ChiCTR2600123459 版本V1.0 版本创建时间2026/04/27 11:23:54 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

ChiCTR2600123459 

最近更新日期：

Date of Last Refreshed on：

2026-04-27 11:23:48 

注册时间：

Date of Registration：

2026-04-27 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

维生素B1对直肠癌全直肠系膜切除术后肠道功能恢复的临床研究

Public title：

Clinical study of vitamin B1 on intestinal function recovery after total mesorectal excision for rectal cancer

注册题目简写：

English Acronym：

研究课题的正式科学名称：

维生素B1对直肠癌全直肠系膜切除术后肠道功能恢复的临床研究

Scientific title：

Clinical study of vitamin B1 on intestinal function recovery after total mesorectal excision for rectal cancer

研究课题代号(代码)：

Study subject ID：

在二级注册机构或其它机构的注册号：

The registration number of the Partner Registry or other register：

申请注册联系人：

康健 

研究负责人：

康亮 

Applicant：

Jian Kang 

Study leader：

Liang Kang 

申请注册联系人电话：

Applicant telephone：

+86 136 0002 1695

研究负责人电话：

Study leader's telephone：

+86 136 0288 6833

申请注册联系人传真 ：

Applicant Fax：

研究负责人传真：

Study leader's fax：

申请注册联系人电子邮件：

Applicant E-mail：

kangj33@mail2.sysu.edu.cn

研究负责人电子邮件：

Study leader's E-mail：

kangl@mail.sysu.edu.cn

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

申请注册联系人通讯地址：

中国广东省广州市天河区员村二横路26号

研究负责人通讯地址：

中国广东省广州市天河区员村二横路26号

Applicant address：

26 Erheng Road, Yuancun Village, Tianhe District, Guangzhou, Guangdong, China

Study leader's address：

26 Erheng Road, Yuancun Village, Tianhe District, Guangzhou, Guangdong, China

申请注册联系人邮政编码：

Applicant postcode：

研究负责人邮政编码：

Study leader's postcode：

申请人所在单位：

中山大学附属第六医院

Applicant's institution：

The Sixth Affiliated Hospital of Sun Yat-sen University

研究负责人所在单位：

中山大学附属第六医院

Affiliation of the Leader：

The Sixth Affiliated Hospital of Sun Yat-sen University

是否获伦理委员会批准：

是/Yes

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

2026ZSLYEC-017

伦理委员会批件附件：

Approved file of Ethical Committee：

 查看附件View

批准本研究的伦理委员会名称：

中山大学附属第六医院医学伦理委员会

Name of the ethic committee：

Medical Ethics Committee of the Sixth Affiliated Hospital of Sun Yat-sen University

伦理委员会批准日期：

Date of approved by ethic committee：

2026-01-06 00:00:00

伦理委员会联系人：

吴倩

Contact Name of the ethic committee：

Qian Wu

伦理委员会联系地址：

中国广东省广州市天河区员村二横路26号

Contact Address of the ethic committee：

26 Erheng Road, Yuancun Village, Tianhe District, Guangzhou, Guangdong, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 186 7588 7011

伦理委员会联系人邮箱：

Contact email of the ethic committee：

zslyllb@mail.sysu.edu.cn

研究实施负责（组长）单位：

中山大学附属第六医院

Primary sponsor：

The Sixth Affiliated Hospital of Sun Yat-sen University

研究实施负责（组长）单位地址：

中国广东省广州市天河区员村二横路26号

Primary sponsor's address：

26 Erheng Road, Yuancun Village, Tianhe District, Guangzhou, Guangdong, China

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

广东

市(区县)：

广州

Country：

China

Province：

Guangdong

City：

Guangzhou

单位(医院)：

中山大学附属第六医院

具体地址：

中国广东省广州市天河区员村二横路26号

Institution
hospital：

The Sixth Affiliated Hospital of Sun Yat-sen University

Address：

26 Erheng Road, Yuancun Village, Tianhe District, Guangzhou, Guangdong, China

经费或物资来源：

无

Source(s) of funding：

None

Target disease：

Rectal cancer

Target disease code：

ICD-10-CM C20

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 其它 

Study phase：

N/A

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

明确维生素 B1 肌肉注射促进直肠癌全直肠系膜切除术后肠道功能恢复的安全性、有效性和可行性。  

Objectives of Study：

To clarify the safety, effectiveness, and feasibility of vitamin B1 intramuscular injection in promoting the recovery of bowel function after total mesorectal excision for rectal cancer.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

入选时满足下列所有条件方可入组： 1）初诊患者，年龄 18-75 岁； 2）病人或家属，能够理解研究方案并愿意参与本研究，提供书面知情同意； 3）ASA 评分 I-III 级；ECOG（东部肿瘤协作组）量表的表现状态为 0 或 1； 4）结肠镜病理活检证实为腺癌（包括管状腺癌、乳头状腺癌、黏液腺癌、印戒细胞癌）； 5）根据美国癌症联合委员会（AJCC）癌症分期手册第八版，术前评估肿瘤临床分期 T1-T3N+M0，需行全直肠系膜切除术（TME）的患者。

Inclusion criteria

Participants were eligible for enrollment only if they met "all" of the following criteria at the time of screening: 1. Newly diagnosed, treatment-naive patients aged 18 to 75 years; 2. Patients or their legally authorized representatives (LARs) are able to fully comprehend the study protocol, voluntarily agree to participate in this trial, and provide written informed consent prior to the performance of any study-related procedures; 3. American Society of Anesthesiologists (ASA) physical status classification grade I to III; Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1; 4. Histopathologically confirmed rectal adenocarcinoma via colonoscopic biopsy, including the following histological subtypes: tubular adenocarcinoma, papillary adenocarcinoma, mucinous adenocarcinoma, and signet-ring cell carcinoma; 5. Patients with preoperatively clinically staged T1-T3, node-positive (N+), non-metastatic (M0) rectal cancer, in accordance with the 8th edition of the American Joint Committee on Cancer (AJCC) Cancer Staging Manual, and who are scheduled to undergo standardized total mesorectal excision (TME).

排除标准：

排除标准：入选时符合以下标准的患者需从本试验中排除 1）长期饮酒史； 2）怀孕或哺乳期； 3）计划进行硬膜外麻醉； 4）已知或怀疑对维生素 B1 过敏； 5）计划在维生素 B1 肌肉注射的同时局部或全身持续输注维生素 B1； 6）接受过任何新辅助放疗的直肠癌患者； 7）既往已行直肠手术，或急性肠梗阻或同步腹部手术的迹象； 8）5 年内有 FAP、活动性 IBD 或其他癌症病史； 9）在主要手术期间形成任何新造口的术前手术计划； 10）目前严重肝功能障碍（Child 分级 A 级或以上），肾功能衰竭（eGFR<30）； 11）任何可能妨碍遵守研究方案或随访计划的心理、家庭、社会或地理条件； 12）在入组时或研究期间参加其他药物或器械试验。

Exclusion criteria：

Exclusion Criteria: Patients who met the following criteria at enrollment were excluded from the trial 1) long-term drinking history; 2) pregnancy or lactation; 3) planned epidural anesthesia; 4) known or suspected allergy to vitamin B1; 5) plan for local or systemic continuous vitamin B1 infusion concurrently with vitamin B1 intramuscular injection; 6) patients with rectal cancer who had received any neoadjuvant radiotherapy; 7) prior rectal surgery, or signs of acute intestinal obstruction or concurrent abdominal surgery; 8) history of FAP, active IBD, or other cancers within 5 years; 9) forming a preoperative surgical plan for any new stoma during the primary surgery; 10) current severe liver dysfunction (Child grade A or above) and renal failure (eGFR<30); 11) any psychological, family, social or geographic conditions that may prevent adherence to the study protocol or follow-up plan; 12) participated in other drug or device trials at the time of enrollment or during the study.

研究实施时间：

Study execute time：

从 From 2026-01-06 00:00:00至 To 2029-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2026-05-01 00:00:00 至 To 2029-12-31 00:00:00  

干预措施：

Interventions：

组别：

维生素B1组

样本量：

296

Group：

Vitamin B1 group

Sample size：

干预措施：

术后8h起，100mg维生素B1肌肉注射，每日一次，达到GI-3恢复或术后7天停药。

干预措施代码：

Intervention：

Beginning at 8 hours after the completion of the index total mesorectal excision (TME), patients in the intervention group received intramuscular injection of 100 mg vitamin B1 (thiamine) once daily. Treatment was discontinued upon achievement of GI-3 grade bowel function recovery or on postoperative day 7, whichever occurred first.

Intervention code：

组别：

空白对照组

样本量：

296

Group：

Blank control group

Sample size：

干预措施：

无

干预措施代码：

Intervention：

None

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 广东 

市(区县)：

  

Country：

China 

Province：

Guangdong 

City：

 

单位(医院)：

中山大学附属第六医院 

单位级别：

三甲 

Institution
hospital：

The Sixth Affiliated Hospital of Sun Yat-sen University

Level of the institution：

tertiary care hospital

测量指标：

Outcomes：

指标中文名：

术后72h内达到GI-3恢复的比例

指标类型：

主要指标

Outcome：

Achieved GI-3 recovery by 72h after operation

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

GI-3恢复时间

指标类型：

次要指标

Outcome：

Time to GI-3 recovery

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

GI-3恢复时间

指标类型：

次要指标

Outcome：

Time to GI-2 recovery

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

术后延长肠梗阻（PPOI）发生率

指标类型：

次要指标

Outcome：

Prolonged postoperative Ileus

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

术后30天内综合并发症指数（CCI）

指标类型：

次要指标

Outcome：

Comprehensive Complication Index (CCI) within 30 days postoperatively

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

维生素B1相关不良反应发生率

指标类型：

次要指标

Outcome：

Incidence of Vitamin B1 (Thiamine)

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

首次排气时间

指标类型：

次要指标

Outcome：

Time to first flatus

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

首次排便时间

指标类型：

次要指标

Outcome：

Time to first defecation

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

口服耐受食物时间

指标类型：

次要指标

Outcome：

Time to tolerance of solid oral diet

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

住院时间

指标类型：

次要指标

Outcome：

Postoperative length of hospital stay (LOS) after the index TME procedure

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

住院费用

指标类型：

次要指标

Outcome：

Postoperative hospitalization costs

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

术后24h阿片类药物使用量

指标类型：

次要指标

Outcome：

Intraoperative opioid analgesia

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

术后7天镇痛总获益OBAS评分

指标类型：

次要指标

Outcome：

OBAS score

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

术后恢复质量QoR-15评分

指标类型：

次要指标

Outcome：

Quality of Recovery–15

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

术后生活质量EQ-5D-5L评分

指标类型：

次要指标

Outcome：

Quality of life (EQ-5D-5L)

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

达到医学定义的出院时间标准

指标类型：

次要指标

Outcome：

Time to meet clinician-assessed medical criteria for discharge from hospital

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

病人自我评估出院准备情况的时间

指标类型：

次要指标

Outcome：

Time to patient-assessed fitness for discharge from hospital

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

加速康复外科（ERAS）依从性

指标类型：

次要指标

Outcome：

Enhanced recovery perioperative procedures

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

无

组织：

Sample Name：

None

Tissue：

人体标本去向

 其它  

说明

Fate of sample：

0thers  

Note：

征募研究对象情况：

Recruiting status：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 75 岁 years

性别：

男女均可

Gender：

Both

随机方法（请说明由何人用什么方法产生随机序列）：

本研究采用随机、双盲、平行对照、优效性临床研究设计。 干预措施的随机分配分组方法: 1).分配序列产生:由电脑软件RandomAlloc产生随机数字。 2).分配隐藏机制:分组按照随机数字表顺序编码。 3).分配实施:本研究采用随机数字表的方法,由电脑软件RandomAlloc产生随机数字,由随机化管理员管理随机数字表。受试者筛选合格并签署知情同意书后,研究者向随机化管理员申请随机化数字进行分组,在病例报告表中登记患者姓名缩写、性别、年龄、住院号及随机号。随机分层因素包括:研究中心、肿瘤cT分期,肿瘤cN分期和肿瘤位置。

Randomization Procedure (please state who generates the random number sequence and by what method)：

Randomization and Allocation This was a randomized, double-blind, parallel-group, superiority clinical trial. The random number sequence was generated using RandomAlloc software, with a stratified randomization approach (stratification factors: study center, cT stage, cN stage, tumor location) and 1:1 allocation to the intervention and control groups. Allocation concealment was maintained via sequential coding of the random number table, which was held exclusively by an independent randomization manager with no involvement in trial implementation. After eligibility confirmation and written informed consent, the investigator requested a unique random number from the randomization manager for treatment allocation, with participant details and random number recorded in the CRF immediately after randomization.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：

本研究为一项双盲、随机安慰剂对照临床试验，全程遵循 CONSORT 2010 声明执行。自受试者随机入组至数据库锁定、主要终点统计分析完成前，对受试者、结局评估员、研究护士、数据统计师全程设盲；实施 TME 手术的手术医师不参与药物给药、终点评估与数据分析，全程无权获取受试者分组信息。 为保障盲法完整性，维生素 B1 注射液与 0.9% 氯化钠安慰剂由 GMP 认证企业制备，二者外观、剂型、包装、给药方式完全一致。随机序列由独立统计师生成，对应编号的试验药物由研究中心药房专人按随机序列发放，不向设盲人员披露分组信息。所有术后肠道功能终点均由设盲的独立评估员采集评价，统计分析由设盲的统计师基于锁定的匿名化数据集完成。 正式揭盲分两级完成，一级揭盲披露分组标签完成统计分析，二级揭盲明确干预与对照分组，数据库锁定前严禁正式揭盲。仅受试者出现危及生命的紧急情况时可启动紧急揭盲，全程完整记录，揭盲受试者按方案退出研究，且不向其他设盲人员披露相关信息。试验结束后通过盲法猜测问卷验证盲法完整性，采用统计学方法确认试验全程无显著破盲情况。

Blinding：

Blinding Procedures This trial was conducted as a double-blind, randomized, placebo-controlled trial in accordance with the CONSORT 2010 statement. Participants, outcome assessors, study nurses, and data statisticians were blinded to group allocation throughout the study until database lock and completion of the primary statistical analysis. Operating surgeons performing total mesorectal excision were not involved in drug administration, outcome assessment, or data analysis, and had no access to group allocation information. To ensure blinding integrity, Vitamin B1 (Thiamine) injection and matching 0.9% normal saline placebo were manufactured with identical appearance, volume, packaging, labeling, and administration route. The randomization sequence was generated by an independent statistician, and the numbered investigational products were dispensed by the trial center pharmacy strictly according to the randomization code, with no group information disclosed to blinded trial personnel. All perioperative bowel function endpoints were assessed by independent blinded outcome assessors, and all statistical analyses were performed by a blinded statistician on the locked anonymized dataset. Formal unblinding was conducted in two stages after completion of the primary analysis. Emergency unblinding was only permitted for life-threatening adverse events, with full documentation of the unblinding process, and unblinded participants were withdrawn from the trial. Blinding integrity was verified via a post-trial questionnaire for participants and outcome assessors, with statistical testing to confirm no significant breach of blinding.

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

是否共享原始数据：

IPD sharing

No

共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：

无

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

None

数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：

所有资料均应及时、如实、详细地纪录在病历登记表（Case Report Form，CRF）中。监督员将检查 CRF 的完整性和准确性，并进行必需的修改或补充。在临床试验中，需要将规定的观察或检查项目记录在病例报告表中。病例报告表中的内容须与原始资料完全一致，对于由原始资料计算所得的结果，其计算的依据应可以溯源。 我院已建立完善的电子版结直肠癌数据库系统及随访系统，文本项目从 CRF 输入数据库之后只能手动核对。数据管理人员对输入数据库的信息进行系统检查。数据在输入完成将被锁定。此后任何对数据库的改动只能经由获得临床研究领导者、研究统计学家和数据管理者联合书面同意才可实现。

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

All study-related data were documented in a timely, accurate, and detailed manner in the Case Report Form (CRF). The dedicated Clinical Research Associate (CRA) performed regular on-site audits to verify the completeness and accuracy of all CRF entries, and implemented necessary corrections or supplemental documentation in accordance with the study protocol and Good Clinical Practice (GCP) guidelines. All pre-specified observational endpoints and laboratory assessment items outlined in the study protocol were recorded in the CRF throughout the trial period. All entries in the CRF were fully consistent with the corresponding original source documents. For any outcomes derived from calculations based on source data, the full calculation methodology and underlying rationale were fully traceable to the original source records. Our institution has established a validated electronic colorectal cancer database and standardized follow-up system. All data fields were manually entered into the database from the finalized CRF, followed by mandatory independent manual verification. Independent data managers performed systematic, full-coverage quality checks on all data entered into the database to identify and resolve data queries, outliers, and missing values. The database was formally locked after completion of all data entry, full source data verification, and resolution of all outstanding data queries. No amendments, alterations, or modifications to the locked database were permitted at any point thereafter, unless a formal written request was reviewed and approved jointly by the principal investigator (PI), the study biostatistician, and the lead data manager.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2026-04-27 11:23:48