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Robotic versus open pancreatoduodenectomy for pancreatic or periampullary tumours: a multicentre, randomised controlled trial

Robotic versus open pancreatoduodenectomy for pancreatic or periampullary tumours: a multicentre, randomised controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200056809
Enrollment
Unknown
Registered
2022-02-18
Start date
2022-03-01
Completion date
Unknown
Last updated
2023-09-11

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

Conditions

Pancreatic head and periampullary malignant and benign diseases

Interventions

Group A:Robotic pancreatoduodenectomy
Group B:Open pancreatoduodenectomy

Sponsors

The First Medical Center of the People's Liberation Army General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Obtain informed consent signed by the patient or his legal representative; 2. Compliance with the study protocol and follow-up process; 3. Patients aged 18-75 years, no gender limit; 4. No surgical contraindations, tolerance to radical surgery, ECOG behavioral status score 0-1, life expectancy >= 12 weeks, ASA score <=3; 5. According to preoperative clinical symptoms, imaging examination, tumor markers and other auxiliary examinations, and postoperative pathology, pancreatic head and periampullary tumor was diagnosed, and pancreaticoduodenectomy was required.

Exclusion criteria

Exclusion criteria: 1. Malignant tumors in other areas in the last 5 years; Patients with brain, lung, bone or abdominal lymph node metastases; 2. Complicated with severe cardiopulmonary insufficiency, liver and kidney insufficiency; 3. HCV, HIV and syphilis infection; 4. Pregnant or lactating patients.

Design outcomes

Primary

MeasureTime frame
postoperative hospital stay;

Secondary

MeasureTime frame
blood loss;operative time;pancreatic fistula rate;postoperative morbidity rate;reoperation rate;90-day mortality;

Countries

China

Contacts

Public ContactLiu Rong

The First Medical Center of the People's Liberation Army General Hospital

liurong301@126.com+86 10 66937591

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 9, 2026