NCT05463328

Brief Summary

Compare open and laparoscopic assisted pancreaticoduodenectomy regarding intraoprative blood loss, organ injury, completion of planned laparoscopic steps, duration and early post operative course of pain, hem stability, oral feeding, leakage(pancreatic, billary and intestinal). ,bleeding, mortality, lymph nodes and safety margins .

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 not_applicable

Timeline
Completed

Started Dec 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

April 8, 2022

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 19, 2022

Completed
5 months until next milestone

Study Start

First participant enrolled

December 1, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

July 19, 2022

Status Verified

July 1, 2022

Enrollment Period

1 year

First QC Date

April 8, 2022

Last Update Submit

July 18, 2022

Conditions

Pancreas Neoplasm

Outcome Measures

Primary Outcomes (3)

  • post operative pain.

    Compare the post operative pain betweenopen and laparoscopic assisted pancreaticoduodenectomy

    Compare the post operative pain between open and laparoscopic assisted pancreaticoduodenctomy in the first week after operation

  • Blood loss

    Compare between the intra operative blood loss in the open and laparoscopic assisted pancreaticoduodenectomy

    Compare the intra operative blood loss between open and laparoscopic assisted pancreaticoduodenectomy during the operation

  • Rate of postoperative anastomosis leakage(pancreatic,billary and intestinal).

    Compare the rate of postoperative anastomosis leakage(pancreatic,billary and intestinal) between the open and laparoscopic assisted pancreaticoduodenctomy

    Rate of postoperative anastomosis leakage(pancreatic,billary and intestinal) in the first month after operation

Secondary Outcomes (4)

  • Postoperative haemorrhage

    In the first 2 weeks

  • Postoperative wound infection.

    In the first 2 weeks

  • Starting oral feeding

    In the first 3 days after operation

  • Postoperative 30 days mortality rate.

    In the first 30days after operation

Study Arms (2)

Laparoscopic assisted pancreaticoduodenctomy

EXPERIMENTAL

If inclusion criteria are met ,these group of patients will undergo Laparoscopic assisted pancreaticoduodenctomy.

Procedure: laparoscopic assisted pancreaticoduodenectomy

Open pancreaticduodenctomy

ACTIVE COMPARATOR

criteria are met ,these group of patients will undergo open pancreaticoduodenctomy

Procedure: Open pancreaticduodenctomy

Interventions

laparoscopic assisted pancreaticoduodenectomyPROCEDURE

laparoscopic assisted pancreaticoduodenectomy.

Laparoscopic assisted pancreaticoduodenctomy
Open pancreaticduodenctomyPROCEDURE

Open pancreaticduodenctomy

Open pancreaticduodenctomy

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age less than 70 years.
  • resectable tumour,
  • fit for surgery

You may not qualify if:

  • patients with jaundice with serum bilirubin above 200mml/dl.
  • patients with bleeding tendency until corrected.
  • patients with advanced and metastatic malignancy.
  • patients with cardiopulmonary diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Newhook TE, LaPar DJ, Lindberg JM, Bauer TW, Adams RB, Zaydfudim VM. Morbidity and mortality of pancreaticoduodenectomy for benign and premalignant pancreatic neoplasms. J Gastrointest Surg. 2015 Jun;19(6):1072-7. doi: 10.1007/s11605-015-2799-y. Epub 2015 Mar 24.

    PMID: 25801594BACKGROUND

  • Erratum to "Cancer statistics, 2021". CA Cancer J Clin. 2021 Jul;71(4):359. doi: 10.3322/caac.21669. Epub 2021 Apr 19. No abstract available.

    PMID: 34232515BACKGROUND

  • Correction to Lancet Gastroenterol Hepatol 2019; 4: 934-47. Lancet Gastroenterol Hepatol. 2020 Mar;5(3):e2. doi: 10.1016/S2468-1253(20)30018-2. No abstract available.

    PMID: 32061329BACKGROUND

  • Bausch D, Keck T. Minimally Invasive Surgery of Pancreatic Cancer: Feasibility and Rationale. Visc Med. 2018 Dec;34(6):440-443. doi: 10.1159/000495324. Epub 2018 Nov 28.

    PMID: 30675490BACKGROUND

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Central Study Contacts

mohammed aly ahmed, Assist.lecturer

CONTACT

01067575588mohamed1234ali1991@gmail.com

Mostafa Mahmoud Mohammed Sayed, Assist.prof

CONTACT

+201271207839mostafa.sayed@aun.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant lectuerer

Study Record Dates

First Submitted

April 8, 2022

First Posted

July 19, 2022

Study Start

December 1, 2022

Primary Completion

December 1, 2023

Study Completion

December 1, 2023

Last Updated

July 19, 2022

Record last verified: 2022-07