Open Versus Total Laparoscopic Pancreaticoduodenectomy

NCT06661135 | Completed DMC

• 1 other identifier: Pancreaticoduodenectomy
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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 .

Conditions

Pancreatic Neoplasms; Laparoscopic Pancreaticoduodenectomy; Whipple Operation

Keywords

Total laparoscopic pancreaticoduodenectomy; Open vs laparoscopic pancreaticoduodenectomy; Pancreatic neoplasm surgery in developing countries

Outcome Measures

Primary Outcomes (6)

• Length of hospital stay

  Time spent in hospital in days after surgery

  From the date of surgery of every participant to the date of its discharge from hospital or death whichever comes first, assessed up to 3 months .

• Length of postoperative surgical ICU stay

  Length of postoperative surgical ICU stay In days

  From the date of admission to SICU ( surgical intensive care unit ) after surgery to the date of discharge to ward or death whichever comes first, assessed up to 3 months .

• Amount of blood loss

  Amount of blood lost intraoperative assessed in milliliters

  From start of surgery till skin closure

• Amount of intraoperative blood transfusion

  Amount of intraoperative PRBC units transfused intraoperative

  From start of surgery of every participant till skin closure

• 30-day mortality

  Reporting Death if happens in the first month postoperatively

  From the date of surgery till one month after

• Operative time in minutes

  Time spent in surgery

  From time of skin incision till time of skin closure

Secondary Outcomes (5)

• Severity of Postoperative pain

  From awakening after surgery ( day 0 ) till ( day 7 ) afterwards

• Gastrointestinal recovery ( time to tolerate oral intake)

  From Day two ( D2 ) after surgery for every participant till the date of tolerating oral fluids without vomiting for one complete day , up to two Weeks after surgery

• Lymph node yield after surgery

  It takes 5 days after surgery for the pathological assessment to be completed

• Ratio of positive lymph nodes to total number of lymph nodes harvested

  It takes 5 days after surgery for the pathological assessment to be completed

• State of resection margins after pathological assessment

  It takes 5 days after surgery for the pathological assessment to be completed

Study Arms (2)

TLPD

EXPERIMENTAL

This is the group that will receive laparoscopic pancreaicoduodenectomy trocars were inserted (between 5 and 6 trocars were required) and pneumoperitoneum induction was done. The surgeries were performed as previously described . Single loop reconstruction was adopted which involved the formation of all three anastomoses (pancreatico-jejeunostomy, hepatico-jejeunostomy, and gastro-jejeunostomy) on a single jejunal loop. The distance between the hepatico-jejeunostomy, and gastro-jejeunostomy was adjusted at 60 cm for all patients.

Procedure: TLPD total laparoscopic pancreaticoduodenectomy

OPD

ACTIVE COMPARATOR

this group will receive open PD In the OPD group, a bilateral abdominal subcost incision was performed for open surgery

Procedure: OPD open pancreaticoduodenectomy

Interventions

TLPD total laparoscopic pancreaticoduodenectomy PROCEDURE

It includes removal of the pancreatic or duodenal tumors using the laparoscopy

TLPD

OPD open pancreaticoduodenectomy PROCEDURE

It includes removal of the pancreatic or duodenal tumors using the open technique

OPD

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead
• Department of general surgery Cairo University: collaborator

Study Sites (1)

Kasralainy school of medicine , Cairo university

Cairo, Egypt

Location

Related Publications (1)

• Mostafa MS, Hamour D, Aiad GAN, Balamoun HA, Khattab MH, Shazly MN, Nageeb ME, Mohamed AAA. Laparoscopic versus open pancreatoduodenectomy: a pilot randomized trial in a developing African country. Surg Endosc. 2025 Dec 4. doi: 10.1007/s00464-025-12377-x. Online ahead of print.

  PMID: 41345531 DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The investigator and the outcomes assessor who asses the postoperative pain were not aware of which type of surgery the participant have had. Also the pathologist assessing the accuracy of oncology cal resection doesn't know the type of approach that participant had ( open or laparoscopic )
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: The included patients were equally randomized into two groups: the OPD group, which included patients that would undergo the traditional open procedure, and the LPD group, which included patients that would be subjected to the laparoscopic approach.

Study Record Dates

• First Submitted: October 18, 2024
• First Posted: October 28, 2024
• Study Start: September 1, 2022
• Primary Completion: December 30, 2023
• Study Completion: December 30, 2023
• Last Updated: October 28, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: For one year starting from the date of acceptance of the paper by a specific , high rank journal
• Access Criteria: Any researcher with ORCID number and valid institutional email address

Locations

EG (1)