Clinical Impact of Altitude Level on Surgical Outcomes of Pancreaticoduodenectomy

NCT ID: NCT04401722

Last Updated: 2020-06-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-01

Study Completion Date

2020-04-25

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Periampullary Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
OUTCOME ASESSOR

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

PD in normal altitude

PD underwent in the area at the level of the sea, normal altitude region

Group Type ACTIVE_COMPARATOR

PANCREATICODUDENECTOMY

Intervention Type PROCEDURE

dissection and removal of periampulary tumour with 3 reconstruction PJ, HJ, and GJ

PD in high altitude region.

PD underwent in high altitude region.

Group Type ACTIVE_COMPARATOR

PANCREATICODUDENECTOMY

Intervention Type PROCEDURE

dissection and removal of periampulary tumour with 3 reconstruction PJ, HJ, and GJ

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

PANCREATICODUDENECTOMY

dissection and removal of periampulary tumour with 3 reconstruction PJ, HJ, and GJ

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Whippl,s operation

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* periampulary tumour

Exclusion Criteria

* liver cirrhosis,
* PG,
* advanced tumour,
* vascular resection
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Mansoura University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Ayman El Nakeeb

gastrointestinal surgical center, Mansoura University

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ayman E Nakeeb, MD

Role: PRINCIPAL_INVESTIGATOR

Mansoura University, Gastrointestinal Surgery Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Mahmoud Abd El Wahab

Al Mansurah, , Egypt

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Egypt

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 29961462 (View on PubMed)

El 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.

Reference Type RESULT
PMID: 31461084 (View on PubMed)

El 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.

Reference Type RESULT
PMID: 30413347 (View on PubMed)

Prabhakar 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.

Reference Type RESULT
PMID: 31765479 (View on PubMed)

Study Documents

Access uploaded study-related documents such as protocols, statistical analysis plans, or lay summaries.

Document Type: Study Protocol

through [email protected]

View Document

Related Links

Access external resources that provide additional context or updates about the study.

http://www.mans.edu.eg/en/

Mansoura university

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PD in high altitude

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Surgery for Liver Metastases From PDAC
NCT05271110 NOT_YET_RECRUITING NA