Pancreas DiseaseNCT04514198
Postoperative Pancreatitis and Its Correlation With Clinically Relevant Pancreatic Fistula in Pancreaticoduodenectomy
An observational study of Pancreas Disease, run by Asian Institute of Gastroenterology, India at 1 site in India.
Trial summary
AIM To determine association between postoperative pancreatitis and pancreatic fistula OBJECTIVES 1. To determine incidence of Clinically relevant pancreatic fistula (grade B/C) after pancreaticoduodenectomy 2. To determine role of serum amylase levels on day 1 to predict clinically relevant pancreatic fistula 3. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Pancreas Disease
- How many people
- 140 participants
- Where
- 1 siteIndia
- Study dates
- 1 Mar 2020to 1 Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Sample size : Required 35 subjects
Who may be able to join
- All patients (>18 yrs) undergoing elective Whipple's PD in Asian institute of gastroenterology, Hyderabad, Telangana.
Who cannot join
- On table inoperable patients
- Patients in cholangitis or bilirubin > 15 mg/dl
- Patients not giving consent for participation
- Patients with acute inflammatory states (cholangitis, sepsis, trauma, acute on chronic pancreatitis)
Trial locations and contacts
1 site in 1 country.
India1 site
Asian Institute of Gastroenterology/AIG Hospitals
Hyderabad, Telangana, 500082
About this study
Official title: Postoperative Pancreatitis and Its Correlation With Clinically Relevant Pancreatic Fistula in Pancreaticoduodenectomy- A Prospective Observational Study
AIM
To determine association between postoperative pancreatitis and pancreatic fistula
Read more
OBJECTIVES
- To determine incidence of Clinically relevant pancreatic fistula (grade B/C) after pancreaticoduodenectomy
- To determine role of serum amylase levels on day 1 to predict clinically relevant pancreatic fistula
- To determine risk factors for postoperative pancreatitis and postoperative pancreatic fistula
Primaryendpoint:
Incidence of post operative pancreatitis and post operative pancreatic fistula.
Secondaryendpoints:
- to identify the possible predictors of post operative pancreatitis.
- to investigate the association between post operative pancreatitis and post operative pancreatic fistula.
MATERIAL AND METHODS
Study centre:
Inpatient admissions in Department of gastroenterology, Asian institute of gastroenterology, Hyderabad
Study population:
Patients who are supposed to undergo pancreaticoduodenectomy Study design: Prospective observational study
Study period:
Study will be conducted till desired sample size achieved or March 2020 to march 2022
Read the detailed description
STUDY PROCEDURE:
Demographic, pathological and intraoperative data will be recorded in a prospectively maintained database populated from a combination of electronic patient records, preoperative imaging and anaesthetic charts. Preoperative clinical data included age, gender, body mass index (BMI), and the results of serum biochemical investigations including serum bilirubin, urea and amylase. The serum amylase measured throughout the study period is total amylase. Preoperative computed tomography images will beanalyzed to calculate pancreatic duct diameter at the line of transection of the pancreas anterior to the portal vein. Intraoperative data included reconstruction technique, texture of the pancreatic remnant and estimated blood loss. Blood loss data will be compiled from a combination of anaesthetic charts and perioperative blood transfusion data. Specimens will be dichotomized according to whether their pathology was associated with hard pancreatic parenchyma [pancreatic ductal adenocarcinoma (PDAC) and chronic pancreatitis] or with soft or normal pancreatic parenchyma (ampullary carcinoma, duodenal carcinoma, cholangiocarcinoma, neuroendocrine tumours and other lesions). Outcome data included length of stay in a critical care environment [defined as either an intensive care unit (ICU) or a surgical high-dependency unit (SHDU)] and length of postoperative hospital stay. All postoperative complications will be prospectively recorded and graded according to the International Study Group on Pancreatic Fistula (ISGPF) and International Study Group of Pancreatic Surgery (ISGPS) classifications and the Clavien-Dindo classification. Complications of ISGPS Grades B and C and Clavien-Dindo Grades III-V are considered clinically significant. Mortality will be recorded at 30-day and 90-day time-points.
Serum amylase will be systematically measured on POD1 and POD3 according to our institutional policy. No additional radiological or laboratory studies are required for the diagnosis of postoperative pancreatitis. No specific protocols for the treatment of POP will be followed during the study period because none are available. Due to the absence of a widely accepted definition, POP is defined according to Connor's definition1 as an elevation in serum pancreatic amylase above the upper limit of normal on postoperative day (POD) 0 or 1. At our institution, the upper limit of normal for serum pancreatic amylase is 100 U/L.
- Conditions
- Pancreas Disease
- Medical subject headings
- Pancreatic Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
To estimate incidence of Post operative Pancreatitis and post operative pancreatic fistula among patients undergoing pancreaticoduodenectomies.
After pancreaticoduodenectomy surgery, pancreatitis occurs it is a local inflammatory process occurring in the area of the pancreatic anastomosis after pancreas resection could induce increased systemic amylase concentration, Amylase normal range is 28--100, if it exceeds the upper normal limits it leads to post operative pancreatitis, pancreatic fistula is defined as persistent drainage of amylase rich fluid (3x > than upper limit of normal serum amylase) for greater than 3 days.
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2020
- Study start1 Mar 2020
- Primary completion1 Jan 2022
- Study completion1 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pancreas DiseaseStudies of the same condition, open and under way.
- More trials run by Asian Institute of Gastroenterology, IndiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asian Institute of Gastroenterology, India
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohan Ramchandani, Asian Institute of Gastroenterology, India
- Investigators
- Dr Pradeep Rebala, MBBS MS MCH, Study chair, Asian Institute of Gastroenterology, IndiaDr Shasheendra yanagandula, MBBS MS, Principal investigator, Asian Institute of Gastroenterology, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04514198
- Sponsor's protocol ID
- POP001
- Status last verified
- Jan 2024
- First submitted
- 12 Aug 2020
- Last updated
- 3 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Shasheendra Y, Ahmed Z, Shetty MG, Hazarathaiah N, Rebala P, Rao GV. Association of Postoperative Hyperamylasemia With Clinically Relevant Postoperative Pancreatic Fistula in Pancreatoduodenectomy. Cureus. 2024 Jan 30;16(1):e53257. doi: 10.7759/cureus.53257. eCollection 2024 Jan.
PubMed 38435944
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Pancreatitis and Its Correlation With Clinically Relevant Pancreatic Fistula in Pancreaticoduodenectomy- A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT04514198
- Acronym / sponsor ID
- POP001
- Conditions
- Pancreas Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Asian Institute of Gastroenterology, IndiaUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 1 Mar 2022 (actual)
- First posted
- 14 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
AIM
To determine association between postoperative pancreatitis and pancreatic fistula
OBJECTIVES
- To determine incidence of Clinically relevant pancreatic fistula (grade B/C) after pancreaticoduodenectomy
- To determine role of serum amylase levels on day 1 to predict clinically relevant pancreatic fistula
- To determine risk factors for postoperative pancreatitis and postoperative pancreatic fistula
Primaryendpoint:
Incidence of post operative pancreatitis and post operative pancreatic fistula.
Secondaryendpoints:
- to identify the possible predictors of post operative pancreatitis.
- to investigate the association between post operative pancreatitis and post operative pancreatic fistula.
MATERIAL AND METHODS
Study centre:
Inpatient admissions in Department of gastroenterology, Asian institute of gastroenterology, Hyderabad
Study population:
Patients who are supposed to undergo pancreaticoduodenectomy Study design: Prospective observational study
Study period:
Study will be conducted till desired sample size achieved or March 2020 to march 2022
Detailed description
STUDY PROCEDURE:
Demographic, pathological and intraoperative data will be recorded in a prospectively maintained database populated from a combination of electronic patient records, preoperative imaging and anaesthetic charts. Preoperative clinical data included age, gender, body mass index (BMI), and the results of serum biochemical investigations including serum bilirubin, urea and amylase. The serum amylase measured throughout the study period is total amylase. Preoperative computed tomography images will beanalyzed to calculate pancreatic duct diameter at the line of transection of the pancreas anterior to the portal vein. Intraoperative data included reconstruction technique, texture of the pancreatic remnant and estimated blood loss. Blood loss data will be compiled from a combination of anaesthetic charts and perioperative blood transfusion data. Specimens will be dichotomized according to whether their pathology was associated with hard pancreatic parenchyma [pancreatic ductal adenocarcinoma (PDAC) and chronic pancreatitis] or with soft or normal pancreatic parenchyma (ampullary carcinoma, duodenal carcinoma, cholangiocarcinoma, neuroendocrine tumours and other lesions). Outcome data included length of stay in a critical care environment [defined as either an intensive care unit (ICU) or a surgical high-dependency unit (SHDU)] and length of postoperative hospital stay. All postoperative complications will be prospectively recorded and graded according to the International Study Group on Pancreatic Fistula (ISGPF) and International Study Group of Pancreatic Surgery (ISGPS) classifications and the Clavien-Dindo classification. Complications of ISGPS Grades B and C and Clavien-Dindo Grades III-V are considered clinically significant. Mortality will be recorded at 30-day and 90-day time-points.
Serum amylase will be systematically measured on POD1 and POD3 according to our institutional policy. No additional radiological or laboratory studies are required for the diagnosis of postoperative pancreatitis. No specific protocols for the treatment of POP will be followed during the study period because none are available. Due to the absence of a widely accepted definition, POP is defined according to Connor's definition1 as an elevation in serum pancreatic amylase above the upper limit of normal on postoperative day (POD) 0 or 1. At our institution, the upper limit of normal for serum pancreatic amylase is 100 U/L.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Sample size : Required 35 subjects
Key inclusion criteria (1 listed)
- All patients (>18 yrs) undergoing elective Whipple's PD in Asian institute of gastroenterology, Hyderabad, Telangana.
Key exclusion criteria (4 listed)
- On table inoperable patients
- Patients in cholangitis or bilirubin > 15 mg/dl
- Patients not giving consent for participation
- Patients with acute inflammatory states (cholangitis, sepsis, trauma, acute on chronic pancreatitis)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To estimate incidence of Post operative Pancreatitis and post operative pancreatic fistula among patients undergoing pancreaticoduodenectomies.
Time frame: 10 days
After pancreaticoduodenectomy surgery, pancreatitis occurs it is a local inflammatory process occurring in the area of the pancreatic anastomosis after pancreas resection could induce increased systemic amylase concentration, Amylase normal range is 28--100, if it exceeds the upper normal limits it leads to post operative pancreatitis, pancreatic fistula is defined as persistent drainage of amylase rich fluid (3x > than upper limit of normal serum amylase) for greater than 3 days.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2024.
- Derived from this study: PubMed 38435944Shasheendra Y, Ahmed Z, Shetty MG, Hazarathaiah N, Rebala P, Rao GV. Association of Postoperative Hyperamylasemia With Clinically Relevant Postoperative Pancreatic Fistula in Pancreatoduodenectomy. Cureus. 2024 Jan 30;16(1):e53257. doi: 10.7759/cureus.53257. eCollection 2024 Jan.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr Pradeep Rebala, MBBS MS MCH study chair
Asian Institute of Gastroenterology, India
Dr Shasheendra yanagandula, MBBS MS principal investigator
Asian Institute of Gastroenterology, India
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreas Disease, run by Asian Institute of Gastroenterology, India at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To estimate incidence of Post operative Pancreatitis and post operative pancreatic fistula among patients undergoing pancreaticoduodenectomies. (time frame: 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04514198, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2024.