Clinical Impact of Altitude Level on Surgical Outcomes of Pancreaticoduodenectomy (PD)

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.

Study Overview

• Status: Completed
• Conditions: Periampullary Cancer
• Intervention / Treatment: Procedure: PANCREATICODUDENECTOMY

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 Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Mansoura, Egypt, 356111
    • Mahmoud Abd El Wahab

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• periampulary tumour

Exclusion Criteria:

• liver cirrhosis,
• PG,
• advanced tumour,
• vascular resection

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: PD in normal altitude; PD underwent in the area at the level of the sea, normal altitude region	Procedure: PANCREATICODUDENECTOMY; dissection and removal of periampulary tumour with 3 reconstruction PJ, HJ, and GJ; Other Names: Whippl,s operation
Active Comparator: PD in high altitude region.; PD underwent in high altitude region.	Procedure: PANCREATICODUDENECTOMY; dissection and removal of periampulary tumour with 3 reconstruction PJ, HJ, and GJ; Other Names: Whippl,s operation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the overall postoperative complications	the overall postoperative complications	30 DAYS

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
blood loss	blood loss	INTRAOPERATIVE
Pulmonary embolism (PE)	Pulmonary embolism (PE)	30 days
hospital mortality	death within 30 days of operation	30 days

Collaborators and Investigators

• Sponsor: Mansoura University
• Investigators: Principal Investigator: Ayman E Nakeeb, MD, Mansoura University, Gastrointestinal Surgery Center

Publications and helpful links

General 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.
• 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.
• 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.
• 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.

Helpful Links

• Mansoura university

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2018
• Primary Completion (Actual): April 1, 2020
• Study Completion (Actual): April 25, 2020

Study Registration Dates

• First Submitted: May 21, 2020
• First Submitted That Met QC Criteria: May 22, 2020
• First Posted (Actual): May 26, 2020

Study Record Updates

• Last Update Posted (Actual): June 9, 2020
• Last Update Submitted That Met QC Criteria: June 6, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: POPF; pancreaticodudenctomy; HIGH ALTITUDE
• Other Study ID Numbers: PD in high altitude

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: it will be available for other researchers
• IPD Sharing Time Frame: 6 month
• IPD Sharing Access Criteria: elnakeebayman@yahoo.com
• IPD Sharing Supporting Information Type: Study Protocol

Study Data/Documents

1. Study Protocol
   Information identifier: Ayman El Nakeeb
   Information comments: through elnakeebayman@yahoo.com

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No