Whipple ProcedureNCT03820583
Whipple Procedure: A 5-year Clinical Experience in Tertiary Care Center
A study testing Whipple Procedure in people with Whipple Procedure, run by Services Hospital, Lahore at 1 site in Pakistan.
Trial summary
The study was conducted in tertiary care hospital of Lahore. Patient undergoing Whipple procedure were studied by compiling demographic details of the patients, common presenting symptoms, various indications for Whipple's procedure, the cofactors which affect the procedures outcome and morbidity and mortality of the… Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Whipple Procedure
- What is being tested?
- Whipple Procedure
- Type of treatment
- Surgery or procedure
- How many people
- 57 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jan 2014to 31 Dec 2018
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients of both sexes with age ranging from 20 years to 70 years
- patients with pancreatic tumors
- patients with adequate cardiorespiratory reserves to be fit for prolong general anesthesia
Who cannot join
- unresectable tumors
- unfit for surgery
Trial locations and contacts
1 site in 1 country.
About this study
The study was conducted in tertiary care hospital of Lahore. Patient undergoing Whipple procedure were studied by compiling demographic details of the patients, common presenting symptoms, various indications for Whipple's procedure, the cofactors which affect the procedures outcome and morbidity and mortality of the patients.
Read the detailed description
This study was performed by collecting data through predesigned questionnaire about patients undergoing Whipple's procedure from operation theatres and medical record section. Those patients, whose tumor was unresectable and undergone palliative surgical procedures were excluded from the study.
- Conditions
- Whipple Procedure
- Being tested
- Whipple Procedure
- Keywords
- Whipple procedure, pancreatic carcinoma, biliary stenting,
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whipple ProcedureProcedure or surgery
Patients underwent Whipple procedure for pancreatic tumors. The procedure commenced with rooftop incision. then layers of abdomen dissected to reach the peritoneum. Then Duodenum dissected out along with pancreas and common bile duct. After rescetion of these structures the anatomy of the tract restored with three anastomosis namely pancreaticojejunostomy, gastrojejunostomy and choledochojejunostomy/hepaticojejunostomy.
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients developing pancreatic fistula
Percentage of patients developing pancreatic fistula (pancreatic juice collected in drain rich in amylase) after Whipple procedure Enteric leak postoperative complications like pancreatic fistula, anastomotic leakage, hemorrhage, wound infection,mortality
Measured: 4 weeks
Percentage of patients developing hemorrhage
Percentage of patients developing hemorrhage after Whipple procedure
Measured: 2 weeks
Percentage of patients developing wound infection
Percentage of patients developing wound infection after Whipple procedure
Measured: 4 weeks
Mortality rate
Mortality of patients undergoing Whipple surgery
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2019
- Study start1 Jan 2014
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Whipple ProcedureStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Patients undergoing Whipple procedure due to pancreatic tumor were included in the study
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Services Hospital, Lahore
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr. SamiUllah, Services Hospital, Lahore
- Investigators
- Mahmmood Ayyaz, mbbs, fcps, Study director, Services Hospital, Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03820583
- Sponsor's protocol ID
- s11
- Status last verified
- Jan 2019
- First submitted
- 25 Jan 2019
- Last updated
- 31 Jan 2019
- Results posted
- 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 31 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Whipple Procedure: A 5-year Clinical Experience in Tertiary Care Center
- ClinicalTrials.gov ID
- NCT03820583
- Acronym / sponsor ID
- s11
- Conditions
- Whipple Procedure
- Keywords
- Whipple procedure, pancreatic carcinoma, biliary stenting,
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Services Hospital, LahoreOther government
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 29 Jan 2019 (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.
The study was conducted in tertiary care hospital of Lahore. Patient undergoing Whipple procedure were studied by compiling demographic details of the patients, common presenting symptoms, various indications for Whipple's procedure, the cofactors which affect the procedures outcome and morbidity and mortality of the patients.
Detailed description
This study was performed by collecting data through predesigned questionnaire about patients undergoing Whipple's procedure from operation theatres and medical record section. Those patients, whose tumor was unresectable and undergone palliative surgical procedures were excluded from the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Model description
- Patients undergoing Whipple procedure due to pancreatic tumor were included in the study
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients of both sexes with age ranging from 20 years to 70 years
- patients with pancreatic tumors
- patients with adequate cardiorespiratory reserves to be fit for prolong general anesthesia
Key exclusion criteria (2 listed)
- unresectable tumors
- unfit for surgery
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 |
|---|---|---|
| Whipple ProcedurePatients underwent Whipple procedure for pancreatic tumors. The procedure commenced with rooftop incision. then layers of abdomen dissected to reach the peritoneum. Then Duodenum dissected out along with pancreas and common bile duct. After rescetion of these structures the anatomy of the tract restored with three anastomosis namely pancreaticojejunostomy, gastrojejunostomy and choledochojejunostomy/hepaticojejunostomy. | Procedure or surgery | – |
Primary outcome
Percentage of patients developing pancreatic fistula
Time frame: 4 weeks
Percentage of patients developing pancreatic fistula (pancreatic juice collected in drain rich in amylase) after Whipple procedure Enteric leak postoperative complications like pancreatic fistula, anastomotic leakage, hemorrhage, wound infection,mortality
Percentage of patients developing hemorrhage
Time frame: 2 weeks
Percentage of patients developing hemorrhage after Whipple procedure
Percentage of patients developing wound infection
Time frame: 4 weeks
Percentage of patients developing wound infection after Whipple procedure
Mortality rate
Time frame: 6 weeks
Mortality of patients undergoing Whipple 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 31 Jan 2019.
- Individual participant dataSharing planned: Undecided
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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.
Mahmmood Ayyaz, mbbs, fcps study director
Services Hospital, Lahore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whipple Procedure in people with Whipple Procedure, run by Services Hospital, Lahore 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 3 inclusion and 2 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 31 Jan 2019. 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?
Percentage of patients developing pancreatic fistula (time frame: 4 weeks). The study lists 4 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 31 Jan 2019.