Pancreatic Endocrine NeoplasmsNCT02400996

An Analysis of Presentation and Outcome Following Treatment of Pancreatic Endocrine Neoplasms

An observational study of Pancreatic Endocrine Neoplasms, run by Medical College and Hospital Kolkata.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

A single institutional study of Pancreatic Endocrine Neoplasms over 18 years. Read more about this study

Who is it for?: Any ageHealthy volunteers can take part
Conditions the study is for: Pancreatic Endocrine Neoplasms
How many people: 40 participants
Where: No sites listed yet
Study dates: Mar 2011to Nov 2014
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 Any age
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Study population: Medical files and electronic records were reviewed to collect information. Patients were categorized into functioning and nonfunctioning PENs based on their clinical behaviour, pathology reports and serum radioimmunoassay for offending hormones. Preoperative CT scans were used to characterize PENs and record neoplasm size and location in the pancreas. Review of operative notes was done for the type of surgery performed and peroperative findings recorded. Discharge summaries were used to study the surgical outcome in terms of duration of postoperative hospital stay and postoperative complications. Patients were followed up and any disease recurrence or disease related mortality was recorded. Evaluation of the pathology reports was done.

Who may be able to join

Pathological reports and Prooperative CAT Scan showing Endocrine Pancreatic Tumours

Who cannot join

Nonendocrine Pancreatic Tumours

About this study

Official title: A Single Centre Analysis of Clinical Characteristics and Treatment of Endocrine Pancreatic Tumours.

A single institutional study of Pancreatic Endocrine Neoplasms over 18 years.

Read the detailed description

The investigators did an analysis from a prospectively maintained database of patients who underwent pancreatic resections or nonresective procedures for neoplasms of the pancreas at Sir Ganga Ram Hospital from 1995 to 2013 and using pathological reports and preoperative CT scan as the gold standard, the investigators identified 40 patients with PENs.

Conditions: Pancreatic Endocrine Neoplasms
Keywords: Endocrine Pancreas, Pancreatic Endocrine Neoplasm
Medical subject headings: Adenoma, Islet Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02400996
Study group	Role	What they receive
Pancreatic Endocrine Neoplasms		We did an observational analysis from a prospectively maintained database of patients who underwent pancreatic surgery for neoplasms of the pancreas at Sir Ganga Ram Hospital, New Delhi, India from 1995 to 2013 and using pathological reports and preoperative CT scan as gold standard, we identified 40 patients with PENs.

What is being measured

The primary outcome is the main question the study is designed to answer.

Nonfunctioning and Malignant Pancreatic Endocrine Neoplasms
Of the 40 patients operated for Pancreatic Endocrine Neoplasms, using clinical criteria, histopathological analysis and preoperative imaging as gold standard, nonfunctioning and functioning tumours were identified. Similarly the number of benign and malignant lesions identified were recorded as per the WHO Classification of pancreatic endocrine tumours.
Measured: Each participant was followed up for a period of 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2011Nov 2014

First posted27 Mar 2015 (estimated)
Study startMar 2011
Primary completionJun 2011
Study completionNov 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Pancreatic Endocrine NeoplasmsStudies 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: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02400996
Sponsor's protocol ID: SGRH-SGLT-MTA
Status last verified: Apr 2015
First submitted: 23 Mar 2015
Last updated: 29 Apr 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Vortmeyer AO, Huang S, Lubensky I, Zhuang Z. Non-islet origin of pancreatic islet cell tumors. J Clin Endocrinol Metab. 2004 Apr;89(4):1934-8. doi: 10.1210/jc.2003-031575.
PubMed 15070966
Halfdanarson TR, Rabe KG, Rubin J, Petersen GM. Pancreatic neuroendocrine tumors (PNETs): incidence, prognosis and recent trend toward improved survival. Ann Oncol. 2008 Oct;19(10):1727-33. doi: 10.1093/annonc/mdn351. Epub 2008 May 30.
PubMed 18515795
Kazanjian KK, Reber HA, Hines OJ. Resection of pancreatic neuroendocrine tumors: results of 70 cases. Arch Surg. 2006 Aug;141(8):765-9; discussion 769-70. doi: 10.1001/archsurg.141.8.765.
PubMed 16924083
Vagefi PA, Razo O, Deshpande V, McGrath DJ, Lauwers GY, Thayer SP, Warshaw AL, Fernandez-Del Castillo C. Evolving patterns in the detection and outcomes of pancreatic neuroendocrine neoplasms: the Massachusetts General Hospital experience from 1977 to 2005. Arch Surg. 2007 Apr;142(4):347-54. doi: 10.1001/archsurg.142.4.347.
PubMed 17438169
Heitz PU, Komminoth P, Perrin A et al. Pancreatic endocrine tumors: Introduction. In: DeLellis DA, Lloyd RV, Heitz PU, et al., eds. Pathology and Genetics of Tumours of Endocrine Organs. WHO Classification of Tumours. Lyon, France: IARC Press, 2004: 177-82.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Pancreatic Endocrine Neoplasms trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single Centre Analysis of Clinical Characteristics and Treatment of Endocrine Pancreatic Tumours.
ClinicalTrials.gov ID: NCT02400996
Acronym / sponsor ID: SGRH-SGLT-MTA
Conditions: Pancreatic Endocrine Neoplasms
Keywords: Endocrine Pancreas, Pancreatic Endocrine Neoplasm
Study type: Observational
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Medical College and Hospital KolkataUniversity, hospital or other
Collaborators: Sir Ganga Ram Hospital
Study start: Mar 2011
Primary completion: Jun 2011 (actual)
Study completion: Nov 2014 (actual)
First posted: 27 Mar 2015 (estimated)
Results: Posted 29 Apr 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

A single institutional study of Pancreatic Endocrine Neoplasms over 18 years.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Pancreatic Endocrine Neoplasms	–	–We did an observational analysis from a prospectively maintained database of patients who underwent pancreatic surgery for neoplasms of the pancreas at Sir Ganga Ram Hospital, New Delhi, India from 1995 to 2013 and using pathological reports and preoperative CT scan as gold standard, we identified 40 patients with PENs.

Who may qualify

Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult
Study population: Medical files and electronic records were reviewed to collect information. Patients were categorized into functioning and nonfunctioning PENs based on their clinical behaviour, pathology reports and serum radioimmunoassay for offending hormones. Preoperative CT scans were used to characterize PENs and record neoplasm size and location in the pancreas. Review of operative notes was done for the type of surgery performed and peroperative findings recorded. Discharge summaries were used to study the surgical outcome in terms of duration of postoperative hospital stay and postoperative complications. Patients were followed up and any disease recurrence or disease related mortality was recorded. Evaluation of the pathology reports was done.

Key inclusion criteria (1 listed)

Pathological reports and Prooperative CAT Scan showing Endocrine Pancreatic Tumours

Key exclusion criteria (1 listed)

Nonendocrine Pancreatic Tumours

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

Nonfunctioning and Malignant Pancreatic Endocrine Neoplasms
Time frame: Each participant was followed up for a period of 5 years
Of the 40 patients operated for Pancreatic Endocrine Neoplasms, using clinical criteria, histopathological analysis and preoperative imaging as gold standard, nonfunctioning and functioning tumours were identified. Similarly the number of benign and malignant lesions identified were recorded as per the WHO Classification of pancreatic endocrine tumours.

Results and safety

Results posted to the registry on 29 Apr 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Patients Operated for Pancreatic Endocrine Neoplasms	40	40

Primary outcome: Nonfunctioning and Malignant Pancreatic Endocrine Neoplasms

Time frame: Each participant was followed up for a period of 5 years. Number. Unit: participants

Measure	Patients Operated for Pancreatic Endocrine Neoplasms n = 40
Nonfunctioning Tumours	28
Functioning Tumours	12
Benign Tumours	22
Malignant Tumours	18

Adverse events

Time frame: Complications were noted within the hospital admission. Postoperative mortality recorded as death within the same hospital admission or within 30 days of surgery. Follow up was done at 3 and 6 months and then at 6 monthly intervals for 5 years.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pancreatic Endocrine Neoplasms	6 of 40 (15%)	16 of 40 (40%)	Not reported

Limitations and caveats (from the sponsor): The analysis was done from a prospectively maintained database and target followup done for a period of 5 years after surgery

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 15070966Vortmeyer AO, Huang S, Lubensky I, Zhuang Z. Non-islet origin of pancreatic islet cell tumors. J Clin Endocrinol Metab. 2004 Apr;89(4):1934-8. doi: 10.1210/jc.2003-031575.
Background: PubMed 18515795Halfdanarson TR, Rabe KG, Rubin J, Petersen GM. Pancreatic neuroendocrine tumors (PNETs): incidence, prognosis and recent trend toward improved survival. Ann Oncol. 2008 Oct;19(10):1727-33. doi: 10.1093/annonc/mdn351. Epub 2008 May 30.
Results publication: PubMed 16924083Kazanjian KK, Reber HA, Hines OJ. Resection of pancreatic neuroendocrine tumors: results of 70 cases. Arch Surg. 2006 Aug;141(8):765-9; discussion 769-70. doi: 10.1001/archsurg.141.8.765.
Results publication: PubMed 17438169Vagefi PA, Razo O, Deshpande V, McGrath DJ, Lauwers GY, Thayer SP, Warshaw AL, Fernandez-Del Castillo C. Evolving patterns in the detection and outcomes of pancreatic neuroendocrine neoplasms: the Massachusetts General Hospital experience from 1977 to 2005. Arch Surg. 2007 Apr;142(4):347-54. doi: 10.1001/archsurg.142.4.347.
Results publicationHeitz PU, Komminoth P, Perrin A et al. Pancreatic endocrine tumors: Introduction. In: DeLellis DA, Lloyd RV, Heitz PU, et al., eds. Pathology and Genetics of Tumours of Endocrine Organs. WHO Classification of Tumours. Lyon, France: IARC Press, 2004: 177-82.

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RecruitingPhase 3
Lanreotide Versus Placebo Before Surgery to Prevent a Surgical Complication Called a Pancreatic Fistula
Pancreatic Carcinoma, Pancreatic Neoplasm
RecruitingPhase 3
Study of Zoldonrasib + Chemo of Investigator's Choice vs Placebo + Chemo of Investigator's Choice as First-line Treatment in Metastatic KRAS G12D-mutated Pancreatic Adenocarcinoma ( RASolute 305 )
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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.

Md Tanveer Adil principal investigator

Sir Ganga Ram Hospital, New Delhi

Raghavendra Nagaraja study director

Sir Ganga Ram Hospital, New Delhi

Vibha Varma study director

Sir Ganga Ram Hospital, New Delhi

Questions about this trial

What is this clinical trial studying?

An observational study of Pancreatic Endocrine Neoplasms, run by Medical College and Hospital Kolkata.

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: finished, as of the sponsor's last update on 29 Apr 2015. 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. 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?

Yes. Results are posted in the registry (first posted 29 Apr 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Nonfunctioning and Malignant Pancreatic Endocrine Neoplasms (time frame: Each participant was followed up for a period of 5 years). 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 NCT02400996, which also lists 5 linked publications.

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 29 Apr 2015.