Open Versus Total Laparoscopic Pancreaticoduodenectomy

Total Laparoscopic Versus Open Pancreaticoduodenectomy: a Prospective Comparative Clinical Study

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 .

Study Overview

• Status: Completed
• Conditions: Pancreatic Neoplasms; Laparoscopic Pancreaticoduodenectomy; Whipple Operation
• Intervention / Treatment: Procedure: TLPD total laparoscopic pancreaticoduodenectomy; Procedure: OPD open pancreaticoduodenectomy

Detailed Description

Pancreaticoduodenectomy (PD) is a major, complex abdominal surgery that involves removing the pancreatic head together with the common bile duct (CBD) and duodenum. It is usually associated with complications that can severely affect patients' health and lead to mortality.

Pancreaticoduodenectomy is mainly indicated for patients with malignant masses in the head of pancreas and the periampullary region and can be the treatment solution for these patients, providing them with a cure or prolonging their survival. Pancreaticoduodenectomy can also be indicated for some pancreatic cystic neoplasms, particularly intraductal papillary mucinous neoplasms (IPMNs) that can turn malignant, neuroendocrine tumors, metastatic lesions to the pancreas, gastrointestinal stromal tumors, pancreatitis, and major pancreatic injury.

Pancreaticoduodenectomy was not generally accepted until the report introduced by Whipple in 1935 about his successful two-stage PD.. After about five years, Whipple conducted the first anatomic one-stage PD, including an antrectomy and a complete duodenectomy for a pancreatic head tumor.

Pancreaticoduodenectomy has been traditionally performed with an open approach. In 1994, Gagner and Pomp described laparoscopic PD (LPD). In their follow-up study, laparoscopic PD was concluded to have a high conversion rate with no advantages over open PD (OPD). Since then, laparoscopic approaches have been growingly reported, with ongoing research aiming to assess if LPD, being a minimally invasive approach, can improve postoperative morbidity. Nevertheless, LPD is still not broadly accepted. This study aimed to determine the advantages and disadvantages of performing total laparoscopic pancreaticoduodenectomy compared to the open approach.

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Kasralainy school of medicine , Cairo university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TLPD; 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; It includes removal of the pancreatic or duodenal tumors using the laparoscopy
Active Comparator: OPD; this group will receive open PD In the OPD group, a bilateral abdominal subcost incision was performed for open surgery	Procedure: OPD open pancreaticoduodenectomy; It includes removal of the pancreatic or duodenal tumors using the open technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severity of Postoperative pain	Assessing postoperative pain daily postoperative using visual analogue score that is a scale of grades from 0 to 10 , with 0 means no pain perceived and 10 indicates the worst pain possible perceived	From awakening after surgery ( day 0 ) till ( day 7 ) afterwards
Gastrointestinal recovery ( time to tolerate oral intake)	Time to tolerate oral fluid intake without vomiting . Usually the participants were instructed to take fluids on day 2 after surgery and continue if tolerating and no vomiting occurred for one complete day	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	Number of lymph nodes harvested	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	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	State of specimen margins ( free or infiltrated by Tumor )	It takes 5 days after surgery for the pathological assessment to be completed

Collaborators and Investigators

• Sponsor: Cairo University
• Collaborators: Department of general surgery Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Actual): December 30, 2023
• Study Completion (Actual): December 30, 2023

Study Registration Dates

• First Submitted: October 18, 2024
• First Submitted That Met QC Criteria: October 24, 2024
• First Posted (Actual): October 28, 2024

Study Record Updates

• Last Update Posted (Actual): October 28, 2024
• Last Update Submitted That Met QC Criteria: October 24, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Total laparoscopic pancreaticoduodenectomy; Open vs laparoscopic pancreaticoduodenectomy; Pancreatic neoplasm surgery in developing countries
• Additional Relevant MeSH Terms: Endocrine System Diseases; Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms
• Other Study ID Numbers: Pancreaticoduodenectomy

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All scientific individual participant data will be ready for sharing including ( age, sex, associated commorbidies, size of the tumor , time of surgery, type of surgery, hospital stay , SICU stay , resection margin results , units of blood transfusion ,….) abiding in the same time to our local research ethical committee rules
• IPD Sharing Time Frame: For one year starting from the date of acceptance of the paper by a specific , high rank journal
• IPD Sharing Access Criteria: Any researcher with ORCID number and valid institutional email address
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No