Pancreatic CancerNCT04763642
The Comparison of Miniinvasive and Open Pancreaticoduodenectomy for Cancer Pancreaticobiliary Zone
A study testing pancreaticoduodenectomy in people with Pancreatic Cancer and Bile Duct Cancer, run by State Budget Public Health Institution Scientific Research Institute - Ochapovsky Regional Clinical Hospital at 1 site in Russia.
Trial summary
The Comparison of Miniinvasive and Open Pancreaticoduodenectomy for Cancer Pancreaticobiliary Zone Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Pancreatic Cancer, Bile Duct Cancer, Ampulla of Vater Cancer
- What is being tested?
- pancreaticoduodenectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 320 participants
- Where
- 1 siteRussia
- Study dates
- 1 Jan 2020to 30 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 21-75 years
- Clinically/histologically established diagnosis of the cancer;
- Preoperative imaging assessment is resectable or borderline resectable
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Russia1 site
Ochapovsky Regional Clinical Hospital № 1
Krasnodar, Krasnodarskiy Kray, 350068
About this study
The Comparison of Miniinvasive and Open Pancreaticoduodenectomy for Cancer Pancreaticobiliary Zone
Read the detailed description
Minimally invasive surgery is undoubtedly the method of choice for multiple gastrointestinal surgical procedures because of its minimally invasive nature and number of benefits such as reducing postoperative pain, shorter hospital stays, and earlier return to work. Current advances in technological innovation and surgical strategies have made surgical procedures on the pancreas a routine practice. However, the use of new surgical techniques in pancreatic surgery has been slow due to the complexity of the operations and the steep learning curve required for their use. For example, minimally invasive pancreatoduodenectomies (MIPD) have not yet become widespread. Due to these interventions have a complex reconstructive stage MIPD are still performed in a very few centers by specialized surgeons.
Although laparoscopic PD was first described in 1994 and the robotic approach in 2003, MIPD still account for less than 14% of all DPE cases. The multicenter randomized controlled trial (LEOPARD-2) for the first time compared laparoscopic and open pancreatoduodenectomy for pancreatic or periampullary tumors. The study that involved 99 patients did not reveal the superiority of laparoscopic PD (LPD) and provided an estimated mortality of 6%; 5 patients died in the laparoscopy group and 1 patient died in the group open PD. The trial was stopped early due to high mortality in the migratory invasive interventions group. Therefore, advantages of minimally invasive procedures for removal of pancreato-biliary zone tumors remain controversial.
In our study, we analyzed perioperative surgical outcomes and short-term survival outcomes in patients undergoing MIPD, including LPD and robotic PD (RPD), as well as "open" proximal pancreatoduodenectomy (OPD).
- Conditions
- Pancreatic Cancer, Bile Duct Cancer, Ampulla of Vater Cancer
- Being tested
- pancreaticoduodenectomy
- Keywords
- pancreatoduodenectomy, miniinvasive, complication, Morbidity, Mortality
- Medical subject headings
- Pancreatic Neoplasms, Bile Duct Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pancreaticoduodenectomyProcedure or surgery
Robotic Whipple operation Open Whipple operation Laparoscopic Whipple operation
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic Pancreaticoduodenectomy (LPD) | Active comparator | Not described Receives: Procedure: pancreaticoduodenectomy |
| Robotic Pancreaticoduodenectomy (RPD) | Active comparator | Not described Receives: Procedure: pancreaticoduodenectomy |
| Open Pancreaticoduodenectomy (OPD) | Placebo comparator | Not described Receives: Procedure: pancreaticoduodenectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall complications
The proportion of all complications after operation accounted for the total number of patients
Measured: up to 30 days
Pancreatic fistula
The international study group (ISGPF) definition: A drain output of any measurable volume of fluid on or after postoperative day 3 with an amylase content greater than 3 times the serum amylase activity. Three different grades of postoperative fistula (grades A, B, C) are defined according to the clinical impact on the patient's hospital course.
Measured: up to 30 days
Intra-abdominal bleeding
he International Study Group of Pancreatic Surgery (ISGPS) definition: Blood loss through abdominal drains or nasogastric tube;hematemesis or melena; clinical deterioration of the patient; unexplained hypotension or tachycardia; or laboratory findings such as a decreasing hemoglobin concentration.
Measured: up to 30 days
Intra-abdominal infection
Positive cultures of collection of fluid or blood,or persistent fever necessitating treatment with antibiotics and positive detection in image test.
Measured: up to 30 days
Secondary outcomes (1)
Length of hospital stay (day)
Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Measured: Up to postoperative 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start1 Jan 2020
- Primary completion19 Apr 2023
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 320 participants (actual)
Sponsor and investigators
- Lead sponsor
- State Budget Public Health Institution Scientific Research Institute - Ochapovsky Regional Clinical Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04763642
- Sponsor's protocol ID
- 20210202ORCH
- Status last verified
- Jan 2026
- First submitted
- 13 Feb 2021
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparison of Miniinvasive and Open Pancreaticoduodenectomy for Cancer Pancreaticobiliary Zone
- ClinicalTrials.gov ID
- NCT04763642
- Acronym / sponsor ID
- 20210202ORCH
- Conditions
- Pancreatic Cancer, Bile Duct Cancer, Ampulla of Vater Cancer
- Keywords
- pancreatoduodenectomy, miniinvasive, complication, Morbidity, Mortality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 320 participants (actual)
- Lead sponsor
- State Budget Public Health Institution Scientific Research Institute - Ochapovsky Regional Clinical HospitalOther government
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 19 Apr 2023 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 21 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Comparison of Miniinvasive and Open Pancreaticoduodenectomy for Cancer Pancreaticobiliary Zone
Detailed description
Minimally invasive surgery is undoubtedly the method of choice for multiple gastrointestinal surgical procedures because of its minimally invasive nature and number of benefits such as reducing postoperative pain, shorter hospital stays, and earlier return to work. Current advances in technological innovation and surgical strategies have made surgical procedures on the pancreas a routine practice. However, the use of new surgical techniques in pancreatic surgery has been slow due to the complexity of the operations and the steep learning curve required for their use. For example, minimally invasive pancreatoduodenectomies (MIPD) have not yet become widespread. Due to these interventions have a complex reconstructive stage MIPD are still performed in a very few centers by specialized surgeons.
Although laparoscopic PD was first described in 1994 and the robotic approach in 2003, MIPD still account for less than 14% of all DPE cases. The multicenter randomized controlled trial (LEOPARD-2) for the first time compared laparoscopic and open pancreatoduodenectomy for pancreatic or periampullary tumors. The study that involved 99 patients did not reveal the superiority of laparoscopic PD (LPD) and provided an estimated mortality of 6%; 5 patients died in the laparoscopy group and 1 patient died in the group open PD. The trial was stopped early due to high mortality in the migratory invasive interventions group. Therefore, advantages of minimally invasive procedures for removal of pancreato-biliary zone tumors remain controversial.
In our study, we analyzed perioperative surgical outcomes and short-term survival outcomes in patients undergoing MIPD, including LPD and robotic PD (RPD), as well as "open" proximal pancreatoduodenectomy (OPD).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic Pancreaticoduodenectomy (LPD) | Active comparator | Procedure: pancreaticoduodenectomy |
| Robotic Pancreaticoduodenectomy (RPD) | Active comparator | Procedure: pancreaticoduodenectomy |
| Open Pancreaticoduodenectomy (OPD) | Placebo comparator | Procedure: pancreaticoduodenectomy |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age: 21-75 years
- Clinically/histologically established diagnosis of the cancer;
- Preoperative imaging assessment is resectable or borderline resectable
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pancreaticoduodenectomyRobotic Whipple operation Open Whipple operation Laparoscopic Whipple operation | Procedure or surgery | Laparoscopic Pancreaticoduodenectomy (LPD), Open Pancreaticoduodenectomy (OPD), Robotic Pancreaticoduodenectomy (RPD) |
Primary outcome
Overall complications
Time frame: up to 30 days
The proportion of all complications after operation accounted for the total number of patients
Pancreatic fistula
Time frame: up to 30 days
The international study group (ISGPF) definition: A drain output of any measurable volume of fluid on or after postoperative day 3 with an amylase content greater than 3 times the serum amylase activity. Three different grades of postoperative fistula (grades A, B, C) are defined according to the clinical impact on the patient's hospital course.
Intra-abdominal bleeding
Time frame: up to 30 days
he International Study Group of Pancreatic Surgery (ISGPS) definition: Blood loss through abdominal drains or nasogastric tube;hematemesis or melena; clinical deterioration of the patient; unexplained hypotension or tachycardia; or laboratory findings such as a decreasing hemoglobin concentration.
Intra-abdominal infection
Time frame: up to 30 days
Positive cultures of collection of fluid or blood,or persistent fever necessitating treatment with antibiotics and positive detection in image test.
1 secondary outcome
Length of hospital stay (day)
Time frame: Up to postoperative 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pancreaticoduodenectomy in people with Pancreatic Cancer and Bile Duct Cancer, run by State Budget Public Health Institution Scientific Research Institute - Ochapovsky Regional Clinical Hospital at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall complications (time frame: up to 30 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.