Clinical trial: NCT03138213
Section: Confidentiality
Subsections: Viii. The Confidentiality Of Clinical Data

Your medical records (research medical records, CRF, test results, etc.) will be kept completely at the hospital where you are attending. The doctor will record the results of the tests and other tests on your medical record. Researchers, ethics committees, and higher-level medical administrations will be allowed to access your medical records. Any public report about the results of this study will not disclose your personal identity. We will make every effort to protect the privacy of your personal medical information to the extent permitted by law. According to medical research ethics, in addition to personal privacy information, experimental data will be available for public inquiry and sharing. Query and sharing will be limited to web-based electronic databases, ensuring that no personal privacy information will be disclosed.
Clinical trial: NCT03138213
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: Vi. Adverse Reactions, Risks And Protective Measures For Participating In The Study|六、参加研究的不良反应、风险及保护措施

During the trial, if there is any discomfort in the study, or the condition changes, or any unexpected situation, regardless of whether it is related to treatment, you should promptly notify your doctor, he/she will make an accurate judgment and medical treatment. deal with. The main adverse reactions and risks are as follows:
1. In the operation, the surgical method is determined according to medical conditions according to the condition; 2. Due to the patient's condition (critical, complicated, poor systemic conditions), individual differences, sudden and sudden recession may occur during and after surgery, multiple organ failure (such as heart failure, respiratory failure, liver failure, renal function) Failure, DIC, etc.) or unpredictable changes in the condition can be life-threatening; 3. Major bleeding, hemorrhagic shock may occur during surgery, and life-threatening; 4. The operation is due to anatomical variation and severe adhesion for therapeutic purposes.  
It may be inevitable to damage surrounding and nearby tissues and organs, and the corresponding organs need to be repaired or reconstructed; 5. Special medical supplies such as chemotherapy pumps, anastomotic devices, etc. may be used during surgery, and special treatments such as radiofrequency therapy and cryotherapy may be used during surgery; 6. Tumor patients may not be able to undergo surgical resection due to the condition, or recurrence and metastasis after resection, requiring further treatment; 7. Recurrent bleeding after surgery, local, systemic infection, bile leakage, pancreatic leakage, intestinal leakage, anastomotic leakage and other changes in the condition may be life-threatening and require reoperation if necessary; 8. Other unforeseen or unpredictable adverse consequences and medical risks; 9. may need to be admitted to the ICU ward if necessary after surgery; 10. Postoperative examination may be inconsistent with preoperative diagnosis and intraoperative diagnosis. The final diagnosis is based on postoperative examination; 11. Determine the risk of biopsy of the lesion under the endoscope under the condition of the operation; 12. During the operation, malignant tumor metastasis is found, and it is difficult to cure radically or radically. The risk of radical resection is great. Only palliative anastomosis is possible.  
13. During the operation, the abdominal cavity is widely metastasized, and it is impossible to perform resection or palliative anastomosis.  
14. Postoperative abdominal adhesions, intestinal adhesions, intestinal obstruction, may require relevant treatment; 15. Long-term bed rest, pulmonary infection, and deep vein thrombosis may occur; 16. Incision healing may occur after surgery, infection of the incision, incision splitting, incisional hernia, etc.;  
Informed Consent Version date2018-03-20 Ver 1.0 17. Pancreatic exocrine insufficiency; 18. Laparoscopic pancreaticoduodenectomy may be due to tissue adhesion, intraoperative bleeding, etc.  
19. Pneum abdominal syndrome, etc.;
Protection measures, if the patients participating in the trial have the above complications, they will form a professional medical team to deal with and treat them for the first time.

参加本项试验期间,如果在研究中出现任何不适,或病情变化,或出现任何 意外情况,不管是否与治疗有关,均应及时通知您的医生,他/她将对此做出准 确判断及医疗处理。主要的不良反应及风险陈述如下:
1. 手术中根据病情按医疗原则确定手术方式; 2. 因患者病情(危重、复杂、全身条件差)、个体差异,手术中、手术后可能 发生隐性疾患突发,多器官功能衰竭(如心功能衰竭、呼吸衰竭、肝功能 衰竭、肾功能衰竭、DIC 等)或者发生难以预料的病情变化,可危及生命; 3. 手术中可能发生大出血、失血性休克,危及生命; 4. 手术因解剖变异、严重粘连,为了达到治疗目的。可能无法避免地损伤周 围及附近组织器官,需要对相应的器官进行修补或重建; 5. 手术中可能使用特殊医疗用品,如化疗泵、吻合器械等,手术中可能使用 特殊治疗,如射频治疗、冷冻治疗等; 6. 肿瘤患者因病情可能无法手术切除,或切除后复发转移,需进一步治疗; 7. 手术后可能发生再出血,局部、全身感染,胆漏,胰漏、肠漏,吻合口漏 以及其他病情变化,可能危及生命,必要时需再次手术; 8. 其他无法预料或者不能防范的不良后果和医疗风险; 9. 术后必要时可能需送入 ICU 病房;  
10. 术后病检可能与术前诊断,术中诊断不一致,最终诊断以术后病检为准; 11. 根据术中情况判断腔镜下病灶穿刺活检风险; 12. 术中发现恶性肿瘤转移,难以根治性切除或者根治性切除风险巨大,仅行 姑息性吻合手术可能; 13. 术中见腹腔广泛转移,无法进行切除或姑息性吻合手术,仅开关腹可能; 14. 术后腹腔粘连,肠粘连、肠梗阻,需要相关治疗可能; 15. 术后长期卧床,肺部感染,深静脉血栓形成可能;
16. 术后可能发生切口愈合不良,切口感染,切口裂开,切口疝等; 17. 胰腺外分泌功能不全; 18. 腹腔镜胰十二指肠切除术因为组织粘连,术中出血等存在中转开腹可能; 19. 气腹综合征等; 保护措施,参加试验的患者如若出现上述的并发症,会组成专业医疗团队第 一时间 进行处理及治疗。
Clinical trial: NCT03138213
Section: Procedures
Subsections: Iv. What Will Be Done If You Participate In The Research?

If you meet the inclusion criteria and agree to participate, you will be tested according to the following steps: divided into two groups according to the study plan, respectively, undergoing laparoscopic and open surgery, both groups undergo pancreaticoduodenectomy, you may be assigned In any group, whether you are enrolling or operating in surgery, your interests will be the first consideration. All patients underwent routine nursing of biliary and pancreatic surgery, and collected various indexes before, during and after surgery, including but not limited to blood routine, blood biochemistry, tumor markers, blood loss, anastomosis, and complications. Conduct safety and efficacy assessments and judgments. At the same time, follow-up for 24 months. The time points of follow-up were: January, March, June, December, August, and 24 months after discharge. The follow-up method was ward follow-up combined with telephone follow-up. The follow-up included but not limited to the condition/treatment/combination medication and all adverse events.
Clinical trial: NCT03138213
Section: Purpose of Research
Subsections: Research Introduction I. **Research Background And Research Purposes** 1. Research Background|知情同意书 告知页 尊敬的女士/先生: 研究介绍: 一、研究背景和研究目的 1. 研究背景

Pancreaticoduodenectomy (PD) is one of the most complicated surgical procedures in abdominal surgery. It includes not only the removal of the head of the pancreas, the common bile duct, the distal stomach, the duodenum, the proximal jejunum, the gallbladder and other organs. It also involves the tedious reconstruction of the digestive tract. It is considered to be the standard surgical method for the treatment of pancreatic head tumors, lower common bile duct tumors, duodenal tumors and other diseases. Due to the change of surgical instruments and the improvement of surgical techniques, Minimally invasive surgery (MIS) is increasingly used in pancreatic surgery. First reported by Gagner et al., the first laparoscopic pancreaticoduodenectomy was performed in 1994. Then more and more laparoscopic pancreatic surgery is gradually carried out. Many scholars believe that compared with traditional open surgery, laparoscopic surgery has the advantages of less impact on patients, shorter hospital stay, less intraoperative blood loss, etc. Can achieve oncological prognosis and long-term survival similar to open surgery. However, laparoscopic surgery also has problems such as long operation time and high cost. To date, many studies have shown that 3D laparoscopic techniques have significant advantages in gastric, renal, and cervical surgery. However, there are few reports on its application in pancreatic surgery. Only a few meta-analyses were compared  
Informed Consent Version date2018-03-20 Ver 1.0 between laparoscopic and open surgery, but the quality of the included literature was not high.  
However, the current research has some shortcomings. Different types of surgical methods were collectively referred to as minimally invasive surgery. The baselines of patients were different between different studies. Most of the studies included a small number of patients, high data heterogeneity, and different levels of surgery. The method did not give specific reports and the study could not provide detailed oncology results and long-term follow-up data.

首先,感谢您对我们这项临床研究的关注!我们将邀请您参加一项腹腔镜和 开腹胰十二指肠切除术的随机化对照临床试验。在您决定是否参加这项研究之前, 请尽可能仔细阅读以下内容,它可以帮助您了解该项研究以及为何要进行这项研 究、研究的流程和期限、参加本研究后可能给您带来的益处、风险和不适。如果 您愿意,您也可以和您的家属、朋友讨论,或者请您的医生给予解释。  
胰十二指肠切除术(Pancreaticoduodenectomy, PD),是腹部外科最复杂的手术 方式之一,它不仅包含切除胰头、胆总管、远端胃、十二指肠、近端空肠、胆囊 等器官,还涉及到了繁琐的消化道重建。被认为是治疗胰头肿瘤,胆总管下段肿 瘤,十二指肠肿瘤等疾病的标准手术方式。  
由于手术器械的更迭以及手术技巧的提升,微创手术(Minimally invasive surgery, MIS)被越来越多的运用于胰腺外科中。由 Gagner 等人率先报道,1994 年 首次开展第一例腹腔镜下胰十二指肠切除术。而后越来越多的腔镜胰腺手术逐渐 开展,许多学者认为腹腔镜手术在与传统的开放手术相比,有对病人打击小,住 院时间缩短,术中出血量少等优点;与此同时还能获得与开放手术相似的肿瘤学 预后及远期生存期。但是,腹腔镜手术也存在手术时间长,花费高等不可回避的 问题。迄今为止,许多研究已表明 3D 腹腔镜技术在胃、肾脏以及宫颈手术方面 优势明显。然而关于其在胰腺外科的应用报道甚少。仅有几篇荟萃分析做了腹腔 镜和开腹手术的比较,然而纳入的文献质量不高。  
然而,目前研究存在以下一些不足。将不同类型的手术方式统称为微创手术 进行分析,不同研究间患者的基线并不相同,大部分研究纳入的患者数目较小, 数据的高度异质性,手术水平存在差异,不同中心对于手术方式并未给出具体报 道以及研究不能详细的提供肿瘤学结果及长期的随访资料。
Clinical trial: NCT03138213
Section: Voluntary Participation
Subsections: Ii. Who Can Participate In This Study?|Iii. Who Is Not Suitable For Research?

1. The patient is ≥18 years old and younger than 75 years old; 2. Highly suspected or histological evidence of pancreas, bile duct, duodenal malignancy, etc.; 3. Those who are highly suspected of malignant tumors but unable to obtain pathological evidence; 4. Benign lesions originate from the pancreas, bile duct, duodenum, stomach and other pancreaticoduodenectomy; 5. The assessment team assessed no significant vascular invasion based on abdominal imaging data before surgery; 6. The subject understands and can cooperate with the study; 7. Subjects can provide and sign written informed consent prior to conducting research-related operations; 8. According to the NCCN guidelines, patients will benefit from this therapeutic procedure.

1. Preoperative or intraoperative confirmation of distant metastasis of the tumor: intraperitoneal  
Informed Consent Version date2018-03-20 Ver 1.0 implantation, distant lymph node metastasis, liver or other organ metastasis; 2. Subjects need to undergo pancreatic body resection, middle pancreatic resection or total pancreatectomy and other surgical methods; 3. According to the American Society of Anesthesiologists (ASA) the score greater than 4 points, there is a high degree of surgical risk; 4. The vascular invasion was assessed by the assessment team based on abdominal imaging data before surgery, and patients requiring combined vascular resection during surgery; 5. Patients with other tumors at the same time; 6. Radical surgery cannot benefit, only palliative surgery will done;
Clinical trial: NCT03138213
Section: Withdrawal from Study
Subsections: X. You Can Voluntarily Choose To Participate In Research And Withdraw From The Study

Whether or not to participate in the research is entirely up to you. You may decline to participate in the study or withdraw from the study at any time during the study, which will not affect your relationship with the doctor and will not affect your medical or other benefits. For your best interest, your doctor or researcher may discontinue your participation in this study at any time during the course of your research.