Clinical Impact of Altitude Level on Surgical Outcomes of Pancreaticoduodenectomy

Periampullary Cancer Clinical Trial

— PD  

Official title:

Clinical Impact of Altitude Level on Surgical Outcomes of Pancreaticoduodenectomy for Periampullary Tumour (Multicenter Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04401722
• Other study ID #: PD in high altitude
• Status: Completed
• Phase: N/A
• Start date: March 1, 2018
• Est. completion date: April 25, 2020

Study information

• Verified date: June 2020
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: April 25, 2020
• Est. primary completion date: April 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• periampulary tumour

Exclusion Criteria:

• liver cirrhosis,

• PG,

• advanced tumour,

• vascular resection

Related Conditions & MeSH terms

• Periampullary Cancer

Intervention

Procedure:
• PANCREATICODUDENECTOMY
dissection and removal of periampulary tumour with 3 reconstruction PJ, HJ, and GJ

Locations

Country	Name	City	State
Egypt	Mahmoud Abd El Wahab	Mansoura

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

References & Publications (4)

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. — View Citation

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 — View Citation

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.201 — View Citation

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(2 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the overall postoperative complications	the overall postoperative complications	30 DAYS
Secondary	blood loss	blood loss	INTRAOPERATIVE
Secondary	Pulmonary embolism (PE)	Pulmonary embolism (PE)	30 days
Secondary	hospital mortality	death within 30 days of operation	30 days

External Links

•   Mansoura university