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Robotic vs open: which whipple surgery is safer for pancreatic cancer?

NCT ID NCT04763642

Disease control Sponsor: State Budget Public Health Institution Scientific Research Institute - Ochapovsky Regional Clinical 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study compared miniinvasive (robotic or laparoscopic) Whipple surgery to the traditional open approach in 320 patients with pancreatic, bile duct, or ampulla of Vater cancers. The goal was to see which method leads to fewer complications like pancreatic leaks, bleeding, or infections. Results could help guide surgical choices for these cancers.

What this could mean

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

Active substance
Whipple surgery (robotic, laparoscopic, or open)
What this could lead to
If successful, this could show that less invasive surgery is as safe and effective as open surgery, with possibly shorter hospital stays and fewer complications.
What could go wrong
This is a completed study comparing surgical techniques, not a new drug or cure. Results may not apply to all patients or hospitals, and surgery always carries risks like infection or bleeding.

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

320 people

The number who actually took part.

Started

Jan 2020

Finished

Apr 2024

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

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

Ages

21 to 80 years

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: * Age: 21-75 years * Clinically/histologically established diagnosis of the cancer; * Preoperative imaging assessment is resectable or borderline resectable Exclusion Criteria: * Benign tumors of the head of pancreas; * Distant metastasis; * Conversion to laparotomy; * Instrumental findings of the tumor process prevalence; * General somatic status on the ASA III-V scale; * Acute pancreatitis; * Hyperbilirubinemia above 60 μmol/L (3.51 mg/dl) ((normal range, 4-20 μmol/L)). * Patients with intraoperative positive express-histological presence of tumor growth along the border of the pancreas resection

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Conditions

The condition(s) this trial relates to.

ampulla of vater cancer bile duct cancer bile duct neoplasm malignant pancreatic neoplasm pancreatic neoplasm

As listed by the trial registrant

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

Ampulla of vater cancer Bile duct cancer Pancreatic cancer

Contacts and locations

Locations

  • Ochapovsky Regional Clinical Hospital № 1

    Krasnodar, Krasnodarskiy Kray, 350068, Russia

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