NCT04401722

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2018

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2020

Completed
24 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 25, 2020

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

May 21, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 26, 2020

Completed
Last Updated

June 9, 2020

Status Verified

June 1, 2020

Enrollment Period

2.1 years

First QC Date

May 21, 2020

Last Update Submit

June 6, 2020

Conditions

Periampullary Cancer

Keywords

pancreaticodudenctomyPOPFHIGH ALTITUDE

Outcome Measures

Primary Outcomes (1)

  • the overall postoperative complications

    the overall postoperative complications

    30 DAYS

Secondary Outcomes (3)

  • blood loss

    INTRAOPERATIVE

  • Pulmonary embolism (PE)

    30 days

  • hospital mortality

    30 days

Study Arms (2)

PD in normal altitude

ACTIVE COMPARATOR

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

Procedure: PANCREATICODUDENECTOMY

PD in high altitude region.

ACTIVE COMPARATOR

PD underwent in high altitude region.

Procedure: PANCREATICODUDENECTOMY

Interventions

PANCREATICODUDENECTOMYPROCEDURE

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

Also known as: Whippl,s operation
PD in high altitude region.PD in normal altitude

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • periampulary tumour

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mahmoud Abd El Wahab

Al Mansurah, 356111, Egypt

Location

Related 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.

    PMID: 29961462BACKGROUND

  • 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.

    PMID: 31461084RESULT

  • 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.

    PMID: 30413347RESULT

  • 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.

    PMID: 31765479RESULT

Related Links

MeSH Terms

Conditions

Altitude Sickness

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract Diseases

Study Officials

  • Ayman E Nakeeb, MD

    Mansoura University, Gastrointestinal Surgery Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
OUTCOME ASESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
gastrointestinal surgical center, Mansoura University

Study Record Dates

First Submitted

May 21, 2020

First Posted

May 26, 2020

Study Start

March 1, 2018

Primary Completion

April 1, 2020

Study Completion

April 25, 2020

Last Updated

June 9, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will share

it will be available for other researchers

Shared Documents
STUDY PROTOCOL
Time Frame
6 month
Access Criteria
elnakeebayman@yahoo.com
More information

Available IPD Datasets

Study Protocol (Ayman El Nakeeb)Access

Locations

EG(1)