NCT05171361

Brief Summary

To compare between the outcomes of pancreaticogastrostomy and pancreaticojejunostomy with dunking technique after Pancreaticodudenectomy in the treatment of operable periampullary malignancies.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2022

Status
unknown

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

First Submitted

Initial submission to the registry

December 10, 2021

Completed
18 days until next milestone

First Posted

Study publicly available on registry

December 28, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2023

Completed
Last Updated

December 28, 2021

Status Verified

December 1, 2021

Enrollment Period

1 year

First QC Date

December 10, 2021

Last Update Submit

December 27, 2021

Conditions

Keywords

pancreaticojejunostomypancreaticogastrostomy

Outcome Measures

Primary Outcomes (1)

  • Rate of postoperative anastomosis leakage

    Compare between dunking in pancreaticogastrostomy and pancreaticojejunostomy and the rate of postoperative anastomosis leakage

    One month

Study Arms (2)

Pancreaticojejunostomy

With Dunking Technique after Pancreaticodudenectomy

Procedure: Pancreaticogastrostomy versus Pancreaticojejunostomy with Dunking Technique

Pancreaticogastrostomy

With Dunking Technique after Pancreaticodudenectomy

Procedure: Pancreaticogastrostomy versus Pancreaticojejunostomy with Dunking Technique

Interventions

To compare between the outcomes of pancreaticogastrostomy and pancreaticojejunostomy with dunking technique after Pancreaticodudenectomy

PancreaticogastrostomyPancreaticojejunostomy

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All cases of resectable periampullary carcinomas

You may qualify if:

  • All cases of resectable periampullary carcinomas (cancer head of pancreas, ampullary carcinoma, distal cholangiocarcinoma and second part of duodenum adenocarcinoma) that are surgically fit according to ASA.

You may not qualify if:

  • \. Surgically unfit cases according to ASA 2. Locally advanced irresectable cases
  • Abutment or encasement of coeliac trunk
  • Encasement of SMA less than 180 degree of its axis
  • Encasement of portal/SMV more than 180 degree of its axis or infiltration segment too long more than 2.5 cm that the remaining segment will not coapts after resection.
  • \. Metastatic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Cheng Y, Briarava M, Lai M, Wang X, Tu B, Cheng N, Gong J, Yuan Y, Pilati P, Mocellin S. Pancreaticojejunostomy versus pancreaticogastrostomy reconstruction for the prevention of postoperative pancreatic fistula following pancreaticoduodenectomy. Cochrane Database Syst Rev. 2017 Sep 12;9(9):CD012257. doi: 10.1002/14651858.CD012257.pub2.

    PMID: 28898386BACKGROUND
  • Que W, Fang H, Yan B, Li J, Guo W, Zhai W, Zhang S. Pancreaticogastrostomy versus pancreaticojejunostomy after pancreaticoduodenectomy: a meta-analysis of randomized controlled trials. Am J Surg. 2015 Jun;209(6):1074-82. doi: 10.1016/j.amjsurg.2014.07.019. Epub 2015 Jan 22.

    PMID: 25743406BACKGROUND

Central Study Contacts

Sherif Alaa Abdelhafez, Resident

CONTACT

Mostafa Mahmoud, Ass. professor

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
resident doctor

Study Record Dates

First Submitted

December 10, 2021

First Posted

December 28, 2021

Study Start

March 1, 2022

Primary Completion

March 1, 2023

Study Completion

April 1, 2023

Last Updated

December 28, 2021

Record last verified: 2021-12