Pancreas CancerNCT04747600
Outcomes of Surgical Resection of Pancreatic Cystic Neoplasms Based on the European Expert Consensus Statement: A Prospective Observational Study.
An observational study of Pancreas Cancer, run by Zagazig University.
Trial summary
Introduction: Pancreatic cystic neoplasms (PCNs) comprise neoplasms with a wide range of benign and malignant varieties. The most common include serous cystic neoplasms (SCNs), mucinous cystic neoplasms (MCNs), intraductal papillary mucinous neoplasms (IPMNs), and solid pseudo-papillary neoplasms (SPPNs). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pancreas Cancer
- What is being tested?
- surgical resection
- Type of treatment
- Surgery or procedure
- How many people
- 63 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2014to 1 Jan 2021
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: A total of 63 patients with a clinical diagnosis of true exocrine pancreatic cystic neoplasms were enrolled in this prospective cohort study as a comprehensive sampling in our hepato-biliary pancreatic unit of our university hospital between June 2014 to January 2018. They were categorized into 4 groups: Group A(30 patients)that were diagnosed as serous cystic neoplasms, Group B(19 patients) that were diagnosed as mucinous cystic neoplasms, Group C(9 patients )that were diagnosed as intra-ductal papillary mucinous neoplasms and Group D(5 patients ) that were diagnosed as solid pseudo-papillary neoplasms.
Who may be able to join
- any Age
- both sex,
- expected R0 resection,
- Tumor of any size,
- no previous pancreatic surgery with diagnosis of True exocrine pancreatic cystic neoplasms
Who cannot join
- endocrinal pancreatic tumors,
- solid pancreatic tumors,
- previous pancreatic surgery,
- recurrent pancreatic tumor,
- Combined operation,
- prior history of any malignancy and misdiagnosed cases discovered on postoperative pathological cases as pancreatic pseudo-cyst or endocrine tumors
About this study
Introduction: Pancreatic cystic neoplasms (PCNs) comprise neoplasms with a wide range of benign and malignant varieties. The most common include serous cystic neoplasms (SCNs), mucinous cystic neoplasms (MCNs), intraductal papillary mucinous neoplasms (IPMNs), and solid pseudo-papillary neoplasms (SPPNs).
Endoscopic ultrasonography (EUS), computed tomography (CT) and magnetic resonance (MR) are used to diagnose different PCNs types. The cyst fluid aspiration and analysis is performed in difficult differential diagnosis. Frequently, amylase and CEA levels are measured. The choice of surgery depends on cyst location and size and includes pancreatico-duodenectomy or distal pancreatectomy.
Objectives: The aim of this study was to evaluate the outcomes after pancreatic surgery when adopted as the management of true exocrine epithelial cystic neoplasms.
Read the detailed description
Introduction: Pancreatic cystic neoplasms (PCNs) comprise neoplasms with a wide range of benign and malignant varieties. The most common include serous cystic neoplasms (SCNs), mucinous cystic neoplasms (MCNs), intraductal papillary mucinous neoplasms (IPMNs), and solid pseudo-papillary neoplasms (SPPNs).
Endoscopic ultrasonography (EUS), computed tomography (CT) and magnetic resonance (MR) are used to diagnose different PCNs types. The cyst fluid aspiration and analysis is performed in difficult differential diagnosis. Frequently, amylase and CEA levels are measured. The choice of surgery depends on cyst location and size and includes pancreatico-duodenectomy or distal pancreatectomy.
Objectives: The aim of this study was to evaluate the outcomes after pancreatic surgery when adopted as the management of true exocrine epithelial cystic neoplasms.
Patients and methods: Between June 2014 and January 2018, 63 patients referred to our tertiary referral center with diagnosis of true exocrine cystic neoplasms of the pancreas accepted for surgery were included in the present prospective cohort study. Patients were categorized according to preoperative diagnosis into: serous cystic neoplasms (Group A: 30 patients), mucinous cystic neoplasms (Group B: 13 patients), intra-papillary mucinous neoplasms (Group C: 9 patients), whereas the last 5 patients diagnosed as solid pseudo-papillary neoplasms (Group D). Demographic data, perioperative data and univariate analysis for malignancy, recurrence and pancreatic fistula were collected and analyzed.
- Conditions
- Pancreas Cancer
- Being tested
- surgical resection
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgical resectionProcedure or surgery
surgical resection
| Study group | Role | What they receive |
|---|---|---|
| serous cystic neoplasms | Not described Receives: Procedure: surgical resection | |
| mucinous cystic neoplasms | Not described Receives: Procedure: surgical resection | |
| intra-papillary mucinous neoplasms | Not described Receives: Procedure: surgical resection | |
| solid pseudo-papillary neoplasms | Not described Receives: Procedure: surgical resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
the incidence of the pancreatic fistula
detect pancreatic fistula by concentration of amylase level in drain
Measured: 30 days postoperatively
Secondary outcomes (1)
recurrence rate in percentage
rate of recurrence after resection by computed tomography
Measured: 2.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2021
- Study start1 Jun 2014
- Primary completion1 Jan 2018
- Study completion1 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreas CancerStudies of the same condition, open and under way.
- More trials run by Zagazig UniversityThe 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
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Tamer.A.A.M.Habeeb, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04747600
- Sponsor's protocol ID
- zagazig PCN
- Status last verified
- Oct 2022
- First submitted
- 7 Feb 2021
- Last updated
- 10 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Surgical Resection of Pancreatic Cystic Neoplasms Based on the European Expert Consensus Statement: A Prospective Observational Study.
- ClinicalTrials.gov ID
- NCT04747600
- Acronym / sponsor ID
- zagazig PCN
- Conditions
- Pancreas Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 1 Jun 2014 (actual)
- Primary completion
- 1 Jan 2018 (actual)
- Study completion
- 1 Jan 2021 (actual)
- First posted
- 10 Feb 2021 (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.
Introduction: Pancreatic cystic neoplasms (PCNs) comprise neoplasms with a wide range of benign and malignant varieties. The most common include serous cystic neoplasms (SCNs), mucinous cystic neoplasms (MCNs), intraductal papillary mucinous neoplasms (IPMNs), and solid pseudo-papillary neoplasms (SPPNs).
Endoscopic ultrasonography (EUS), computed tomography (CT) and magnetic resonance (MR) are used to diagnose different PCNs types. The cyst fluid aspiration and analysis is performed in difficult differential diagnosis. Frequently, amylase and CEA levels are measured. The choice of surgery depends on cyst location and size and includes pancreatico-duodenectomy or distal pancreatectomy.
Objectives: The aim of this study was to evaluate the outcomes after pancreatic surgery when adopted as the management of true exocrine epithelial cystic neoplasms.
Detailed description
Introduction: Pancreatic cystic neoplasms (PCNs) comprise neoplasms with a wide range of benign and malignant varieties. The most common include serous cystic neoplasms (SCNs), mucinous cystic neoplasms (MCNs), intraductal papillary mucinous neoplasms (IPMNs), and solid pseudo-papillary neoplasms (SPPNs).
Endoscopic ultrasonography (EUS), computed tomography (CT) and magnetic resonance (MR) are used to diagnose different PCNs types. The cyst fluid aspiration and analysis is performed in difficult differential diagnosis. Frequently, amylase and CEA levels are measured. The choice of surgery depends on cyst location and size and includes pancreatico-duodenectomy or distal pancreatectomy.
Objectives: The aim of this study was to evaluate the outcomes after pancreatic surgery when adopted as the management of true exocrine epithelial cystic neoplasms.
Patients and methods: Between June 2014 and January 2018, 63 patients referred to our tertiary referral center with diagnosis of true exocrine cystic neoplasms of the pancreas accepted for surgery were included in the present prospective cohort study. Patients were categorized according to preoperative diagnosis into: serous cystic neoplasms (Group A: 30 patients), mucinous cystic neoplasms (Group B: 13 patients), intra-papillary mucinous neoplasms (Group C: 9 patients), whereas the last 5 patients diagnosed as solid pseudo-papillary neoplasms (Group D). Demographic data, perioperative data and univariate analysis for malignancy, recurrence and pancreatic fistula were collected and analyzed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| serous cystic neoplasms | – | Procedure: surgical resection |
| mucinous cystic neoplasms | – | Procedure: surgical resection |
| intra-papillary mucinous neoplasms | – | Procedure: surgical resection |
| solid pseudo-papillary neoplasms | – | Procedure: surgical resection |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- A total of 63 patients with a clinical diagnosis of true exocrine pancreatic cystic neoplasms were enrolled in this prospective cohort study as a comprehensive sampling in our hepato-biliary pancreatic unit of our university hospital between June 2014 to January 2018. They were categorized into 4 groups: Group A(30 patients)that were diagnosed as serous cystic neoplasms, Group B(19 patients) that were diagnosed as mucinous cystic neoplasms, Group C(9 patients )that were diagnosed as intra-ductal papillary mucinous neoplasms and Group D(5 patients ) that were diagnosed as solid pseudo-papillary neoplasms.
Key inclusion criteria (5 listed)
- any Age
- both sex,
- expected R0 resection,
- Tumor of any size,
- no previous pancreatic surgery with diagnosis of True exocrine pancreatic cystic neoplasms
Key exclusion criteria (6 listed)
- endocrinal pancreatic tumors,
- solid pancreatic tumors,
- previous pancreatic surgery,
- recurrent pancreatic tumor,
- Combined operation,
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 |
|---|---|---|
| surgical resectionsurgical resection | Procedure or surgery | intra-papillary mucinous neoplasms, mucinous cystic neoplasms, serous cystic neoplasms, solid pseudo-papillary neoplasms |
Primary outcome
the incidence of the pancreatic fistula
Time frame: 30 days postoperatively
detect pancreatic fistula by concentration of amylase level in drain
1 secondary outcome
recurrence rate in percentage
Time frame: 2.5 years
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 10 Oct 2022.
- Individual participant dataSharing planned: Undecided
Related trials for Pancreas Cancer
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 1
Modified FOLFIRINOX and Pentamidine in Advanced and Metastatic Pancreatic Cancer
Pancreatic Ductal Adenocarcinoma (PDAC)
RecruitingPhase 3
Atebimetinib + GnP as a First Line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma
Pancreatic Cancer, Pancreatic Cancer Metastatic
RecruitingPhase 3
Lanreotide Versus Placebo Before Surgery to Prevent a Surgical Complication Called a Pancreatic Fistula
Pancreatic Carcinoma, Pancreatic Neoplasm
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreas Cancer, run by Zagazig University.
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 5 inclusion and 6 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 10 Oct 2022. 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?
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?
the incidence of the pancreatic fistula (time frame: 30 days postoperatively). 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 10 Oct 2022.