Pancreatic CancerNCT04395898
Pancreaticoduodenectomy: Outcomes of a Complex Surgical Procedure From a Developing Country
An observational study of Pancreatic Cancer, run by Shaukat Khanum Memorial Cancer Hospital & Research Centre at 1 site in Pakistan.
Trial summary
ABSTRACT BACKGROUND Pancreaticoduodenectomy (PD) plays an integral part in the management of pancreatic, periampullary and duodenal cancers along with few other pathologies of this region. Despite advances in surgery PD continues to have significant morbidity and noteworthy mortality. Read more about this study
- Who is it for?
- Ages 19 to 78 years
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- pancreaticoduodenectomy
- Type of treatment
- Surgery or procedure
- How many people
- 161 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jan 2020to 15 Mar 2020
- 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 19 to 78 years
- All sexes
- Adult, Older adult
Study population: Pancreatic cancer.
Who may be able to join
- all patients whose surgeries were done from January 2014 to March 2019
Who cannot join
- None as such
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Shaukat Khanam Memorial Cancer Hospital and Research Center
Lahore, Punjab Province, 54000
About this study
ABSTRACT
BACKGROUND Pancreaticoduodenectomy (PD) plays an integral part in the management of pancreatic, periampullary and duodenal cancers along with few other pathologies of this region. Despite advances in surgery PD continues to have significant morbidity and noteworthy mortality. The aim of this study is to provide an in-depth report on the patient characteristics, indications and the outcomes of PD) in a tertiary cancer hospital in Pakistan.
Read more
MATERIALS AND METHODS:
The study population included patients who underwent PD between January 1st 2014 and march 31st 2019, at Shaukat Khanum Memorial Cancer Hospital and Research Centre (SKMCH\&RC) in Pakistan. The Data was retrospectively analyzed from the Hospital Information System (HIS), which is a prospectively maintained patient electronic database of SKMCH\&RC. Patient characteristics, procedural details and post-operative outcomes according to internationally accepted definitions were reported.
KEYWORDS: Whipple's procedure, Pancreaticoduodenectomy, Pancreaticogastrostomy, lower middle income, pancreatic fistula, periampullary cancer.
Read the detailed description
INTRODUCTION:
Pancreatic cancer is one of the most common cancer worldwide and ranks 7th as the leading cause of death among all cancers.The estimated 5 year survival of pancreatic cancer is very poor i.e. 5%. Apart from cancer there is a plethora of benign and pre-malignant pancreatic lesions that can manifest symptoms in patients.
Surgery plays an integral part in the management of pancreatic lesions. Pancreaticoduodenectomy (PD) is a considered to be one of the most complex and morbid surgical procedures. The first case series published by Allan Whipple in 1935 reported the procedure related mortality in excess of 25 percent. With the advancements in surgical techniques, perioperative and critical care management, mortality rate has dropped down to less than 5 percent in high volume centers. However, morbidity remains high with some studies reporting up to 70 percent .
There have been some studies, with small cohort and limited follow up periods, reporting on outcomes of PD in Pakistan .To our knowledge, no published study has focused on detailed surgical outcomes and long term follow up. We do not know the long term outcomes after PD in Pakistan and most information is based on a western literature which may not be applicable to a Pakistani cohort of patients. SKMCH\&RC being a dedicated cancer centre and tertiary care hospital of the country receives a high number of referrals of patients requiring this complex procedure in Pakistan.
Every patient that is referred to our hospital has a detailed history and examination in the walk-in clinic. Every case undergoes a pancreatic protocol Computerised Tomograph scan(CT) and where appropriate interventions like Endoscopic Retrograde Cholangiography (ERCP) with or without stent placement, Endoscopic Ultra-sound or Percutaneous Trans-hepatic Cholangiogram (PTC) are undertaken. Every case is discussed in our Multi-Disciplinary Team (MDT) meeting comprising of trained hepatobiliary surgeons, gastroenterologists, diagnostic and interventional radiologists, pathologists, medical and radiation oncologists. Patients with border-line operable confirmed pancreatic cancers undergo neo-adjuvant treatment, whereas resectable lesions undergo upfront PD.investigators work at a paperless hospital and all patient data is put real time into a computerised Hospital Information System (HIS) by all cadres including nurses, allied health professionals and doctors. The hospital has a unique in-house developed computerised patient management system (HIS) that collects all patient information in real time including patient demographics, investigations, Multi-Disciplinary Team discussions, Nursing assessments, outpatient, operative notes and post- operative outcomes. As the data is collected in real time and stored, it allows for accurate retrospective review of the data.
The aim of this study is to provide a detailed analysis of the patient characteristics, indications, post-operative and intermediate term outcomes for PD in a Pakistani cohort of patients. This will provide a reference point for physicians when they counsel their patients regarding PD outcomes in Pakistan and also help define areas of potential improvement in the future.
METHODOLOGY:
Patients:
All patients undergoing PD from 1st January 2014 till 31st March 2019 at SKMCH\&RC, Pakistan were retrospectively evaluated from a prospectively maintained database using the HIS system. The cohort of patients selected included malignant, pre-malignant and benign pathologies. Exclusion criteria included patients that did not undergo PD after exploratory laparotomy due to metastatic disease or with involvement of celiac, superior mesenteric or hepatic arteries. The ethical approval was sought from Institutional Review Board (IRB) of SKMCH \& RC vide number EX-24-10-19-01.
Variables:
Variables recorded were age, gender, co-morbidities, American-Society of Anesthesiologists score (ASA), pre-operative histopathology, clinical staging, surgical details, post-operative complications, mortality (30 \& 90 day), length of stay, and survival outcomes.
Pancreatic fistula was recorded as defined by ISGPF 2016 updated criteria. Post-Pancreatectomy Hemorrhage (PPH) was recorded as defined by International Study Group on Pancreatic Surgery (ISGPS) 2007 classification. Morbidity was recorded according to Clavien-Dindo classification.
Statistical analyses:
Calculations were performed with Statistical Package for the Social Sciences (SPSS Ver20) for Windows. Data was described using median with minimum and maximum value for skewly distributed quantitative variables. For categorical variables, number of observations and percentages were reported. For survival analyses Kaplan-Miere Curve was applied. The study is in compliance with the SKMCH\&RC guidelines on research involving human subjects.
ETHICAL APPROVAL:
Ethical approval was obtained from Institutional Review Board (IRB) of Shaukat Khanum Memorial Cancer Hospital and Research Centre, prior to the commencement of study.
PATIENTS' CONSENT:
Informed consent was taken from every patient about data collection, analysis and research publication.
DECLARATIONS OF INTEREST:
None
FUNDING:
The research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.
- Conditions
- Pancreatic Cancer
- Being tested
- pancreaticoduodenectomy
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pancreaticoduodenectomyProcedure or surgery
Whipple's procedure
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival analysis
disease free and overall survival
Measured: 4 years
Secondary outcomes (2)
Morbidity
morbidity was defined according to Clavien-Dindo classification
Measured: 30 days
recurrence
recurrence is defined as return of the cancer after initial curative or definitive treatment, can be local or distant
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2020
- Study start1 Jan 2020
- Primary completion4 Mar 2020
- Study completion15 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies 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
- Retrospective
- Enrolment
- 161 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shaukat Khanum Memorial Cancer Hospital & Research Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, aun jamal, Shaukat Khanum Memorial Cancer Hospital & Research Centre
- Investigators
- Farah Rasheed, Study director, Clinical research officer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04395898
- Sponsor's protocol ID
- EX-24-10-19-01
- Status last verified
- May 2020
- First submitted
- 11 May 2020
- Last updated
- 20 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: will see
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pancreaticoduodenectomy: Outcomes of a Complex Surgical Procedure From a Developing Country
- ClinicalTrials.gov ID
- NCT04395898
- Acronym / sponsor ID
- EX-24-10-19-01
- Conditions
- Pancreatic Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- Shaukat Khanum Memorial Cancer Hospital & Research CentreUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 4 Mar 2020 (actual)
- Study completion
- 15 Mar 2020 (actual)
- First posted
- 20 May 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.
ABSTRACT
BACKGROUND Pancreaticoduodenectomy (PD) plays an integral part in the management of pancreatic, periampullary and duodenal cancers along with few other pathologies of this region. Despite advances in surgery PD continues to have significant morbidity and noteworthy mortality. The aim of this study is to provide an in-depth report on the patient characteristics, indications and the outcomes of PD) in a tertiary cancer hospital in Pakistan.
MATERIALS AND METHODS:
The study population included patients who underwent PD between January 1st 2014 and march 31st 2019, at Shaukat Khanum Memorial Cancer Hospital and Research Centre (SKMCH\&RC) in Pakistan. The Data was retrospectively analyzed from the Hospital Information System (HIS), which is a prospectively maintained patient electronic database of SKMCH\&RC. Patient characteristics, procedural details and post-operative outcomes according to internationally accepted definitions were reported.
KEYWORDS: Whipple's procedure, Pancreaticoduodenectomy, Pancreaticogastrostomy, lower middle income, pancreatic fistula, periampullary cancer.
Detailed description
INTRODUCTION:
Pancreatic cancer is one of the most common cancer worldwide and ranks 7th as the leading cause of death among all cancers.The estimated 5 year survival of pancreatic cancer is very poor i.e. 5%. Apart from cancer there is a plethora of benign and pre-malignant pancreatic lesions that can manifest symptoms in patients.
Surgery plays an integral part in the management of pancreatic lesions. Pancreaticoduodenectomy (PD) is a considered to be one of the most complex and morbid surgical procedures. The first case series published by Allan Whipple in 1935 reported the procedure related mortality in excess of 25 percent. With the advancements in surgical techniques, perioperative and critical care management, mortality rate has dropped down to less than 5 percent in high volume centers. However, morbidity remains high with some studies reporting up to 70 percent .
There have been some studies, with small cohort and limited follow up periods, reporting on outcomes of PD in Pakistan .To our knowledge, no published study has focused on detailed surgical outcomes and long term follow up. We do not know the long term outcomes after PD in Pakistan and most information is based on a western literature which may not be applicable to a Pakistani cohort of patients. SKMCH\&RC being a dedicated cancer centre and tertiary care hospital of the country receives a high number of referrals of patients requiring this complex procedure in Pakistan.
Every patient that is referred to our hospital has a detailed history and examination in the walk-in clinic. Every case undergoes a pancreatic protocol Computerised Tomograph scan(CT) and where appropriate interventions like Endoscopic Retrograde Cholangiography (ERCP) with or without stent placement, Endoscopic Ultra-sound or Percutaneous Trans-hepatic Cholangiogram (PTC) are undertaken. Every case is discussed in our Multi-Disciplinary Team (MDT) meeting comprising of trained hepatobiliary surgeons, gastroenterologists, diagnostic and interventional radiologists, pathologists, medical and radiation oncologists. Patients with border-line operable confirmed pancreatic cancers undergo neo-adjuvant treatment, whereas resectable lesions undergo upfront PD.investigators work at a paperless hospital and all patient data is put real time into a computerised Hospital Information System (HIS) by all cadres including nurses, allied health professionals and doctors. The hospital has a unique in-house developed computerised patient management system (HIS) that collects all patient information in real time including patient demographics, investigations, Multi-Disciplinary Team discussions, Nursing assessments, outpatient, operative notes and post- operative outcomes. As the data is collected in real time and stored, it allows for accurate retrospective review of the data.
The aim of this study is to provide a detailed analysis of the patient characteristics, indications, post-operative and intermediate term outcomes for PD in a Pakistani cohort of patients. This will provide a reference point for physicians when they counsel their patients regarding PD outcomes in Pakistan and also help define areas of potential improvement in the future.
METHODOLOGY:
Patients:
All patients undergoing PD from 1st January 2014 till 31st March 2019 at SKMCH\&RC, Pakistan were retrospectively evaluated from a prospectively maintained database using the HIS system. The cohort of patients selected included malignant, pre-malignant and benign pathologies. Exclusion criteria included patients that did not undergo PD after exploratory laparotomy due to metastatic disease or with involvement of celiac, superior mesenteric or hepatic arteries. The ethical approval was sought from Institutional Review Board (IRB) of SKMCH \& RC vide number EX-24-10-19-01.
Variables:
Variables recorded were age, gender, co-morbidities, American-Society of Anesthesiologists score (ASA), pre-operative histopathology, clinical staging, surgical details, post-operative complications, mortality (30 \& 90 day), length of stay, and survival outcomes.
Pancreatic fistula was recorded as defined by ISGPF 2016 updated criteria. Post-Pancreatectomy Hemorrhage (PPH) was recorded as defined by International Study Group on Pancreatic Surgery (ISGPS) 2007 classification. Morbidity was recorded according to Clavien-Dindo classification.
Statistical analyses:
Calculations were performed with Statistical Package for the Social Sciences (SPSS Ver20) for Windows. Data was described using median with minimum and maximum value for skewly distributed quantitative variables. For categorical variables, number of observations and percentages were reported. For survival analyses Kaplan-Miere Curve was applied. The study is in compliance with the SKMCH\&RC guidelines on research involving human subjects.
ETHICAL APPROVAL:
Ethical approval was obtained from Institutional Review Board (IRB) of Shaukat Khanum Memorial Cancer Hospital and Research Centre, prior to the commencement of study.
PATIENTS' CONSENT:
Informed consent was taken from every patient about data collection, analysis and research publication.
DECLARATIONS OF INTEREST:
None
FUNDING:
The research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 19 to 78 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Pancreatic cancer.
Key inclusion criteria (1 listed)
- all patients whose surgeries were done from January 2014 to March 2019
Key exclusion criteria (1 listed)
- None as such
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 |
|---|---|---|
| pancreaticoduodenectomyWhipple's procedure | Procedure or surgery | – |
Primary outcome
Survival analysis
Time frame: 4 years
disease free and overall survival
2 secondary outcomes
Morbidity
Time frame: 30 days
recurrence
Time frame: 4 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 20 May 2020.
- Individual participant dataSharing planned: Yes. will see
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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.
Farah Rasheed study director
Clinical research officer
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 Pancreatic Cancer, run by Shaukat Khanum Memorial Cancer Hospital & Research Centre at 1 site in Pakistan.
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 20 May 2020. 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 Pakistan. 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?
Survival analysis (time frame: 4 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 20 May 2020; AzTrials last refreshed its copy on 7 Nov 2026.