Safety and Efficacy Evaluation of Single-Port Versus Multi-Port Robotic-Assisted Radical Distal Gastrectomy for Gastric Cancer

N/ANot Yet RecruitingNCT07828899

First Affiliated Hospital of Wenzhou Medical University212 enrolled

Overview

This multicenter randomized non-inferiority trial evaluates single-port versus multi-port robotic-assisted radical distal gastrectomy in patients with gastric cancer. A prespecified prospective substudy will assess early postoperative pain, abdominal wall trauma, and early recovery between the two surgical approaches.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

212

Conditions

STOMACH NEOPLASM Robotic Surgical Procedures

Interventions

Single-Port Robot-Assisted Radical Distal GastrectomyPROCEDURE

Participants assigned to this intervention will undergo robot-assisted radical distal gastrectomy using a single-port surgical approach. The surgical procedure will be performed according to the predefined study protocol.

Multi-Port Robot-Assisted Radical Distal GastrectomyPROCEDURE

Participants assigned to this intervention will undergo robot-assisted radical distal gastrectomy using a multi-port surgical approach. The surgical procedure will be performed according to the predefined study protocol.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age 18-85 years, irrespective of sex. * Histologically confirmed primary gastric adenocarcinoma based on endoscopic biopsy. * The primary tumor is located in the middle or distal third of the stomach, or at another site considered amenable to radical distal gastrectomy. Preoperative evaluation indicates that robot-assisted radical distal gastrectomy is technically feasible and that an R0 resection is anticipated. Patients who have received standard neoadjuvant therapy may also be eligible if reassessment confirms fulfillment of the above surgical criteria. * Clinical stage cT1-3N0-1M0 according to the 8th edition of the AJCC TNM staging system for gastric cancer, as assessed by gastroscopy and contrast-enhanced computed tomography of the chest, abdomen, and pelvis, with endoscopic ultrasonography, abdominal magnetic resonance imaging, or diagnostic laparoscopy performed when clinically indicated. Preoperative assessment should indicate that R0 resection can be achieved by distal gastrectomy, with no evidence of adjacent organ invasion or distant metastasis. * No history of other malignancies within the preceding 5 years, except for adequately treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, cervical carcinoma in situ, or other malignancies with a similarly negligible risk of recurrence. * American Society of Anesthesiologists (ASA) physical status class I-III. * Eastern Cooperative Oncology Group performance status (ECOG PS) of 0-1. * Adequate major organ function, with preoperative assessment confirming fitness for general anesthesia and robot-assisted radical distal gastrectomy. * Subjects voluntarily participate in the study, fully understand the trial protocol and provide written informed consent. Exclusion Criteria: * Body mass index (BMI) \>35 kg/m². * Previous gastrectomy, or a history of major upper abdominal surgery considered likely to substantially compromise the feasibility or safety of robot-assisted distal gastrectomy, such as complex hepatobiliary-pancreatic surgery or surgery involving the esophagogastric junction. Previous uncomplicated laparoscopic cholecystectomy, appendectomy, or similar procedures are not, in principle, considered exclusionary. * Tumor-related acute obstruction, active major hemorrhage, or perforation requiring emergency surgery. * Preoperative confirmation of synchronous multiple gastric cancers or remnant gastric cancer, or the presence or history within the preceding 5 years of another active malignancy that may interfere with study treatment or assessment of study endpoints. * Preoperative assessment indicating that radical distal gastrectomy is oncologically or technically inappropriate, including anticipated requirement for total gastrectomy, proximal gastrectomy, combined esophagectomy, or any other procedure other than distal gastrectomy. * Preoperative evaluation or diagnostic laparoscopy demonstrating definite invasion of adjacent organs requiring en bloc multivisceral resection; distant metastasis, including peritoneal, hepatic, pulmonary, osseous, or distant lymph-node metastasis; or positive peritoneal lavage cytology. * Standard preoperative evaluation indicating that the patient is not currently an appropriate candidate for upfront radical distal gastrectomy and requires initiation or continuation of neoadjuvant therapy or other antineoplastic treatment. * Concomitant disease requiring an additional surgical procedure at the time of radical gastrectomy that may substantially affect operative duration, perioperative safety, postoperative recovery, or assessment of the primary endpoint. * Pregnancy or lactation, or planned pregnancy during the study period. * Severe cardiac, pulmonary, hepatic, or renal dysfunction; severe coagulation abnormalities; uncontrolled infection; or any other medical condition considered to preclude safe administration of general anesthesia or surgical treatment. * Inability to provide valid informed consent because of cognitive impairment, psychiatric or mental status abnormalities, or other reasons, or inability to comply with protocol-specified treatment and follow-up procedures. * Any other condition that, in the investigator's judgment, renders the patient unsuitable for participation in the study.

Locations (5)

The Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Shandong Provincial Hospital Affiliated to Shandong First Medical University

Jinan, Shandong, China

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

Beijing Tsinghua Changgung Hospital

Beijing, China

Outcomes

Primary Outcomes

Percentage of Participants With Technical Success of the Randomly Assigned Robotic Surgical Approach

Technical success is defined as completion of the protocol-specified gastrectomy, lymph node dissection, and gastrointestinal reconstruction using the robotic surgical approach assigned at randomization. In the single-port group, technical success requires completion using the single-port robotic system without conversion to multi-port robotic surgery, conventional laparoscopic surgery, or open surgery, and without any unplanned additional port beyond those permitted by the protocol. In the multi-port group, technical success requires completion using the multi-port robotic system without conversion to conventional laparoscopic surgery or open surgery. Failure to complete the assigned robotic procedure because of participant-related, operative, or device-related reasons will be classified as technical failure. The prespecified noninferiority margin is -10 percentage points.

Time frame: At the end of surgery

Secondary Outcomes

Total Operative Time

Total duration of the surgical procedure, recorded in minutes according to the protocol-defined timing criteria.

Time frame: Intraoperative

Robotic Docking Time

Duration required for robotic docking, recorded in minutes according to the protocol-defined timing criteria.

Time frame: Intraoperative

Robotic Console Time

Duration of robotic console operation, recorded in minutes according to the protocol-defined timing criteria.

Time frame: Intraoperative

Intraoperative Blood Loss

Estimated volume of blood loss during surgery, recorded in milliliters.

Time frame: Intraoperative

Central Contacts

Xian Shen, PhD

CONTACT

+86 139 6888 8872 shenxian1120@126.com

Qiantong Dong, PhD

CONTACT

+86 13676449760 dongqt2021@wmu.edu.cn

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

PLA Army Characteristic Medical Center

Chongqing, China

Percentage of Participants With Intraoperative Complications

Intraoperative complications will be recorded and graded according to the Satava classification system.

Time frame: Intraoperative

Percentage of Participants With R0 Resection

R0 resection is defined as complete tumor resection with no microscopic residual tumor at the resection margins, as determined by postoperative pathological examination.

Time frame: At completion of postoperative pathological assessment, within 30 days after surgery

Number of Lymph Nodes Retrieved

Total number of lymph nodes retrieved and identified during postoperative pathological examination.

Time frame: At completion of postoperative pathological assessment, within 30 days after surgery

Number of Metastatic Lymph Nodes

Total number of pathologically confirmed metastatic lymph nodes identified during postoperative pathological examination.

Time frame: At completion of postoperative pathological assessment, within 30 days after surgery

Overall postoperative complications

Any postoperative complication occurring from the end of surgery through postoperative Day 30 will be recorded according to the predefined study protocol and graded using the Clavien-Dindo classification.

Time frame: From the end of surgery through 30 days after surgery

Percentage of Participants With Clavien-Dindo Grade III or Higher Postoperative Complications

Severe postoperative complications are defined as postoperative complications classified as Clavien-Dindo Grade III or higher.

Time frame: From the end of surgery through 30 days after surgery

Specific surgery-related complications

Prespecified surgery-related complications include anastomotic leakage, anastomotic bleeding or stenosis, duodenal stump leakage, pancreatic fistula or postoperative pancreatitis, intra-abdominal bleeding, intra-abdominal infection or abscess, bile leakage, chylous or lymphatic leakage, delayed gastric emptying, postoperative ileus or bowel obstruction, internal hernia, bowel perforation or ischemic necrosis, and wound complications requiring clinical intervention.

Time frame: From the end of surgery through 30 days after surgery

Percentage of Participants With Unplanned Reoperation Within 30 Days After Surgery

Percentage of participants requiring an unplanned surgical reoperation for any postoperative reason within 30 days after the index surgery.

Time frame: Within 30 days after surgery

Percentage of Participants With Unplanned Readmission Within 30 Days After Surgery

Percentage of participants requiring an unplanned hospital readmission within 30 days after the index surgery.

Time frame: Within 30 days after surgery

Percentage of Participants Who Die Within 30 Days After Surgery

All-cause mortality occurring within 30 days after the index surgery.

Time frame: Within 30 days after surgery

Pain and Early Recovery Substudy: Estimated Marginal Mean Resting VAS Pain Score Across Postoperative Days 1-3

This is the prespecified primary outcome of the embedded postoperative pain and early recovery substudy, which is planned to include 140 participants from the parent randomized trial. Resting postoperative pain will be assessed using the Visual Analog Scale (VAS) on postoperative Days 1, 2, and 3 according to a standardized assessment procedure. For the primary analysis, a linear mixed-effects model for repeated measures will be applied, adjusting for pre-specified confounding factors including study site. It will estimate the overall mean resting VAS score across postoperative Days 1-3 for each group, together with the between-group difference and its 95% confidence interval. Higher VAS scores indicate greater pain intensity. The prespecified superiority hypothesis evaluates whether the overall resting VAS pain level across postoperative Days 1-3 is lower in the single-port group than in the multi-port group.

Time frame: Postoperative Days 1 through 3

Pain and Early Recovery Substudy: Resting VAS Pain Score at 6 Hours After Surgery

This is a prespecified supportive outcome of the embedded postoperative pain and early recovery substudy. Resting postoperative pain will be assessed using the Visual Analog Scale (VAS) at 6 hours after surgery according to the standardized assessment procedure. Higher VAS scores indicate greater pain intensity.

Time frame: 6 hours after surgery

Pain and Early Recovery Substudy: Resting VAS Pain Score on Postoperative Day 1

This is a prespecified time-point-specific supportive outcome of the embedded postoperative pain and early recovery substudy. Resting postoperative pain will be assessed using the Visual Analog Scale (VAS) on postoperative Day 1 according to the standardized assessment procedure. VAS scores on postoperative Day 1 will be analyzed separately to compare pain intensity between the single-port and multi-port groups. Where appropriate, estimated marginal means and the between-group difference at postoperative Day 1 will be derived from the prespecified linear mixed-effects model. Multiplicity adjustment will be applied according to the prespecified statistical analysis plan. Higher VAS scores indicate greater pain intensity. This analysis is supportive of the primary longitudinal analysis and does not constitute a separate confirmatory superiority hypothesis.

Time frame: Postoperative Day 1

Pain and Early Recovery Substudy: Resting VAS Pain Score on Postoperative Day 2

This is a prespecified time-point-specific supportive outcome of the embedded postoperative pain and early recovery substudy. Resting postoperative pain will be assessed using the Visual Analog Scale (VAS) on postoperative Day 2 according to the standardized assessment procedure. VAS scores on postoperative Day 2 will be analyzed separately to compare pain intensity between the single-port and multi-port groups. Where appropriate, estimated marginal means and the between-group difference at postoperative Day 2 will be derived from the prespecified linear mixed-effects model. Multiplicity adjustment will be applied according to the prespecified statistical analysis plan. Higher VAS scores indicate greater pain intensity. This analysis is supportive of the primary longitudinal analysis and does not constitute a separate confirmatory superiority hypothesis.

Time frame: Postoperative Day 2

Pain and Early Recovery Substudy: Resting VAS Pain Score on Postoperative Day 3

This is a prespecified time-point-specific supportive outcome of the embedded postoperative pain and early recovery substudy. Resting postoperative pain will be assessed using the Visual Analog Scale (VAS) on postoperative Day 3 according to the standardized assessment procedure. VAS scores on postoperative Day 3 will be analyzed separately to compare pain intensity between the single-port and multi-port groups. Where appropriate, estimated marginal means and the between-group difference at postoperative Day 3 will be derived from the prespecified linear mixed-effects model. Multiplicity adjustment will be applied according to the prespecified statistical analysis plan. Higher VAS scores indicate greater pain intensity. This analysis is supportive of the primary longitudinal analysis and does not constitute a separate confirmatory superiority hypothesis.

Time frame: Postoperative Day 3

Pain and Early Recovery Substudy: Percentage of Participants Requiring Rescue Analgesia

This is a prespecified secondary or supportive outcome of the embedded postoperative pain and early recovery substudy. Rescue analgesia is defined as additional analgesic treatment administered because of inadequate pain control beyond the protocol-specified routine postoperative analgesic regimen. The proportion of participants requiring at least one rescue analgesic intervention during the prespecified postoperative observation period will be recorded and compared between the single-port and multi-port groups. This outcome does not have a separate confirmatory superiority hypothesis.

Time frame: From the end of surgery through postoperative Day 3

Pain and Early Recovery Substudy: Cumulative Postoperative Opioid Consumption in Morphine Milligram Equivalents

This is a prespecified secondary or supportive outcome of the embedded postoperative pain and early recovery substudy. All postoperative opioid analgesics administered during the prespecified observation period will be recorded. Individual opioid doses will be converted to morphine milligram equivalents (MME) using a prespecified standardized conversion method, and cumulative MME will be calculated for each participant to allow quantitative comparison of postoperative opioid requirements between the single-port and multi-port groups. This outcome does not have a separate confirmatory superiority hypothesis.

Time frame: From the end of surgery through postoperative Day 3

Total Abdominal Wall Incision Length

Total abdominal wall incision length will be calculated as the sum of the lengths of all abdominal surgical incisions and recorded in centimeters according to the standardized study assessment procedure. This outcome will be assessed in randomized participants to compare abdominal wall trauma between the single-port and multi-port robotic surgical groups. It is also included as a prespecified supportive outcome of the embedded postoperative pain and early recovery substudy.

Time frame: At the end of surgery

Maximum Length of a Single Abdominal Wall Incision

The length of the longest individual abdominal wall surgical incision will be measured in centimeters according to the standardized study assessment procedure. This outcome will be assessed in randomized participants to compare the extent of abdominal wall trauma between the single-port and multi-port robotic surgical groups. It is also included as a prespecified supportive outcome of the embedded postoperative pain and early recovery substudy.

Time frame: At the end of surgery

Time to First Postoperative Flatus

Time to first postoperative flatus is defined as the time from the end of surgery to the first passage of flatus and will be recorded in hours. This outcome will be assessed in randomized participants to compare early postoperative gastrointestinal recovery between the single-port and multi-port robotic surgical groups.