PancreaticoduodenectomyNCT04171440
Observation of Perioperative Outcomes of Robotic Pancreaticoduodenectomy
A study testing robotic pancreaticoduodenectomy in people with Pancreaticoduodenectomy, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 2 sites in United States.
Trial summary
This is a multi-site prospective, single arm, observational study examining the outcomes of robotic pancreaticoduodenectomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreaticoduodenectomy
- What is being tested?
- robotic pancreaticoduodenectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 2 sitesUnited States
- Study dates
- 18 Feb 2020to 1 Oct 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥18 years old
- Symptomatic benign, premalignant, or resectable malignant periampullary and pancreatic tumor requiring resection
- Fit to undergo elective pancreaticoduodenectomy after evaluation by the surgical and anesthesiology teams
- Able to consent to participate in the study
- Appropriate for robotic approach as determined by participating surgeons
Who cannot join
- Arterial (superior mesenteric artery, celiac axis, hepatic artery) or venous involvement (superior mesenteric vein, portal vein) which meets the definition of borderline or unresectable tumor
- Pregnancy
- BMI >40 kg/m2
- Patient requires an additional surgical resection during the index operation (such as hepatectomy or colectomy)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Johns Hopkins Hospital
Baltimore, Maryland, 21287
Atrium Health
Charlotte, North Carolina, 28204
About this study
Official title: Perioperative Outcomes of Robotic Approach for Pancreaticoduodenectomy: a Multi-center, Prospective, Single Arm, Observational Study
This is a multi-site prospective, single arm, observational study examining the outcomes of robotic pancreaticoduodenectomy.
Read the detailed description
This is a multi-site prospective, single arm, observational study examining the outcomes of robotic pancreaticoduodenectomy. Adult patients with symptomatic benign, premalignant, or resectable malignant pathologies recommended for resection after multidisciplinary review and have already chosen to have robotic surgery will be evaluated for enrolling into the study.
Relevant operative, postoperative, and pathologic outcomes will be collected prospectively. The well-established enhanced recovery after pancreaticoduodenectomy pathway currently used in our institution will be applied to all patients postoperatively.
- Conditions
- Pancreaticoduodenectomy
- Being tested
- robotic pancreaticoduodenectomy
- Keywords
- minimally invasive, robotic, surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
robotic pancreaticoduodenectomyProcedure or surgery
The robotic pancreaticoduodenectomy is performed through small incisions using robotic-assisted technology. Pancreaticoduodenectomy is the operation that is necessary to remove tumors of the head and neck of the pancreas, lower portion of the bile duct, and the ampulla of Vater.
| Study group | Role | What they receive |
|---|---|---|
| Minimally Invasive Pancreaticoduodenectomy | Experimental | Patients that undergo pancreaticoduodenectomy through small incisions with state-of-the-art robotic-assisted technology. Receives: Procedure: robotic pancreaticoduodenectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of hospital stay
Days from date of intervention to discharge
Measured: up to 90 days post intervention
Secondary outcomes (9)
Time to functional recovery
Days to functional recovery, which requires that all the following are met:
- Pain controlled on oral analgesics only (Yes/no, only the date when the result first changes from No to Yes will be recorded)
- Able to maintain ≥50% of required caloric intake
- No need for intravenous fluids for hydration
- Return to independent mobility or baseline mobility for those with previous mobility deficits
Measured: Day 1 post-intervention to functional recovery
Number of participants experiencing complications
Number of participants who experience Clavien-Dindo Grade III or higher complications
Measured: Day 90 post-intervention
Operative estimated blood loss
Blood loss during the surgery (unit: ml)
Measured: During the surgery
Number of participants experiencing pancreaticoduodenectomy-specific complications
Number of participants who experience complications including pancreatic fistula, delayed gastric emptying, postoperative bleeding, wound infection, bile leak, chyle leak, other gastrointestinal leakage, re-intervention (radiographic,surgical, endoscopic), 30-day mortality, 90-day mortality.
Measured: Day 90 post-intervention
Pathological outcomes as assessed by Pathological response to neoadjuvant therapy
Pathological response to neoadjuvant therapy(if there is any) reported by pathologist reviewing the resected surgical specimen. Pathological outcomes as defined by Protocol for Examination of Specimens from Patients with Carcinoma of the Pancreas (Pancreas Exocrine 4.0.0.1), where: complete response (score 0) is no viable cancer cells; marked response/minimal residual cancer (score 1) is presence of single cells or rare small groups of cancer cells; moderate response (score 2) is residual cancer with evident tumor regression, but more than single cells or rare groups of cancer cells; poor or no response (score 3) is extensive residual cancer with no evident tumor regression.
Measured: Day 90-post intervention
Survival Outcome
Recurrence free outcome is from surgery to recurrence.
Measured: Overall survival is from surgery to last time of follow-up or death, assessed up to 60 months-post intervention.
Quality of life (QoL) as measured by EQ-5D-3L
The EQ-5D-3L questionnaire essentially consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS).
The EQ-5D-3L descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems.This decision results into a 1-digit number that expresses the level selected for that dimension. Numbers range from 1-3, with a higher number reflected more problems.
The EQ VAS records the patient's self-rated health on a vertical visual analogue scale where the endpoints are labelled 'Best imaginable health state' and 'Worst imaginable health state', ranging from 0 to 100. A higher score reflects a worse health state.
Measured: EQ-5D-3L will be measured at 2 to 4 weeks and 3 to 6 months-post intervention.
Quality of life (QoL) as measured by QLQ-C30 (version 3)
QLQ-C30 questionnaire includes five functional scales, three symptom scales, a global health status / QoL scale, and six single items. All of the scales and single-item measures range in score from 0 to 100. A higher score represents a higher response level.
Measured: QLQ-C30 will be measured at 2 to 4 weeks and 3 to 6 months-post intervention.
Exploratory outcomes
Comprehensive complication index (CCI) is calculated using the multiple complication information within 30 days after the surgery. Each complication included in the index will be recorded as yes or no, and a Clavien-Dindo Grade will be recorded for each complication marked as yes.
Measured: 30 days after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2019
- Study start18 Feb 2020
- Primary completion31 Dec 2024
- Study completion1 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PancreaticoduodenectomyStudies of the same condition, open and under way.
- More trials run by Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jin He, MD,PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04171440
- Sponsor's protocol ID
- J19102
- Other IDs
- IRB00219628
- Status last verified
- Oct 2025
- First submitted
- 19 Nov 2019
- Last updated
- 3 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Slankamenac K, Graf R, Barkun J, Puhan MA, Clavien PA. The comprehensive complication index: a novel continuous scale to measure surgical morbidity. Ann Surg. 2013 Jul;258(1):1-7. doi: 10.1097/SLA.0b013e318296c732.
PubMed 23728278
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Outcomes of Robotic Approach for Pancreaticoduodenectomy: a Multi-center, Prospective, Single Arm, Observational Study
- ClinicalTrials.gov ID
- NCT04171440
- Acronym / sponsor ID
- J19102
- Conditions
- Pancreaticoduodenectomy
- Keywords
- minimally invasive, robotic, surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Study start
- 18 Feb 2020 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 1 Oct 2025 (actual)
- First posted
- 21 Nov 2019 (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.
This is a multi-site prospective, single arm, observational study examining the outcomes of robotic pancreaticoduodenectomy.
Detailed description
This is a multi-site prospective, single arm, observational study examining the outcomes of robotic pancreaticoduodenectomy. Adult patients with symptomatic benign, premalignant, or resectable malignant pathologies recommended for resection after multidisciplinary review and have already chosen to have robotic surgery will be evaluated for enrolling into the study.
Relevant operative, postoperative, and pathologic outcomes will be collected prospectively. The well-established enhanced recovery after pancreaticoduodenectomy pathway currently used in our institution will be applied to all patients postoperatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Minimally Invasive Pancreaticoduodenectomy | Experimental | Procedure: robotic pancreaticoduodenectomyPatients that undergo pancreaticoduodenectomy through small incisions with state-of-the-art robotic-assisted technology. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ≥18 years old
- Symptomatic benign, premalignant, or resectable malignant periampullary and pancreatic tumor requiring resection
- Fit to undergo elective pancreaticoduodenectomy after evaluation by the surgical and anesthesiology teams
- Able to consent to participate in the study
- Appropriate for robotic approach as determined by participating surgeons
Key exclusion criteria (4 listed)
- Arterial (superior mesenteric artery, celiac axis, hepatic artery) or venous involvement (superior mesenteric vein, portal vein) which meets the definition of borderline or unresectable tumor
- Pregnancy
- BMI >40 kg/m2
- Patient requires an additional surgical resection during the index operation (such as hepatectomy or colectomy)
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 |
|---|---|---|
| robotic pancreaticoduodenectomyThe robotic pancreaticoduodenectomy is performed through small incisions using robotic-assisted technology. Pancreaticoduodenectomy is the operation that is necessary to remove tumors of the head and neck of the pancreas, lower portion of the bile duct, and the ampulla of Vater. | Procedure or surgery | Minimally Invasive Pancreaticoduodenectomy |
Primary outcome
Length of hospital stay
Time frame: up to 90 days post intervention
Days from date of intervention to discharge
9 secondary outcomes
Time to functional recovery
Time frame: Day 1 post-intervention to functional recovery
Number of participants experiencing complications
Time frame: Day 90 post-intervention
Operative estimated blood loss
Time frame: During the surgery
Number of participants experiencing pancreaticoduodenectomy-specific complications
Time frame: Day 90 post-intervention
Pathological outcomes as assessed by Pathological response to neoadjuvant therapy
Time frame: Day 90-post intervention
Survival Outcome
Time frame: Overall survival is from surgery to last time of follow-up or death, assessed up to 60 months-post intervention.
Quality of life (QoL) as measured by EQ-5D-3L
Time frame: EQ-5D-3L will be measured at 2 to 4 weeks and 3 to 6 months-post intervention.
Quality of life (QoL) as measured by QLQ-C30 (version 3)
Time frame: QLQ-C30 will be measured at 2 to 4 weeks and 3 to 6 months-post intervention.
Exploratory outcomes
Time frame: 30 days after the surgery
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 3 Oct 2025.
- Background: PubMed 23728278Slankamenac K, Graf R, Barkun J, Puhan MA, Clavien PA. The comprehensive complication index: a novel continuous scale to measure surgical morbidity. Ann Surg. 2013 Jul;258(1):1-7. doi: 10.1097/SLA.0b013e318296c732.
- Individual participant dataSharing planned: No
Related trials for Pancreaticoduodenectomy
Not yet recruitingObservational study
Endoscopic Papillectomy Versus Surgery for Ampullary Tumors: A Prospective Multicenter Cohort Study
Ampullary Neoplasm, Ampullary Adenoma
Recruiting
Stereotactic Body Radiotherapy (SBRT) Induced Pancreatic Atrophy for Prevention of Post Operative Pancreatic Fistulae (POPF) After Pancreatoduodenectomy in Very High-Risk Patients (STEREOPANC)
Pancreatic Surgery, Prophylactic SBRT
Not yet recruitingObservational study
Postoperative Pancreatic Fistula Following Pancreaticoduodenectomy
Pancreaticoduodenectomy
Recruiting
Tissue Adhesive Glue Modified Cyanoacrylate (Glubran® 2) in Soft Pancreas
Pancreatic Cancer, Periampullary Cancer
RecruitingPhase 3
Neoadjuvant vs Upfront Surgery for Resectable Pancreatic Cancer and Periampullary Cancer
Pancreas Cancer, Periampullary Cancer
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.
Jin He, MD,PhD principal investigator
Johns Hopkins University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing robotic pancreaticoduodenectomy in people with Pancreaticoduodenectomy, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 2 sites in United States.
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 5 inclusion and 4 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 3 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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. 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?
Length of hospital stay (time frame: up to 90 days post intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04171440, which also lists 1 linked publication.
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 3 Oct 2025.