A comparison of robot-assisted laparoscopic pancreaticoduodenectomy and open pancreaticoduodenectomy: a Prospective, Non-randomized Controlled Study

A comparison of Robot-assisted Laparoscopic Pancreaticoduodenectomy and Open Pancreaticoduodenectomy in patients with benign, borderline and malignant pathologies of the pancreatic head, distal common bile duct and periampullary region: A Prospective, matched Controlled Study in China

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12614000299606

Enrollment

326

Registered

2014-03-20

Start date

2010-01-01

Completion date

2013-12-31

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Robot-assisted laparoscopic pancreaticoduodenectomy (RLPD) is a novel minimally invasive surgery technique. None of prospective studies of large sample size comparing RLPD and OPD have been presented and long-tern oncologic outcome is lacking.This study aimed to prospectively evaluate the effectiveness and advancement of RLPD versus open PD (OPD).

Interventions

Robotic-assisted pancreaticoduodenectomy Robot-assisted laparoscopy is the most advanced minimally invasive surgery technique characteristic of a magnified three-dimensional visualization and endowrist instruments with greater range of motion.Pancreaticoduodenectomy (PD) is a major surgical operation involving the pancreas, duodenum, and pylorus in most cases. Approximate duration required to complete robotic-assisted pancreaticoduodenectomy is about 410minutes.

Study design

Allocation

Non-randomised trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to 77 Years

Healthy volunteers

Inclusion criteria

Being at least 18 years old; a resectable malignant or borderline malignant pathology of the pancreatic head (including stage I and II pancreatic cancer), distal common bile duct, or periampullary region in accordance with the National Comprehensive Cancer Network (NCCN) Guidelines; and having received no neoadjuvant chemoradiation therapy.

Exclusion criteria

Having an excessively large lesion (tumor size >10 cm) invading adjacent organs and major vessels; involvement of superior mesenteric vein or portal vein (PV) longer than 3 cm possibly requiring interposed graft reconstruction, for which OPD was determined to be more suitable than RLDP; scheduled for surgical treatment other than PD, such as palliative biliary and gastroenteric anastomoses; presence of complicating serious cardiopulmonary or hepatorenal insufficiency; extensive intraperitoneal or extraperitoneal metastases; and refusal to participate in or withdrawing from this study.

Outcome results