12
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7470340499 |
| Fax |
|
| Email |
deepthichandana48@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
PROF LILESWAR KAMAN |
| Designation |
PROFESSOR |
| Affiliation |
POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH,CHANDIGARH |
| Address |
DEPARTMENT OF GENERAL SURGERY,5TH LEVEL, B BLOCK, NEHRU HOSPITAL, POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH, CHANDIGARH-12
DEPARTMENT OF GENERAL SURGERY,5TH LEVEL, B BLOCK, NEHRU HOSPITAL, POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH, CHANDIGARH-12
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7087009644 |
| Fax |
|
| Email |
kamanlil@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
RAPOLU SRI CHANDANA DEEPTHI |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
POST GRADUATE INSTITUTE OF ME,DICAL EDUCATION AND RESEARCHCHANDIGARH |
| Address |
DEPARTMENT OF GENERAL SURGERY,5TH LEVEL, B BLOCK, NEHRU HOSPITAL, POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH, CHANDIGARH-12
DEPARTMENT OF GENERAL SURGERY,5TH LEVEL, B BLOCK, NEHRU HOSPITAL, POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH, CHANDIGARH-12
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7470340499 |
| Fax |
|
| Email |
deepthichandana48@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of General Surgery, 5th level, B block,PGIMER Chandigarh,India 160012 |
|
|
Primary Sponsor
|
| Name |
POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH |
| Address |
PGIMER CHANDIGARH, INDIA 160012 |
| 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 |
| RAPOLU SRI CHANDANA DEEPTHI |
POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH |
DEPARTMENT OF GENERAL SURGERY,5TH LEVEL, B BLOCK, NEHRU HOSPITAL, POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH, CHANDIGARH-12
Chandigarh
CHANDIGARH |
7470340499
deepthichandana48@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K80-K87||Disorders of gallbladder, biliary tract and pancreas, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ANTIBIOTIC DURATION |
Patients undergoing pancreaticoduodenectomy, divided in two groups - Group A and B.Each patient will be assigned to one of two groups through the use of a set of sealed envelope method of generalised random numbers. Group A receives antibiotic empirically Injection Piperacillin+Tazobactam, can be changed to culture sensitive antibiotic later -for 4days (96hrs) and group B receives for 8days(192hrs). |
| Comparator Agent |
TO STUDY THE INFECTIOUS COMPLICATIONS |
Primary objective- To assess the effect of the antibiotic duration in two groups- group A 4days and group B 8days undergoing pancreaticoduodenectomy with infectious complications mainly surgical site infection (SSI) postoperatively
Other objectives- even to assess the reduction in incidence of post operative infectious complications other than SSI like intra abdominal abscess, post operative pancreatitis, cholangitis and non specific infectious complications such as pneumonia, urinary tract infection, sepsis and long term hospital stay |
|
|
Inclusion Criteria
|
| Age From |
18.00 Day(s) |
| Age To |
80.00 Day(s) |
| Gender |
Both |
| Details |
1.Patients willing to give consent to participate in the study
2.Either gender
3. AGE 18-80years
4.Patient undergoing elective- Whipple - pancreaticoduodenectomy for benign and malignant etiology
5. Injection Piperacillin +tazobactam 4.5g IV four times a day will be given empirically. Antibiotic will be replaced according to intraoperative bile culture and sensitivity
6.Renal dose adjustment of antibiotic done in patients with renal impairment |
|
| ExclusionCriteria |
| Details |
1.Patient not giving informed consent
2.Patients undergoing total pancreatectomy, distal pancreatectomy, enucleation
3.Postoperative complications other than infectious complications
4.If patients of group A develop prolonged septic complications requiring extended antibiotic course will either be excluded or be accounted in group B
5.Patient operated outside, lost to follow up, developing organ failure and requiring ICU admission |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| TO ASSESS CORRELATION BETWEEN THE REDUCTION IN INCIDENCE OF SURGICAL SITE INFECTIONS AND ANTIBIOTIC DURATION IN PATIENTS UNDERGOING PANCREATICODUODENECTOMY |
Outcomes will be assessed postoperatively at the baseline during hospital stay, 1 month and 3 months after surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Other infectious complications assessment like intra abdominal abscess, postoperative pancreatitis, cholangitis, urinary tract infection, pneumonia, sepsis and length of hospital stay |
TILL 3 MONTHS |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
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)
|
23/08/2025 |
| 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="0"
Months="10"
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 - NO
|
|
Brief Summary
|
Pancreaticoduodenectomy is a high-complexity surgery associated with significant postoperative infectious morbidity. Perioperative antibiotics are standard practice, however the optimal duration of administration remains unclear. This study will compare different durations of perioperative antibiotic therapy in patients undergoing pancreaticoduodenectomy to determine their impact on the incidence, type and severity of postoperative infectious complications. The findings aim to inform evidence based guidelines, improve patient outcomes and promote rational antibiotic use |