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NCT06661135Completed

Open Versus Total Laparoscopic Pancreaticoduodenectomy

Total Laparoscopic Versus Open Pancreaticoduodenectomy: a Prospective Comparative Clinical Study

Source: ClinicalTrials.gov · Last updated 28 Oct 2024

Brief summary (registry, in English)

The goal of this clinical trial is to learn more about Total Laparoscopic pancreaticoduodenectomy ( TLPD ) which is performed for participants with pancreatic tumors using the laparoscope. TLPD is an operation that includes excision of the tumor with adjacent parts of the head of the pancreas, the duodenum and the part of the external biliary system . In the final step during surgery, and to reconnect the bowel after excision of the tumor, multiple anastomoses or connections will be made by the surgeon. To get valid results , the investigators performed this randomized controlled trial that compare TLPD with the traditional technique used to remove these tumors through open pancreaticoduodenectomy ( OPD ). The main questions this study aims to answer are: Is TLPD superior to open pancraticoduodenectomy ( OPD ) regarding the adequacy of surgical tumor excision ? Is TLPD lower than OPD regarding the early complications after surgery ? Researchers will compare participants receiving TLPD with participants receiving OPD regarding : The time of the operation. The amount of blood lost during surgery. Complications that may happen during or after surgery. Time of recovery after surgery. Duration to amputation. Duration of hospital stay. The adequacy of resection .

Status (registry)
Completed
Study type
Interventional
Enrollment
48 (actual)
First submitted
18 Oct 2024
Start date
1 Sept 2022
Primary completion date
30 Dec 2023
Lead sponsor
Cairo University
NCT number
NCT06661135

What you commit to

  • Study type: Interventional
  • Participants enrolled: 48
  • From 1 Sept 2022 to the primary completion date, 30 Dec 2023
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patients with history of previous laparotomies.

Other

  • Patients who were deemed inoperable or irresectable tumors by preoperative investigations.
  • Patients with complex ventral hernias.

Who the study is looking for

  • Patients presenting to the outpatient clinic of Kasr Alainy Hospitals with pancreatic head tumors, duodenal tumors, ampullary, or periampullary tumors who were candidates for either open or laparoscopic pancreaticoduodenectomy
  • Patients who accepted to participate in the study.

Age in the registry: 20 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Kasralainy school of medicine , Cairo university
Coordinator of this site? Confirm its status
CairoEgyptUnknown status

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.