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CTRI Number  CTRI/2024/05/067619 [Registered on: 20/05/2024] Trial Registered Prospectively
Last Modified On: 21/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Synbiotic]  
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Effect of Synbiotics After Pancreatoduodenectomy 
Scientific Title of Study   Impact of Perioperative Synbiotics on Infectious Complications After Pancreatoduodenectomy - A Randomised Controlled Trial 
Trial Acronym  SPICE-PD 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Selvakumar B 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences, Jodhpur 
Address  Department of Surgical Gastroenterology, Room 547, 5th Floor C block, OPD Complex, All India Institute of Medical Sciences, Basni Industrial Area phase 2

Jodhpur
RAJASTHAN
342005
India 
Phone  8004502603  
Fax    
Email  selvasriram87@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Katta Bhavana 
Designation  MCh Senior Resident - 1st year 
Affiliation  Department of Surgical Gastroenterology 
Address  All India Institute of Medical Sciences, Basni Industrial Area phase 2

Jodhpur
RAJASTHAN
342005
India 
Phone  8004502603  
Fax    
Email  bhavana7katta@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Selvakumar B 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences, Jodhpur 
Address  Department of Surgical Gastroenterology, Room 547, 5th Floor C Block, OPD Complex, All India Institute of Medical Sciences(AIIMS), Basni Industrial Area phase 2

Jodhpur
RAJASTHAN
342005
India 
Phone  8004502603  
Fax    
Email  selvasriram87@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences, Jodhpur 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences, Jodhpur 
Address  Basni Industrial Area phase 2, Jodhpur - 342005 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Selvakumar B  All India Institute of Medical Sciences, Jodhpur  Department of Surgical Gastroenterology, Room 547, 5th Floor C Block, OPD Complex, Basni Industrial Area Phase 2, Jodhpur - 342005
Jodhpur
RAJASTHAN 		 91-8004502603

selvasriram87@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee - All India Institute of Medical Sciences, Jodhpur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C250||Malignant neoplasm of head of pancreas, (2) ICD-10 Condition: C241||Malignant neoplasm of ampulla of Vater, (3) ICD-10 Condition: C240||Malignant neoplasm of extrahepaticbile duct, (4) ICD-10 Condition: C170||Malignant neoplasm of duodenum, (5) ICD-10 Condition: K861||Other chronic pancreatitis,  
 
Intervention / Comparator Agent
Modification(s)  
Type  Name  Details 
Comparator Agent  No additional drug would be given. Only routine medications needed for standard post-operative care (proton pump inhibitors, analgesics and antibiotics)  Patients would receive routine postoperative management given for patients after a pancreatoduodenectomy surgery as per current standards 
Intervention  Synbiotic capsule containing a fixed combination of 6 probiotics and one prebiotic Sl No Item Dosage Probiotic 1 Lactobacillus sps(acidophilus, rhamnosus, paracasei) 4 billion CFU 2 Bacillus sps (clausii, mesentericus, lactic acid bacillu) 2 billion CFU 3 Bifidobacterium lactis 60million CFU 4 Saccharomyces boulardii 30 million CFU 5 Streptococcus faecalis 60 million CFU 6 Clostridium butyricum 4 million CFU Prebiotic 1 Fructo-oligosaccharides 100 mg   Dose: 1 symbiotic capsule/day Route of administration: By mouth Frequency: Once a day Duration of therapy: 10 days (2 days before surgery and 8 days after surgery, starting from post-operative day 1)  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  The patients who undergo pancreatoduodenectomy for any indication and consent for the study 
 
ExclusionCriteria 
Details  1. The patients who undergo pancreatoduodenectomy for any indication but refuse consent
2. The patients who undergo pancreatoduodenectomy for any indication but received therapeutic antibiotics for 1 week preceding the date of surgery, for any active infection like pneumonia, cholangitis etc 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Any post-pancreatoduodenectomy infective complications like surgical site infection, pneumonia, intra-abdominal abscess/collection, urinary tract infection, central-line associated infection, bacteremia, fungemia etc  30 days 
 
Secondary Outcome  
Outcome  TimePoints 
To assess postoperative non-infectious morbidity

 		 30 days 
To assess length of ICU and hospital stay  Post-operative day when patient was shifted out of ICU and discharged from ward 
 
Target Sample Size   Total Sample Size="72"
Sample Size from India="72" 
Final Enrollment numbers achieved (Total)= "122"
Final Enrollment numbers achieved (India)="122" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   29/05/2024 
Date of Study Completion (India) 30/11/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Completed 
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  

Aim 

To study the role of perioperative synbiotics in decreasing infectious complications after pancreatoduodenectomy (PD)

Objectives:

Primary objective: 

To assess the 30-day post-PD infective complications.

Secondary objective: 

a)     30-day postoperative non-infectious morbidity

b)     Postoperative length of ICU and hospital stay 

Detailed methodology: 

Study setting

All the patients undergoing PD and meeting inclusion criteria during the study period will be recruited from Department of Surgical Gastroenterology, AIIMS, Jodhpur.

Duration of study

From 15th May 2024 to 30th November 2025

Sample size

Sommacal H M et al 2015 have reported postoperative infectious complications as 69% in conventional group as compared to 26% in intervention group. To detect a 50% decrease in postoperative infectious complications from the conventional group to the interventional group, we estimate a sample size of 36 patients per group with an alpha error of 5%, power of 80% and 10% contingency dropouts. Thus a total of 72 patients would be enrolled.

Study design

It is a single-center open-label randomized controlled study 

Inclusion Criteria:

a)     Patients who undergo PD for any indication 

b)    Aged 18-80 years 

Exclusion Criteria:

a)     Patients who refused consent

b)    Patients who received therapeutic antibiotics within 1 week before the operation

 

Written informed consent for participation will be obtained from each subject before enrolling them for the study. The study will be sent to Institutional Ethical Committee for approval prior to commencement of the study.

Randomization :

Patients will be stratified based on whether they are biliary-stented or non-stented. These will be randomly allocated to the Synbiotic or Conventional Care groups using the Sequentially Numbered Opaque Sealed Envelope (SNOSE) technique. The allocation will be blinded and random. There will be no blinding of study participants or study investigators (open-label)

Preoperative evaluation:

Patients planned for PD will undergo detailed history and clinical examination. Routine laboratory investigations including complete blood counts, liver and renal function tests, serum electrolytes, viral markers and coagulation profile will be done. Side viewing endoscopy with biopsy, contrast-enhanced computed tomography (CECT) or contrast-enhanced magnetic resonance imaging (MRI) will be done as clinical indicated. Tumor markers (CA 19-9 and CEA) will be performed in all patients suspicious of malignancy.  Baseline serum CRP and Procalcitonin will be done in one day prior to surgery. Patients witll undergo a preoperative anesthetic check-up to assess fitness for PD. All the details will be recorded in a pre-designed proforma. Patients allotted to Synbiotics group will receive one capsule of synbiotics with six probiotic bacteria and one prebiotic, 2 days prior to and 8 days after surgery, as per the following composition:

Sl No

Item

Dosage

 

Probiotic

 

1

Lactobacillus sps(acidophilus, rhamnosus, paracasei)

4 billion CFU

2

Bacillus sps (clausii, mesentericus, lactic acid bacillu)

2 billion CFU

3

Bifidobacterium lactis

60million CFU

4

Saccharomyces boulardii

30 million CFU

5

Streptococcus faecalis

60 million CFU

6

Clostridium butyricum

        4 million CFU

 

Prebiotic

 

1

Fructo-oligosaccharides

                          100 mg

 

Surgical procedure:

PD will be performed as per standardized protocol in the Department of Surgical Gastroenterology, AIIMS Jodhpur. 

Intraoperative Bile culture :

Before transection of bile duct, bile will be aspirated and sent for culture.  If the patient has CBD stent in situ, upper tip of the stent will be sent for culture.

Post-operative follow-up:

Follow up will be done as per  standardized perioperative protocol. Serum CRP and Procalcitonin will be measured on post-operative day (POD)-1, POD-3 and POD-5. Amylase levels in serum and drain fluid and drain cultures will be sent on POD-3. Postoperative abdominal CECT will be performed when clinically indicated.  

After discharge, patients will be followed up till 30 post-operative days and their complications, both infectious and non-infectious, would be recorded. 

Statistical analysis

Quantitative data will be expressed as median ± interquartile range, and qualitative data as numbers (percentages). Chi-square and Fisher’s exact test will be used to compare categorical variables. Continuous data will be analyzed with the Mann-Whitney U test. The statistical calculations will be done using the Statistical Package for Social Sciences software (SPSS) version 23.0 (IBM Technologies, Chicago, IL).

Ethical consideration

All study subjects will be included after receiving informed written consent. The patient is not being exposed to extra investigations for inclusion in this study. However, all patients enrolled in the study will receive standard care management and participation in the study will not lead to a change in their usual diagnostic workup, follow-up, or management. All personal data collected during the study will be kept strictly confidential. 

The study protocol has been reviewed and approved by the Institute Ethics Committee.

 
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