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OpenTrials
Completed

NCT Number: NCT06661135

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 .

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Key information

Conditions

Pancreatic Neoplasms Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Laparoscopic Pancreaticoduodenectomy Neoplasms Neoplasms by Site Pancreatic Diseases Whipple Operation

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kasralainy school of medicine , Cairo university

Cairo, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

TLPD total laparoscopic pancreaticoduodenectomy

Procedure

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

OPD open pancreaticoduodenectomy

Procedure

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

Primary outcomes

  1. Length of hospital stay

    Time frame: 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

  2. Length of postoperative surgical ICU stay

    Time frame: 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

  3. Amount of blood loss

    Time frame: From start of surgery till skin closure

    Amount of blood lost intraoperative assessed in milliliters

  4. Amount of intraoperative blood transfusion

    Time frame: From start of surgery of every participant till skin closure

    Amount of intraoperative PRBC units transfused intraoperative

  5. 30-day mortality

    Time frame: From the date of surgery till one month after

    Reporting Death if happens in the first month postoperatively

  6. Operative time in minutes

    Time frame: From time of skin incision till time of skin closure

    Time spent in surgery

Secondary outcomes

  1. Severity of Postoperative pain

    Time frame: 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

  2. Gastrointestinal recovery ( time to tolerate oral intake)

    Time frame: 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

  3. Lymph node yield after surgery

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

    Number of lymph nodes harvested

  4. Ratio of positive lymph nodes to total number of lymph nodes harvested

    Time frame: 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

  5. State of resection margins after pathological assessment

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

    State of specimen margins ( free or infiltrated by Tumor )

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Collaborators

  • Department of general surgery Cairo University

Registry information

Official study title

Total Laparoscopic Versus Open Pancreaticoduodenectomy: a Prospective Comparative Clinical Study

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 28, 2024
Registry last updated
Oct 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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