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2022-09-01
2023-12-30
2023-12-30
48
NCT06661135
Cairo University
Cairo University
INTERVENTIONAL
Open Versus Total Laparoscopic Pancreaticoduodenectomy
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 .
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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2024-10-18 | N/A | 2024-10-24 |
2024-10-24 | N/A | 2024-10-28 |
2024-10-28 | N/A | 2024-10 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Randomized
Interventional Model:
Parallel
Masking:
Double
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 reconstructio | PROCEDURE: TLPD total laparoscopic pancreaticoduodenectomy
|
| 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
|
| Primary Outcome Measures | 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 | 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 |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
20 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
