Observation of Perioperative Outcomes of Robotic Pancreaticoduodenectomy

Pancreaticoduodenectomy Clinical Trial

Official title:

Perioperative Outcomes of Robotic Approach for Pancreaticoduodenectomy: a Multi-center, Prospective, Single Arm, Observational Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04171440
• Other study ID #: J19102
• Secondary ID: IRB00219628
• Status: Recruiting
• Phase: N/A
• Start date: February 18, 2020
• Est. completion date: December 2024

Study information

• Verified date: June 2024
• Source: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Contact: Jin He, MD,PhD
• Phone: +1(410)614-7551
• Email: jhe11[@]jhmi.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a multi-site prospective, single arm, observational study examining the outcomes of robotic pancreaticoduodenectomy.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 81
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• =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

Exclusion Criteria:

• 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)

Related Conditions & MeSH terms

• Pancreaticoduodenectomy

Intervention

Procedure:
• robotic pancreaticoduodenectomy
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.

Locations

Country	Name	City	State
United States	Johns Hopkins Hospital	Baltimore	Maryland
United States	Atrium Health	Charlotte	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of hospital stay	Days from date of intervention to discharge	up to 90 days post intervention
Secondary	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	Day 1 post-intervention to functional recovery
Secondary	Number of participants experiencing complications	Number of participants who experience Clavien-Dindo Grade III or higher complications	Day 90 post-intervention
Secondary	Operative estimated blood loss	Blood loss during the surgery (unit: ml)	During the surgery
Secondary	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.	Day 90 post-intervention
Secondary	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.	Day 90-post intervention
Secondary	Survival Outcome	Recurrence free outcome is from surgery to recurrence.	Overall survival is from surgery to last time of follow-up or death, assessed up to 60 months-post intervention.
Secondary	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.	EQ-5D-3L will be measured at 2 to 4 weeks and 3 to 6 months-post intervention.
Secondary	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.	QLQ-C30 will be measured at 2 to 4 weeks and 3 to 6 months-post intervention.
Secondary	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.	30 days after the surgery