Periampullary CancerPDNCT04401722
Clinical Impact of Altitude Level on Surgical Outcomes of Pancreaticoduodenectomy
A study testing PANCREATICODUDENECTOMY in people with Periampullary Cancer, run by Mansoura University at 1 site in Egypt.
Trial summary
Very few papers examine the effect of living at high altitudes on surgical results of major operations. This research is designed to determine the surgical outcomes of PD for periampullary tumour in high altitudes and normal altitudes. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Periampullary Cancer
- What is being tested?
- PANCREATICODUDENECTOMY
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2018to 25 Apr 2020
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- periampulary tumour
Who cannot join
- liver cirrhosis,
- PG,
- advanced tumour,
- vascular resection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Impact of Altitude Level on Surgical Outcomes of Pancreaticoduodenectomy for Periampullary Tumour (Multicenter Study)
Very few papers examine the effect of living at high altitudes on surgical results of major operations. This research is designed to determine the surgical outcomes of PD for periampullary tumour in high altitudes and normal altitudes.
Read the detailed description
Many recent studies have suggested multiple risk factors affecting postoperative surgical outcomes of PD; THE research is designed to determine the surgical outcomes of PD for periampullary tumour in high altitudes and normal altitude.
it is a multicenter study Aseer central hospital, Saudia and from Egypt two centers Mansoura university and el Menia university
- Conditions
- Periampullary Cancer
- Being tested
- PANCREATICODUDENECTOMY
- Keywords
- pancreaticodudenctomy, POPF, HIGH ALTITUDE
- Medical subject headings
- Altitude Sickness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PANCREATICODUDENECTOMYProcedure or surgery
Also called Whippl,s operation
dissection and removal of periampulary tumour with 3 reconstruction PJ, HJ, and GJ
| Study group | Role | What they receive |
|---|---|---|
| PD in normal altitude | Active comparator | PD underwent in the area at the level of the sea, normal altitude region Receives: Procedure: PANCREATICODUDENECTOMY |
| PD in high altitude region. | Active comparator | PD underwent in high altitude region. Receives: Procedure: PANCREATICODUDENECTOMY |
What is being measured
The primary outcome is the main question the study is designed to answer.
the overall postoperative complications
the overall postoperative complications
Measured: 30 DAYS
Secondary outcomes (3)
blood loss
blood loss
Measured: INTRAOPERATIVE
Pulmonary embolism (PE)
Pulmonary embolism (PE)
Measured: 30 days
hospital mortality
death within 30 days of operation
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2020
- Study start1 Mar 2018
- Primary completion1 Apr 2020
- Study completion25 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Periampullary CancerStudies of the same condition, open and under way.
- More trials run by Mansoura 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- it is a multicenter study Aseer centeral hospital, saudia and from Egypt two centers mansoura university and el menia university The patients distributed into two groups group I (G1) PD underwent in the area at the level of the sea, normal altitude region, and group II (G2) PD underwent in high altitude region.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayman El Nakeeb, Mansoura University
- Investigators
- Ayman E Nakeeb, MD, Principal investigator, Mansoura University, Gastrointestinal Surgery Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04401722
- Sponsor's protocol ID
- PD in high altitude
- Acronym
- PD
- Status last verified
- Jun 2020
- First submitted
- 21 May 2020
- Last updated
- 9 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: it will be available for other researchers
Publications
Dutta V, Singh R, Kumar S, Aggarwal N, Hari Kumar KVS. Profile of pulmonary embolism in service personnel posted at high altitude area. Indian Heart J. 2018 May-Jun;70(3):427-429. doi: 10.1016/j.ihj.2017.08.002. Epub 2017 Aug 18.
PubMed 29961462El Nakeeb A, Attia M, El Sorogy M, Ezzat H, Shehta A, Salem A, El Gawad MA, Hamed H, Allah TA, El-Geidi AA, Fathy O, El Hefnawy E, Zaghloul A. Laparoscopic Pancreaticodudenectomy for Periampullary Tumor: Should it be a Routine? A Propensity Score-matched Study. Surg Laparosc Endosc Percutan Tech. 2020 Feb;30(1):7-13. doi: 10.1097/SLE.0000000000000715.
PubMed 31461084El Nakeeb A, El Sorogy M, Hamed H, Said R, Elrefai M, Ezzat H, Askar W, Elsabbagh AM. Biliary leakage following pancreaticoduodenectomy: Prevalence, risk factors and management. Hepatobiliary Pancreat Dis Int. 2019 Feb;18(1):67-72. doi: 10.1016/j.hbpd.2018.10.005. Epub 2018 Oct 28.
PubMed 30413347Prabhakar A, Chatterjee T, Bajaj N, Tyagi T, Sahu A, Gupta N, Kumari B, Nair V, Kumar B, Ashraf MZ. Venous thrombosis at altitude presents with distinct biochemical profiles: a comparative study from the Himalayas to the plains. Blood Adv. 2019 Nov 26;3(22):3713-3723. doi: 10.1182/bloodadvances.2018024554.
PubMed 31765479
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Impact of Altitude Level on Surgical Outcomes of Pancreaticoduodenectomy for Periampullary Tumour (Multicenter Study)
- ClinicalTrials.gov ID
- NCT04401722
- Acronym / sponsor ID
- PD / PD in high altitude
- Conditions
- Periampullary Cancer
- Keywords
- pancreaticodudenctomy, POPF, HIGH ALTITUDE
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 1 Apr 2020 (actual)
- Study completion
- 25 Apr 2020 (actual)
- First posted
- 26 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.
Very few papers examine the effect of living at high altitudes on surgical results of major operations. This research is designed to determine the surgical outcomes of PD for periampullary tumour in high altitudes and normal altitudes.
Detailed description
Many recent studies have suggested multiple risk factors affecting postoperative surgical outcomes of PD; THE research is designed to determine the surgical outcomes of PD for periampullary tumour in high altitudes and normal altitude.
it is a multicenter study Aseer central hospital, Saudia and from Egypt two centers Mansoura university and el Menia university
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- it is a multicenter study Aseer centeral hospital, saudia and from Egypt two centers mansoura university and el menia university The patients distributed into two groups group I (G1) PD underwent in the area at the level of the sea, normal altitude region, and group II (G2) PD underwent in high altitude region.
| Arm | Type | Receives |
|---|---|---|
| PD in normal altitude | Active comparator | Procedure: PANCREATICODUDENECTOMYPD underwent in the area at the level of the sea, normal altitude region |
| PD in high altitude region. | Active comparator | Procedure: PANCREATICODUDENECTOMYPD underwent in high altitude region. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- periampulary tumour
Key exclusion criteria (4 listed)
- liver cirrhosis,
- PG,
- advanced tumour,
- vascular resection
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 |
|---|---|---|
| PANCREATICODUDENECTOMYAlso: Whippl,s operationdissection and removal of periampulary tumour with 3 reconstruction PJ, HJ, and GJ | Procedure or surgery | PD in high altitude region., PD in normal altitude |
Primary outcome
the overall postoperative complications
Time frame: 30 DAYS
the overall postoperative complications
3 secondary outcomes
blood loss
Time frame: INTRAOPERATIVE
Pulmonary embolism (PE)
Time frame: 30 days
hospital mortality
Time frame: 30 days
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 9 Jun 2020.
- Background: PubMed 29961462Dutta V, Singh R, Kumar S, Aggarwal N, Hari Kumar KVS. Profile of pulmonary embolism in service personnel posted at high altitude area. Indian Heart J. 2018 May-Jun;70(3):427-429. doi: 10.1016/j.ihj.2017.08.002. Epub 2017 Aug 18.
- Results publication: PubMed 31461084El Nakeeb A, Attia M, El Sorogy M, Ezzat H, Shehta A, Salem A, El Gawad MA, Hamed H, Allah TA, El-Geidi AA, Fathy O, El Hefnawy E, Zaghloul A. Laparoscopic Pancreaticodudenectomy for Periampullary Tumor: Should it be a Routine? A Propensity Score-matched Study. Surg Laparosc Endosc Percutan Tech. 2020 Feb;30(1):7-13. doi: 10.1097/SLE.0000000000000715.
- Results publication: PubMed 30413347El Nakeeb A, El Sorogy M, Hamed H, Said R, Elrefai M, Ezzat H, Askar W, Elsabbagh AM. Biliary leakage following pancreaticoduodenectomy: Prevalence, risk factors and management. Hepatobiliary Pancreat Dis Int. 2019 Feb;18(1):67-72. doi: 10.1016/j.hbpd.2018.10.005. Epub 2018 Oct 28.
- Results publication: PubMed 31765479Prabhakar A, Chatterjee T, Bajaj N, Tyagi T, Sahu A, Gupta N, Kumari B, Nair V, Kumar B, Ashraf MZ. Venous thrombosis at altitude presents with distinct biochemical profiles: a comparative study from the Himalayas to the plains. Blood Adv. 2019 Nov 26;3(22):3713-3723. doi: 10.1182/bloodadvances.2018024554.
- Mansoura universityLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. it will be available for other researchers
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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.
Ayman E Nakeeb, MD principal investigator
Mansoura University, Gastrointestinal Surgery Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PANCREATICODUDENECTOMY in people with Periampullary Cancer, run by Mansoura University at 1 site in Egypt.
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 4 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 9 Jun 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 Egypt. 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?
the overall postoperative complications (time frame: 30 DAYS). 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 NCT04401722, which also lists 4 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 9 Jun 2020.