Clinical trial NCT06661135: Open Versus Total Laparoscopic Pancreaticoduodenectomy
Official title: Total Laparoscopic Versus Open Pancreaticoduodenectomy: a Prospective Comparative Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pancreatic Neoplasms
Laparoscopic Pancreaticoduodenectomy
Whipple Operation
Keywords: Total laparoscopic pancreaticoduodenectomy
Open vs laparoscopic pancreaticoduodenectomy
Pancreatic neoplasm surgery in developing countries
Lead sponsor: Cairo University
Sponsor class: OTHER
Collaborators: name: Department of general surgery Cairo University
First posted: 2024-10-28
Enrollment: 48
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Length of hospital stay
timeFrame: 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 .
measure: Length of postoperative surgical ICU stay
timeFrame: 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 .
measure: Amount of blood loss
timeFrame: From start of surgery till skin closure
measure: Amount of intraoperative blood transfusion
timeFrame: From start of surgery of every participant till skin closure
measure: 30-day mortality
timeFrame: From the date of surgery till one month after
measure: Operative time in minutes
timeFrame: From time of skin incision till time of skin closure
Secondary outcomes:
measure: Severity of Postoperative pain
timeFrame: From awakening after surgery ( day 0 ) till ( day 7 ) afterwards
measure: Gastrointestinal recovery ( time to tolerate oral intake)
timeFrame: 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
measure: Lymph node yield after surgery
timeFrame: It takes 5 days after surgery for the pathological assessment to be completed
measure: Ratio of positive lymph nodes to total number of lymph nodes harvested
timeFrame: It takes 5 days after surgery for the pathological assessment to be completed
measure: State of resection margins after pathological assessment
timeFrame: It takes 5 days after surgery for the pathological assessment to be completed
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasralainy school of medicine , Cairo university
Study officials:
References: