Open Versus Total Laparoscopic Pancreaticoduodenectomy

Not Applicable

Completed

• Conditions: Pancreatic Neoplasms; Laparoscopic Pancreaticoduodenectomy; Whipple Operation

• Registration Number: NCT06661135
• Lead Sponsor: Cairo University

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 .

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 Timeline

• Study Start: 2022-09-01
• Primary Completion: 2023-12-30
• Study Completion: 2023-12-30
• Status Verified: 2024-10
• Study First Submitted: 2024-10-18
• Study First Submitted QC: 2024-10-24
• Last Update Submitted: 2024-10-24
• Study First Posted: 2024-10-28
• Last Update Posted: 2024-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Length of hospital stay	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 .	Time spent in hospital in days after surgery
Length of postoperative surgical ICU stay	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 .	Length of postoperative surgical ICU stay In days
Amount of blood loss	From start of surgery till skin closure	Amount of blood lost intraoperative assessed in milliliters
Amount of intraoperative blood transfusion	From start of surgery of every participant till skin closure	Amount of intraoperative PRBC units transfused intraoperative
30-day mortality	From the date of surgery till one month after	Reporting Death if happens in the first month postoperatively
Operative time in minutes	From time of skin incision till time of skin closure	Time spent in surgery

Secondary Outcome Measures

Name	Time	Method
Severity of Postoperative pain	From awakening after surgery ( day 0 ) till ( day 7 ) afterwards	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
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	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
Lymph node yield after surgery	It takes 5 days after surgery for the pathological assessment to be completed	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	Ratio of positive lymph nodes to total number of lymph nodes harvested
State of resection margins after pathological assessment	It takes 5 days after surgery for the pathological assessment to be completed	State of specimen margins ( free or infiltrated by Tumor )

Trial Locations

Locations (1)

Kasralainy school of medicine , Cairo university; 🇪🇬 Cairo, Egypt