Chronic Calcific PancreatitisINFARCTNCT02735330
Intraoperative Coeliac Plexus Alcohol Neurolysis Along With Frey's Procedure for a Better Pain Relief
A study testing celiac plexus neurolysis using absolute alcohol and Frey's procedure in people with Chronic Calcific Pancreatitis, run by Madras Medical College.
Trial summary
To study the effect of Intra operative Coeliac plexus alcohol neurolysis combined with Frey's procedure for effective pain relief in patients with Chronic Calcific Pancreatitis in a single centre setting with a Randomized Controlled Trial. Read more about this study
- Who is it for?
- Ages 13 to 65 years
- Conditions the study is for
- Chronic Calcific Pancreatitis
- What is being tested?
- celiac plexus neurolysis using absolute alcohol and Frey's procedure
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 136 participants
- Where
- No sites listed yet
- Study dates
- Jan 2013to Sep 2019
- Phase
- Interventional
- 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 13 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Consecutive chronic calcific pancreatitis admitted in our institute since 2013 january with age group between 13 to 65 years with Visual analogue scale (VAS) pain score of more than 7 and those who have quit alcohol \& smoking for at least 6 months are included in our study.
Who cannot join
- Patients with mild to moderate pain score (VAS pain score 1-7), continuous substance abuse, severe comorbid illness are excluded from study.
About this study
Official title: Intra Operative Coeliac Plexus Neurolysis Combined With Frey's Procedure for Effective Pain Relief in Patients With Chronic Calcific Pancreatitis- A Prospective Randomized Double-blind Placebo Controlled Trial
To study the effect of Intra operative Coeliac plexus alcohol neurolysis combined with Frey's procedure for effective pain relief in patients with Chronic Calcific Pancreatitis in a single centre setting with a Randomized Controlled Trial.
Read the detailed description
165 consecutive CCP patients admitted in our surgical gastro enterology department since January 2013 were screened for eligibility. 29 patients were excluded (28 were not meeting the inclusion criteria and 1 patient intra operatively found to have disseminated malignancy). After exclusion 136 patients were included in our study. They were randomized in to 2 groups, one group was treated by Frey's procedure with NCPB (Group-I) and the other by Frey's procedure with saline as placebo (Group-II). Method of Study is a randomized, double- blind, placebo- controlled, parallel arm, superiority trial.
Randomization was done at the time of surgery using random number table created with computerized software by a statistician not involved in this study.
Blinding and masking was done by using pre numbered containers having filled with either absolute alcohol or saline according to the randomization chart which was then kept sealed by an office staff until the end of the study. Both subjects and response assessor were blinded.
Data collection:
The preoperative baseline details such as etiology, morphology, associated complications and VAS pain score, Izbicki pain score, weight loss, insulin requirement, LFT (liver function tests), serum amylase \& lipase, fasting sugar\& fecal elastase were collected on admission.
Additional procedures, presence of peripancreatic inflammatory changes (fibrosis) as evidenced by difficult Kocherisation and plasted capsule and intra-operative complications were noted during surgery.
Short term follow up details including pain relief measured by VAS score \&Izbicki pain score, analgesic consumption, weight gain, improvement in steatorrhoea (Fecal elastase>200 µg/g of stool \& subjective reduction in foul smelling oily diarrhea), diabetic status (fasting glucose, GTT, HgbA1c, insulin\& oral hypoglycemic agents requirement), mortality and morbidity were noted.
Follow up details were collected every 3 months as outpatient basis. Standard questionnaire format of SF 12 Version-2 was used for QOL assessment every 6 months in a face to face interview.
Statistical analysis was performed in SPSS version 20. Continuous variables were presented as mean, standard deviation and 95% confidence interval; categorical variables were presented as frequencies. The chi-square test and the Fisher exact test were used to analyze categorical variables. The unpaired Student t test was used to analyze continuous variables. P value <0.05 was considered statistically significant. Factors found significant on univariate logistic regression analysis were incorporated in to the multivariate logistic regression analysis for odds ratio with 95% confidence intervals to analyze the significant factors affecting the outcome of surgery.
- Conditions
- Chronic Calcific Pancreatitis
- Being tested
- celiac plexus neurolysis using absolute alcohol, Placebo celiac plexus injection using saline, Frey's procedure
- Keywords
- CCP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
celiac plexus neurolysis using absolute alcoholProcedure or surgery
Also called NCPB, Neurolytic celiac plexus block
celiac plexus blockade with 40 ml of diluted absolute alcohol(50%) 20 ml on either side of celiac axis in a 4 quadrant fashion
Placebo celiac plexus injection using salineProcedure or surgery
Also called Placebo
Placebo celiac plexus injection with 40 ml of saline 20 ml on either side of celiac axis in a 4 quadrant fashion for blinding
Frey's procedureProcedure or surgery
Also called Duodenum preserving pancreatic head coring procedure
Pancreatic head is partially resected (cored) along with longitudinal opening of duct along its entire length with limit of excavation of the head in the plane of the posterior wall of the Wirsung's duct and duct of Santorini is opened in the uncinate process. All the tissue above the plane, including the duct of Santorini is excised. The reconstruction is done with covering with a loop of jejunum in Roux-en-Y fashion which continues with the main pancreatic duct in the pancreatic body and tail.
| Study group | Role | What they receive |
|---|---|---|
| GROUP 1 | Active comparator | 68 Patients undergo Frey's procedure with celiac plexus neurolysis using absolute alcohol Receives: Procedure: celiac plexus neurolysis using absolute alcohol; Procedure: Frey's procedure |
| GROUP 2 | Placebo comparator | 68 Patients undergo Frey's procedure with Placebo celiac plexus injection using saline Receives: Procedure: Placebo celiac plexus injection using saline; Procedure: Frey's procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain relief measured by Visual Analogue Scale
Short term (2 years) and long term(5 years) score at follow up at out patient clinic or over phone.
Measured: up to 5 years
Secondary outcomes (7)
Number of patients with improvement in endocrine function as measured by Fasting glucose of < 130 and HbA1c level of <6.5%
and reduction in dosage of insulin (iu) \& oral hypoglycemic agents (milli gm) when compared to preoperative levels- at out patient clinic
Measured: up to 5 years
Number of patients with improvement or worsening in exocrine function as measured by the estimation of fecal elastase >200 µg/g of stool or <200 µg/g of stool respectively at out patient clinic.
Measured: up to 5 years
Analgesics intake
Dosage and frequency of intake of both NSAIDs and opioid analgesics intake are noted at out patient clinic or over phone.
Measured: up to 5 years
Weight gain in kg measured at out patient clinic
Measured: up to 5 years
Quality of life
Using SF 12 V2 (Tamil and english version-Optuminsight Life Sciences) in a face to face (written form) interview at out patient clinic
Measured: up to 5 years
Number of patients with worsening in endocrine function as measured by abnormal laboratory values like Fasting glucose >130 and HbA1c >6.5
and increased dosage of insulin (IU)\& oral hypoglycemic agents(milli gms) requirement when compared to preoperative levels at out patient clinic
Measured: up to 5 years
Number of patients with abnormal lab values like Fasting glucose of >126 mg/dl or blood glucose level of >200 after a standard glucose tolerance test (GTT) in equivocal cases.
Measured: up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2016 (estimated)
- Study startJan 2013
- Primary completionDec 2015
- Study completionSep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Calcific PancreatitisStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Madras Medical College
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Balakumaran Sathyamoorthy, Madras Medical College
- Investigators
- KANNAN DEVYGOUNDER, MS,MCh,FRCS, Study director, MADRAS MEDICAL COLLEGE,CHENNAI,TAMIL NADU,INDIABALAKUMARAN SATHYAMOORTHY, Principal investigator, MADRAS MEDICAL COLLEGE,CHENNAI,TAMIL NADU, INDIA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02735330
- Sponsor's protocol ID
- ID-NO 23052015
- Other IDs
- CTRI/2016/02/006593
- Acronym
- INFARCT
- Status last verified
- Apr 2016
- First submitted
- 16 Mar 2016
- Last updated
- 12 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: with out showing the name of the participants we can disclose the data of the all participants
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra Operative Coeliac Plexus Neurolysis Combined With Frey's Procedure for Effective Pain Relief in Patients With Chronic Calcific Pancreatitis- A Prospective Randomized Double-blind Placebo Controlled Trial
- ClinicalTrials.gov ID
- NCT02735330
- Acronym / sponsor ID
- INFARCT / ID-NO 23052015
- Conditions
- Chronic Calcific Pancreatitis
- Keywords
- CCP
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Madras Medical CollegeOther government
- Study start
- Jan 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Sep 2019 (estimated)
- First posted
- 12 Apr 2016 (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.
To study the effect of Intra operative Coeliac plexus alcohol neurolysis combined with Frey's procedure for effective pain relief in patients with Chronic Calcific Pancreatitis in a single centre setting with a Randomized Controlled Trial.
Detailed description
165 consecutive CCP patients admitted in our surgical gastro enterology department since January 2013 were screened for eligibility. 29 patients were excluded (28 were not meeting the inclusion criteria and 1 patient intra operatively found to have disseminated malignancy). After exclusion 136 patients were included in our study. They were randomized in to 2 groups, one group was treated by Frey's procedure with NCPB (Group-I) and the other by Frey's procedure with saline as placebo (Group-II). Method of Study is a randomized, double- blind, placebo- controlled, parallel arm, superiority trial.
Randomization was done at the time of surgery using random number table created with computerized software by a statistician not involved in this study.
Blinding and masking was done by using pre numbered containers having filled with either absolute alcohol or saline according to the randomization chart which was then kept sealed by an office staff until the end of the study. Both subjects and response assessor were blinded.
Data collection:
The preoperative baseline details such as etiology, morphology, associated complications and VAS pain score, Izbicki pain score, weight loss, insulin requirement, LFT (liver function tests), serum amylase \& lipase, fasting sugar\& fecal elastase were collected on admission.
Additional procedures, presence of peripancreatic inflammatory changes (fibrosis) as evidenced by difficult Kocherisation and plasted capsule and intra-operative complications were noted during surgery.
Short term follow up details including pain relief measured by VAS score \&Izbicki pain score, analgesic consumption, weight gain, improvement in steatorrhoea (Fecal elastase>200 µg/g of stool \& subjective reduction in foul smelling oily diarrhea), diabetic status (fasting glucose, GTT, HgbA1c, insulin\& oral hypoglycemic agents requirement), mortality and morbidity were noted.
Follow up details were collected every 3 months as outpatient basis. Standard questionnaire format of SF 12 Version-2 was used for QOL assessment every 6 months in a face to face interview.
Statistical analysis was performed in SPSS version 20. Continuous variables were presented as mean, standard deviation and 95% confidence interval; categorical variables were presented as frequencies. The chi-square test and the Fisher exact test were used to analyze categorical variables. The unpaired Student t test was used to analyze continuous variables. P value <0.05 was considered statistically significant. Factors found significant on univariate logistic regression analysis were incorporated in to the multivariate logistic regression analysis for odds ratio with 95% confidence intervals to analyze the significant factors affecting the outcome of surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GROUP 1 | Active comparator | Procedure: celiac plexus neurolysis using absolute alcohol, Procedure: Frey's procedure68 Patients undergo Frey's procedure with celiac plexus neurolysis using absolute alcohol |
| GROUP 2 | Placebo comparator | Procedure: Placebo celiac plexus injection using saline, Procedure: Frey's procedure68 Patients undergo Frey's procedure with Placebo celiac plexus injection using saline |
Who may qualify
- Ages
- 13 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Consecutive chronic calcific pancreatitis admitted in our institute since 2013 january with age group between 13 to 65 years with Visual analogue scale (VAS) pain score of more than 7 and those who have quit alcohol \& smoking for at least 6 months are included in our study.
Key exclusion criteria (1 listed)
- Patients with mild to moderate pain score (VAS pain score 1-7), continuous substance abuse, severe comorbid illness are excluded from study.
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 |
|---|---|---|
| celiac plexus neurolysis using absolute alcoholAlso: NCPB, Neurolytic celiac plexus blockceliac plexus blockade with 40 ml of diluted absolute alcohol(50%) 20 ml on either side of celiac axis in a 4 quadrant fashion | Procedure or surgery | GROUP 1 |
| Placebo celiac plexus injection using salineAlso: PlaceboPlacebo celiac plexus injection with 40 ml of saline 20 ml on either side of celiac axis in a 4 quadrant fashion for blinding | Procedure or surgery | GROUP 2 |
| Frey's procedureAlso: Duodenum preserving pancreatic head coring procedurePancreatic head is partially resected (cored) along with longitudinal opening of duct along its entire length with limit of excavation of the head in the plane of the posterior wall of the Wirsung's duct and duct of Santorini is opened in the uncinate process. All the tissue above the plane, including the duct of Santorini is excised. The reconstruction is done with covering with a loop of jejunum in Roux-en-Y fashion which continues with the main pancreatic duct in the pancreatic body and tail. | Procedure or surgery | GROUP 1, GROUP 2 |
Primary outcome
Pain relief measured by Visual Analogue Scale
Time frame: up to 5 years
Short term (2 years) and long term(5 years) score at follow up at out patient clinic or over phone.
7 secondary outcomes
Number of patients with improvement in endocrine function as measured by Fasting glucose of < 130 and HbA1c level of <6.5%
Time frame: up to 5 years
Number of patients with improvement or worsening in exocrine function as measured by the estimation of fecal elastase >200 µg/g of stool or <200 µg/g of stool respectively at out patient clinic.
Time frame: up to 5 years
Analgesics intake
Time frame: up to 5 years
Weight gain in kg measured at out patient clinic
Time frame: up to 5 years
Quality of life
Time frame: up to 5 years
Number of patients with worsening in endocrine function as measured by abnormal laboratory values like Fasting glucose >130 and HbA1c >6.5
Time frame: up to 5 years
Number of patients with abnormal lab values like Fasting glucose of >126 mg/dl or blood glucose level of >200 after a standard glucose tolerance test (GTT) in equivocal cases.
Time frame: up to 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2016.
- Individual participant dataSharing planned: Yes. with out showing the name of the participants we can disclose the data of the all participants
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.
KANNAN DEVYGOUNDER, MS,MCh,FRCS study director
MADRAS MEDICAL COLLEGE,CHENNAI,TAMIL NADU,INDIA
BALAKUMARAN SATHYAMOORTHY principal investigator
MADRAS MEDICAL COLLEGE,CHENNAI,TAMIL NADU, INDIA
Questions about this trial
What is this clinical trial studying?
A study testing celiac plexus neurolysis using absolute alcohol and Frey's procedure in people with Chronic Calcific Pancreatitis, run by Madras Medical College.
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 1 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: status not confirmed, as of the sponsor's last update on 12 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
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?
Pain relief measured by Visual Analogue Scale (time frame: up to 5 years). 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 12 Apr 2016.