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Robot surgeons take on pancreatic cancer in major trial

NCT ID NCT04400357

Disease control Sponsor: Ruijin Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study compared robotic-assisted pancreatic surgery to the standard open approach for people with pancreatic and related tumors. Researchers wanted to see if robotic surgery could help patients recover faster after the operation. A total of 268 patients took part across multiple hospitals, and the main focus was on how quickly they regained normal function like eating, walking, and pain control.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Robotic-assisted pancreaticoduodenectomy (surgical procedure)
What this could lead to
If robotic surgery proves as safe and effective as open surgery, it could offer patients a less invasive option with faster recovery after pancreatic tumor removal.
What could go wrong
This is a completed phase 3 trial, but non-inferiority means it only aims to show robotic surgery is not worse than open surgery, not that it is better. Results may not apply to all patients or settings.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

268 people

The number who actually took part.

Started

Sep 2020

Finished

Feb 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patients with an indication for elective pancreaticoduodenectomy for malignant, premalignant, and symptomatic benign disease in the pancreatic and periampullary region * Performance status of 0/1 (assessed based on comorbidities using the Karnofsky score and Malnutrition Universal Screening Tool score among others, especially for patients with malignant disease) * Imaging with computed tomography and/or MRI pancreas performed within 8 weeks for benign and 4 weeks for malignant disease; for the latter tumor staging with MRI liver, CT chest, and Cancer Antigen 19-9 is also mandatory. Exclusion Criteria: * Body mass index \> 35 kg/m2 * Pregnancy * Previous history of major abdominal surgery * Requirement for multivisceral resection (additional surgical resection) * Preoperative chemotherapy and/or radiotherapy (for patients with pancreatic adenocarcinoma) * Involvement of major regional vessels by the tumor (portal and superior mesenteric vein, superior mesenteric artery, hepatic artery, celiac artery) as defined by the borderline resectable and locally advanced nomenclature

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Conditions

The condition(s) this trial relates to.

ampulla of vater adenocarcinoma cholangiocarcinoma chronic pancreatitis duodenal adenocarcinoma extrahepatic bile duct carcinoma pancreatic adenocarcinoma Pancreatic Cyst pancreatic neoplasm pancreatic neuroendocrine tumor Recurrence

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Ampullary adenocarcinoma Cholangiocarcinoma, extrahepatic Chronic pancreatitis Duodenal adenocarcinoma Pancreatic adenocarcinoma Pancreatic cysts Pancreatic endocrine tumors

Contacts and locations

Locations

  • Ruijin Hospital Shanghai Jiaotong University School of Medicine

    Shanghai, Shanghai Municipality, 200025, China

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