Safety and Efficacy Evaluation of Single-Port Versus Multi-Port Robotic-Assisted Radical Distal Gastrectomy for Gastric Cancer
2026年9月14日 更新者：First Affiliated Hospital of Wenzhou Medical University
Safety and Efficacy Evaluation of Single-Port Versus Multi-Port Robotic-Assisted Radical Distal Gastrectomy for Gastric Cancer: a Multicenter, Prospective, Open-Label, Randomized Controlled Trial
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.
調査の概要
状態
状態
まだ募集していません
条件
条件
介入・治療
介入・治療
研究の種類
研究の種類
介入
入学 (推定)
入学
212
段階
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
研究連絡先
- 名前：Xian Shen, PhD
- 電話番号：+86 139 6888 8872
- メール：shenxian1120@126.com
研究連絡先のバックアップ
- 名前：Qiantong Dong, PhD
- 電話番号：+86 13676449760
- メール：dongqt2021@wmu.edu.cn
研究場所
-
-
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Beijing、中国
- Beijing Tsinghua Changgung Hospital
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コンタクト：
- Guoxin Li
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Chongqing、中国
- PLA Army Characteristic Medical Center
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コンタクト：
- Fan Li
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Hebei
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Shijiazhuang、Hebei、中国
- The Fourth Hospital of Hebei Medical University
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コンタクト：
- Qun Zhao
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Shandong
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Jinan、Shandong、中国
- Shandong Provincial Hospital Affiliated to Shandong First Medical University
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コンタクト：
- Leping Li
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Zhejiang
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Wenzhou、Zhejiang、中国、325000
- The First Affiliated Hospital of Wenzhou Medical University
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
アーム数
2
武器と介入
参加者グループ / アーム参加者グループ / アーム |
介入・治療介入・治療 |
|---|---|
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実験的：Single-Port Robotic Gastrectomy Group
Participants randomized to this group will undergo single-port robot-assisted radical distal gastrectomy for distal gastric cancer according to the predefined study protocol
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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.
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アクティブコンパレータ：Multi-Port Robotic Gastrectomy Group
Participants randomized to this group will undergo conventional multi-port robot-assisted radical distal gastrectomy for distal gastric cancer according to the predefined study protocol
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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.
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この研究は何を測定していますか？
主要な結果の測定
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Percentage of Participants With Technical Success of the Randomly Assigned Robotic Surgical Approach
時間枠：At the end of surgery
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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.
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At the end of surgery
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二次結果の測定
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Total Operative Time
時間枠：Intraoperative
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Total duration of the surgical procedure, recorded in minutes according to the protocol-defined timing criteria.
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Intraoperative
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Robotic Docking Time
時間枠：Intraoperative
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Duration required for robotic docking, recorded in minutes according to the protocol-defined timing criteria.
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Intraoperative
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Robotic Console Time
時間枠：Intraoperative
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Duration of robotic console operation, recorded in minutes according to the protocol-defined timing criteria.
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Intraoperative
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Intraoperative Blood Loss
時間枠：Intraoperative
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Estimated volume of blood loss during surgery, recorded in milliliters.
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Intraoperative
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Percentage of Participants With Intraoperative Complications
時間枠：Intraoperative
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Intraoperative complications will be recorded and graded according to the Satava classification system.
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Intraoperative
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Percentage of Participants With R0 Resection
時間枠：At completion of postoperative pathological assessment, within 30 days after surgery
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R0 resection is defined as complete tumor resection with no microscopic residual tumor at the resection margins, as determined by postoperative pathological examination.
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At completion of postoperative pathological assessment, within 30 days after surgery
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Number of Lymph Nodes Retrieved
時間枠：At completion of postoperative pathological assessment, within 30 days after surgery
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Total number of lymph nodes retrieved and identified during postoperative pathological examination.
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At completion of postoperative pathological assessment, within 30 days after surgery
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Number of Metastatic Lymph Nodes
時間枠：At completion of postoperative pathological assessment, within 30 days after surgery
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Total number of pathologically confirmed metastatic lymph nodes identified during postoperative pathological examination.
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At completion of postoperative pathological assessment, within 30 days after surgery
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Overall postoperative complications
時間枠：From the end of surgery through 30 days after surgery
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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.
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From the end of surgery through 30 days after surgery
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Percentage of Participants With Clavien-Dindo Grade III or Higher Postoperative Complications
時間枠：From the end of surgery through 30 days after surgery
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Severe postoperative complications are defined as postoperative complications classified as Clavien-Dindo Grade III or higher.
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From the end of surgery through 30 days after surgery
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Specific surgery-related complications
時間枠：From the end of surgery through 30 days after surgery
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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.
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From the end of surgery through 30 days after surgery
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Percentage of Participants With Unplanned Reoperation Within 30 Days After Surgery
時間枠：Within 30 days after surgery
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Percentage of participants requiring an unplanned surgical reoperation for any postoperative reason within 30 days after the index surgery.
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Within 30 days after surgery
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Percentage of Participants With Unplanned Readmission Within 30 Days After Surgery
時間枠：Within 30 days after surgery
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Percentage of participants requiring an unplanned hospital readmission within 30 days after the index surgery.
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Within 30 days after surgery
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Percentage of Participants Who Die Within 30 Days After Surgery
時間枠：Within 30 days after surgery
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All-cause mortality occurring within 30 days after the index surgery.
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Within 30 days after surgery
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Pain and Early Recovery Substudy: Estimated Marginal Mean Resting VAS Pain Score Across Postoperative Days 1-3
時間枠：Postoperative Days 1 through 3
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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.
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Postoperative Days 1 through 3
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Pain and Early Recovery Substudy: Resting VAS Pain Score at 6 Hours After Surgery
時間枠：6 hours after surgery
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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.
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6 hours after surgery
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Pain and Early Recovery Substudy: Resting VAS Pain Score on Postoperative Day 1
時間枠：Postoperative Day 1
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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.
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Postoperative Day 1
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Pain and Early Recovery Substudy: Resting VAS Pain Score on Postoperative Day 2
時間枠：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.
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Postoperative Day 2
|
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Pain and Early Recovery Substudy: Resting VAS Pain Score on Postoperative Day 3
時間枠：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.
|
Postoperative Day 3
|
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Pain and Early Recovery Substudy: Percentage of Participants Requiring Rescue Analgesia
時間枠：From the end of surgery through postoperative Day 3
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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.
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From the end of surgery through postoperative Day 3
|
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Pain and Early Recovery Substudy: Cumulative Postoperative Opioid Consumption in Morphine Milligram Equivalents
時間枠：From the end of surgery through postoperative Day 3
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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.
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From the end of surgery through postoperative Day 3
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Total Abdominal Wall Incision Length
時間枠：At the end of surgery
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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.
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At the end of surgery
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Maximum Length of a Single Abdominal Wall Incision
時間枠：At the end of surgery
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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.
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At the end of surgery
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Time to First Postoperative Flatus
時間枠：Up to 30 days after surgery
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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.
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Up to 30 days after surgery
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Time to First Postoperative Defecation
時間枠：Up to 30 days after surgery
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Time to first postoperative defecation is defined as the time from the end of surgery to the first postoperative bowel movement 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.
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Up to 30 days after surgery
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Time to First Postoperative Ambulation
時間枠：Up to 30 days after surgery
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Time to first postoperative walking lasting more than 5 minutes is defined as the time from the end of surgery to the first postoperative walking episode lasting more than 5 minutes and will be recorded in hours.
Brief standing or walking episodes lasting 5 minutes or less will not be considered as meeting this outcome.
This outcome will be assessed in randomized participants to compare early postoperative functional recovery 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.
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Up to 30 days after surgery
|
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Time to First Postoperative Oral Intake
時間枠：Up to 30 days after surgery
|
Time to first postoperative oral intake is defined as the time from the end of surgery to the first postoperative oral intake of liquid, soft food, or regular food and will be recorded in days.
This outcome will be assessed in randomized participants to compare early postoperative recovery between the single-port and multi-port robotic surgical groups.
|
Up to 30 days after surgery
|
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Time to Meeting Discharge Criteria
時間枠：Up to 30 days after surgery
|
Time to meeting discharge criteria is defined as the time from the end of surgery until the participant meets all prespecified discharge criteria.
These criteria include stable vital signs without fever; recovery of gastrointestinal function with adequate oral intake and no requirement for intravenous nutritional support; ability to ambulate independently without significant discomfort; and satisfactory wound and drainage status with laboratory findings considered clinically acceptable according to the study protocol.
This outcome will be assessed in randomized participants to compare early postoperative recovery between the single-port and multi-port robotic surgical groups.
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Up to 30 days after surgery
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
研究開始
2026年10月1日
一次修了 (推定)
一次修了
2027年10月1日
研究の完了 (推定)
研究の完了
2027年11月1日
試験登録日
最初に提出
最初に提出
2026年9月4日
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
2026年9月14日
最初の投稿 (実際)
最初の投稿
2026年9月18日
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
2026年9月18日
QC基準を満たした最後の更新が送信されました
QC基準を満たした最後の更新が送信されました
2026年9月14日
最終確認日
最終確認日
2026年9月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。