Pancreatitis, ChronicNCT02048267
Surgical Outcome and Differences on Histopathology in Patients With Alcoholic & Non Alcoholic Chronic Pancreatitis
An observational study of Pancreatitis, Chronic, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
Trial summary
Numerous treatment modalities have been proposed to treat pain in alcoholic and non-alcoholic chronic pancreatitis such as analgesic medication, inhibition of gastric acid production, enzyme substitution, somatostatin analogues, nerve blockade,reduction of oxidative stress and endoscopic pancreatic duct stenting, but… Read more about this study
- Who is it for?
- Ages 15 to 65 years
- Conditions the study is for
- Pancreatitis, Chronic
- What is being tested?
- Frey's procedure/Pylorus preserving pancreatoduodenectomy
- Type of treatment
- Surgery or procedure
- How many people
- 24 participants
- Where
- 1 siteIndia
- Study dates
- Jan 2012to Jun 2014
- 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 15 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients of chronic pancreatitis with unremitting pain requiring surgery at primary care clinic
Who may be able to join
- Diagnosis of chronic pancreatitis confirmed by at least 2 of the following:
- Typical Chronic epigastric abdominal pain
- Elevation of serum Amylase>3 times upper limit normal or
- Fecal elastase less than 200ug/g stool.
- Confirmatory findings on cross-sectional imaging:
- Changes in size, shape and contour of pancreas
Show all 11Show fewer
- Dilatation of main pancreatic duct
- Calcification
- Pseudocyst
- Pancreatic duct stricture
- Patients who fulfill the criteria for surgical intervention
Who cannot join
- Not agreeing for surgical management
- On going acute pancreatitis
- Postop alcohol intake
- Pregnancy.
- Chronic pancreatitis with Malignancy
Trial locations and contacts
1 site in 1 country.
India1 site
Postgraduate Institute of Medical Education and Research
Chandigarh, Chandigarh, 160012
About this study
Official title: A Prospective Study of Surgical Outcome and Differences on Histopathology in Patients With Alcoholic & Non Alcoholic Chronic Pancreatitis
Numerous treatment modalities have been proposed to treat pain in alcoholic and non-alcoholic chronic pancreatitis such as analgesic medication, inhibition of gastric acid production, enzyme substitution, somatostatin analogues, nerve blockade,reduction of oxidative stress and endoscopic pancreatic duct stenting, but none of these concepts have shown long lasting benefits as surgery in clinical studies.Comparison of surgical outcome in non-alcoholic chronic pancreatitis and alcoholic chronic pancreatitis has limited data and differences on the basis of outcome in between alcoholic and non-alcoholic chronic pancreatitis are not available in literature.
Although it is well known that pain is the main symptom of chronic pancreatitis, it has until now been assessed in very common and varying categories. Pain, however, is only one aspect of the large variety of sensitive facets of daily life. In addition to an improvement in pain symptoms and the preservation of pancreatic exocrine and endocrine function and other parameters, occupational rehabilitation of these mostly young patients and quality of life also should be considered in the evaluation of surgical outcome in alcoholic and non-alcoholic chronic pancreatitis.
In this prospective study, we intend to find out if there are any differences in the surgical outcome on the above mentioned parameters in alcoholic and non-alcoholic chronic pancreatitis.We also plan to see if there are differences in the histopathology in these two disease settings.
- Conditions
- Pancreatitis, Chronic
- Being tested
- Frey's procedure/Pylorus preserving pancreatoduodenectomy
- Keywords
- Alcoholic, Non alcoholic, Idiopathic, Tropical, Exocrine dysfunction, Endocrine dysfunction, Pain control, Frey's procedure, Duodenum preserving pancreatic head resection
- Medical subject headings
- Pancreatitis, Chronic, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Frey's procedure/Pylorus preserving pancreatoduodenectomyProcedure or surgery
Duodenum preserving head resection
| Study group | Role | What they receive |
|---|---|---|
| Alcoholic | Not described Receives: Procedure: Frey's procedure/Pylorus preserving pancreatoduodenectomy | |
| Non alcoholic | Not described Receives: Procedure: Frey's procedure/Pylorus preserving pancreatoduodenectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life
Measured: Within first 6 months from the time of surgery
Differences in extent of parenchymal fibrosis, inflammation and ductal obstruction of alcoholic and non alcoholic chronic pancreatitis
Measured: Two weeks after surgery
Secondary outcomes (3)
Pain relief
Measured: Within first 6 months after surgery
HbA1C,Fasting insulin and C-peptide levels
Measured: Within first 6 months after surgery
Fecal elastase levels
Measured: Within first 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2014 (estimated)
- Study startJan 2012
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatitis, ChronicStudies of the same condition, open and under way.
- 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
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rajesh Gupta, Post Graduate Institute of Medical Education and Research, Chandigarh
- Investigators
- Rajesh Gupta, M.Ch., Principal investigator, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02048267
- Sponsor's protocol ID
- NK/338/MS/9609-1
- Status last verified
- Nov 2014
- First submitted
- 18 Jan 2014
- Last updated
- 11 Nov 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study of Surgical Outcome and Differences on Histopathology in Patients With Alcoholic & Non Alcoholic Chronic Pancreatitis
- ClinicalTrials.gov ID
- NCT02048267
- Acronym / sponsor ID
- NK/338/MS/9609-1
- Conditions
- Pancreatitis, Chronic
- Keywords
- Alcoholic, Non alcoholic, Idiopathic, Tropical, Exocrine dysfunction, Endocrine dysfunction, Pain control, Frey's procedure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, ChandigarhUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 29 Jan 2014 (estimated)
- 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.
Numerous treatment modalities have been proposed to treat pain in alcoholic and non-alcoholic chronic pancreatitis such as analgesic medication, inhibition of gastric acid production, enzyme substitution, somatostatin analogues, nerve blockade,reduction of oxidative stress and endoscopic pancreatic duct stenting, but none of these concepts have shown long lasting benefits as surgery in clinical studies.Comparison of surgical outcome in non-alcoholic chronic pancreatitis and alcoholic chronic pancreatitis has limited data and differences on the basis of outcome in between alcoholic and non-alcoholic chronic pancreatitis are not available in literature.
Although it is well known that pain is the main symptom of chronic pancreatitis, it has until now been assessed in very common and varying categories. Pain, however, is only one aspect of the large variety of sensitive facets of daily life. In addition to an improvement in pain symptoms and the preservation of pancreatic exocrine and endocrine function and other parameters, occupational rehabilitation of these mostly young patients and quality of life also should be considered in the evaluation of surgical outcome in alcoholic and non-alcoholic chronic pancreatitis.
In this prospective study, we intend to find out if there are any differences in the surgical outcome on the above mentioned parameters in alcoholic and non-alcoholic chronic pancreatitis.We also plan to see if there are differences in the histopathology in these two disease settings.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alcoholic | – | Procedure: Frey's procedure/Pylorus preserving pancreatoduodenectomy |
| Non alcoholic | – | Procedure: Frey's procedure/Pylorus preserving pancreatoduodenectomy |
Who may qualify
- Ages
- 15 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients of chronic pancreatitis with unremitting pain requiring surgery at primary care clinic
Key inclusion criteria (11 listed)
- Typical Chronic epigastric abdominal pain
- Elevation of serum Amylase>3 times upper limit normal or
- Fecal elastase less than 200ug/g stool.
- Confirmatory findings on cross-sectional imaging:
- Patients who fulfill the criteria for surgical intervention
Key exclusion criteria (5 listed)
- Not agreeing for surgical management
- On going acute pancreatitis
- Postop alcohol intake
- Pregnancy.
- Chronic pancreatitis with Malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Frey's procedure/Pylorus preserving pancreatoduodenectomyDuodenum preserving head resection | Procedure or surgery | Alcoholic, Non alcoholic |
Primary outcome
Quality of life
Time frame: Within first 6 months from the time of surgery
Differences in extent of parenchymal fibrosis, inflammation and ductal obstruction of alcoholic and non alcoholic chronic pancreatitis
Time frame: Two weeks after surgery
3 secondary outcomes
Pain relief
Time frame: Within first 6 months after surgery
HbA1C,Fasting insulin and C-peptide levels
Time frame: Within first 6 months after surgery
Fecal elastase levels
Time frame: Within first 6 months after surgery
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 11 Nov 2014.
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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.
Rajesh Gupta, M.Ch. principal investigator
Professor
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 Pancreatitis, Chronic, run by Post Graduate Institute of Medical Education and Research, Chandigarh 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 11 inclusion and 5 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 11 Nov 2014. 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?
Quality of life (time frame: Within first 6 months from the time of surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Nov 2014.