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Recruiting NA INTERVENTIONAL 2-arm NCT05660915

A Prospective Clinical Study Using an Artery-first Intermediate Approach in Robot-assisted Pancreaticoduodenectomy

A Prospective Clinical Study of the Safety and Efficacy of Robot-assisted Pancreaticoduodenectomy Using an Artery-first Intermediate Approach

Sponsor: The First Affiliated Hospital of University of South China

Updated 5 times since 2023 Last updated: Feb 23, 2023 Started: Jun 1, 2023 Primary completion: Apr 1, 2026 Completion: Apr 1, 2026
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT05660915, this NA trial focuses on Common Bile Duct Diseases and Pancreatic Cancer and remains actively recruiting participants. Sponsored by The First Affiliated Hospital of University of South China, it has been updated 5 times since 2023, reflecting limited change activity. This study contributes to the evolving evidence base for cancer treatment protocols.

Study Description(click to expand)

Firstly, according to the inclusion and exclusion criteria, all patients from the First Affiliated Hospital of the University of South China who were to undergo robot-assisted pancreaticoduodenectomy were randomized into two groups, namely the standard approach group and the intermediate approach group. The two groups were under the management of the same surgical team throughout the perioperative period, and were managed according to standardized Enhanced recovery after surgery approach. The brief procedure includes: (1) Placement of the trocar in appropriate place; (2) An ultrasonic knife was used to cut the appetizing colonic ligament and expose the pancreas. The superior mesenteric vein, common hepatic artery, proper hepatic artery and gastroduodenal artery were exposed, and the adjacent lymph nodes were dissected. The right gastric artery and gastroduodenal artery were resected to expose the portal vein. Dissect the common bile duct and peel the gallbladder from the bile fossa; The free common bile duct was dissected and suspended with a vascular sling. (3) Resection of distal stomach and jejunum. The pancreas was cut off with ultrasonic knife. (4) Child reconstruction - pancreaticojejunostomy (pancreatic duct to jejunal mucosa anastomosis) , cholangiojejunostomy and gastrojejunostomy were adopted. (5) Thoroughly rinse the abdominal cavity and place the...

Firstly, according to the inclusion and exclusion criteria, all patients from the First Affiliated Hospital of the University of South China who were to undergo robot-assisted pancreaticoduodenectomy were randomized into two groups, namely the standard approach group and the intermediate approach group. The two groups were under the management of the same surgical team throughout the perioperative period, and were managed according to standardized Enhanced recovery after surgery approach. The brief procedure includes: (1) Placement of the trocar in appropriate place; (2) An ultrasonic knife was used to cut the appetizing colonic ligament and expose the pancreas. The superior mesenteric vein, common hepatic artery, proper hepatic artery and gastroduodenal artery were exposed, and the adjacent lymph nodes were dissected. The right gastric artery and gastroduodenal artery were resected to expose the portal vein. Dissect the common bile duct and peel the gallbladder from the bile fossa; The free common bile duct was dissected and suspended with a vascular sling. (3) Resection of distal stomach and jejunum. The pancreas was cut off with ultrasonic knife. (4) Child reconstruction - pancreaticojejunostomy (pancreatic duct to jejunal mucosa anastomosis) , cholangiojejunostomy and gastrojejunostomy were adopted. (5) Thoroughly rinse the abdominal cavity and place the abdominal drainage tube properly after checking for no active bleeding.The key point of surgery in the standard approach group was to first reveal portal vein-superior mesenteric vein and gradually complete the resection of the uncinate process of pancreas based on the reference of portal vein-superior mesenteric vein. In the intermediate approach group, the area between superior mesenteric vein and superior mesenteric artery was defined as the intermediate area and dissection was performed in this area to achieve the removal of the uncinate process of pancreas. Subsequently, data related to intraoperative conditions (such as operation time, amount of blood loss, etc.) and postoperative complications were collected and statistically analyzed to verify the safety of the intermediate approach, and short-term prognostic data was collected to verify its effectiveness.

Status Flow

~Jan 2023 – ~Feb 2023 · 31 days · monthly snapshotNot Yet Recruiting~Feb 2023 – ~Mar 2023 · 28 days · monthly snapshotNot Yet Recruiting~Mar 2023 – ~Jul 2024 · 16 months · monthly snapshotRecruiting~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotRecruiting~Sep 2024 – present · 19 months · monthly snapshotRecruiting

Change History

5 versions recorded
  1. Sep 2024 — Present [monthly]

    Recruiting NA

  2. Jul 2024 — Sep 2024 [monthly]

    Recruiting NA

  3. Mar 2023 — Jul 2024 [monthly]

    Recruiting NA

    Status: Not Yet RecruitingRecruiting

  4. Feb 2023 — Mar 2023 [monthly]

    Not Yet Recruiting NA

  5. Jan 2023 — Feb 2023 [monthly]

    Not Yet Recruiting NA

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • The First Affiliated Hospital of University of South China
Data source: The First Affiliated Hospital of University of South China

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations