Trial Title:
Prospective Study on Double-Stapling End-to-End Gastroduodenostomy Billroth-I Anastomosis in Laparoscopy-Assisted Surgery for Locally Advanced Distal Gastric Cancers
NCT ID:
NCT05545293
Condition:
Advanced Gastric Carcinoma
Conditions: Official terms:
Stomach Neoplasms
Conditions: Keywords:
anastomotic leakage
laparoscopy-assisted surgery
double-stapling end-to-end gastroduodenostomy
Billroth-I anastomosis
anastomotic stenosis
Study type:
Observational [Patient Registry]
Overall status:
Unknown status
Study design:
Time perspective:
Prospective
Summary:
The purpose of this study is to explore the clinical application value of Double-Stapling
End-to-End Gastroduodenostomy Billroth-I Anastomosis in Laparoscopy-Assisted Surgery for
Locally Advanced Distal Gastric Cancers.
Detailed description:
As one of the core contents of gastric cancer surgery, the choice of digestive tract
reconstruction method has always been the focus of clinical research in gastric cancer
surgery. There are many alternative methods of digestive tract reconstruction at present,
but there is no absolute superiority among various reconstruction methods. According to
the individual characteristics of patients, the selection of appropriate digestive tract
reconstruction methods should be an important direction in the future research field of
digestive tract reconstruction.
There are many methods of digestive tract reconstruction in distal gastrectomy, including
Billroth-I anastomosis, Billroth-II anastomosis and Roux-en-Y anastomosis. However, the
standard method of reconstruction after distal subtotal gastrectomy does not reach a
consensus. According to Korean Practice Guideline for Gastric Cancer 2018,
gastroduodenostomy and gastrojejunal anastomosis are recommended after distal subtotal
gastrectomy for middle-low gastric cancer, but the priority of different surgical
procedures is not clarified. The conclusion is that there is no significant difference
between the Billroth-I, Billroth-II and Roux-en-Y in postoperative quality of life,
nutritional status and long-term prognosis of patients. Roux-en-Y anastomosis has a lower
incidence of bile reflux, but a higher incidence of delayed gastric emptying compared
with Billroth-I and Billroth-II. Similarly, the Japanese gastric cancer treatment
guidelines in 2018 did not specify the priority of reconstruction methods after distal
gastrectomy. In China, the 2022 CSCO guidelines for the diagnosis and treatment of
gastric cancer also did not specify the priority of reconstruction methods, pointing out
that alternative reconstruction methods include Billroth-I, Billroth-II combine with
Braun anastomosis, Roux-en-Y anastomosis, and jejunal interposition. However, the number
of alternative methods indicates that no ideal reconstruction method has absolute
advantages. Therefore, in clinical practice, the specific choice of digestive tract
reconstruction method often needs to be determined by considering many factors, including
the location of the primary tumor, tumor stage, lymph node condition, anatomical
variation and patient's economic situation, etc., which are important factors affecting
the choice of digestive tract reconstruction method.
With the development of laparoscopic technique in recent years, totally laparoscopic
digestive tract reconstruction has become a hot spot in the surgical treatment of gastric
cancer. Laparoscopic digestive tract reconstruction has smaller incision and less trauma,
which is a higher-level laparoscopic surgery pursued by surgeons. However, for patients
undergoing radical gastrectomy for distal gastric cancer, totally laparoscopic distal
gastroduodenal anastomosis is technically difficult. Delta anastomosis was proposed by
Professor Kannaya in Japan in 2002. In this technique, the functional end to end
anastomosis of the posterior wall of the remnant gastroduodenal was completed by using
endoscopic linear staplers under totally laparoscopy, and the suture nails inside the
anastomosis were triangular. It is a widely used functional end to end anastomosis of
remnant gastroduodenum after distal gastrectomy under totally laparoscopic surgery.
However, because of the operation in the duodenum and stomach from broken should meet the
requirements of R0 resection of tumor, proper anastomotic tension, and blood supply of
free longer duodenal stump, its restrictive factors, poor controllability, security is
still not widely recognized, it can only be carried out in centers with rich experience
in laparoscopic surgery, and it is more suitable for early cases of gastric Antrum.
In 2016, Professor Changming Huang found that modified Delta anastomosis is safe and
feasible in early gastric cancer, but caution is still needed for locally advanced
gastric cancer, its incidence of postoperative complications and anastomotic leakage was
significantly higher than that of laparoscopic-assisted Billroth-I anastomosis.
In 1995, Oka et al. reported the use of circular stapler for functional end to end
anastomosis of remnant gastroduodenum in open distal gastric cancer radical resection. In
2004, they reported the results of 221 cases, showing that this anastomosis was
clinically safe and reliable. In 2007, Yang et al. in Korea confirmed that functional end
to end anastomosis was safe and feasible in 933 cases of distal gastric cancer, with
similar short-term outcomes compared with Billroth-II anastomosis. However, the clinical
staging of gastric cancer patients in Japan and Korea is mainly early stage, but in
China, the clinical staging of gastric cancer patients is mostly advanced stage.
In conclusion, traditional Billroth-I end-to-side anastomosis and Delta anastomosis
require an additional residual gastric tissue of at least 3cm. In addition, the safe
margin of the broken end of advanced gastric cancer requires a distance of at least 3-5
cm from the tumor, which often leads to higher anastomotic tension and significantly
increases the risk of anastomotic leakage. Therefore, we propose a new technique for
gastrointestinal reconstruction in laparoscopic distal radical gastrectomy in locally
advanced gastric cancer: Double-Stapling End-to-End Gastroduodenostomy Billroth-I
Anastomosis in Laparoscopy-Assisted Surgery. After previous practice, this anastomotic
method can not only ensure a safe surgical margin, but also retain more residual stomach,
so as to effectively solve the problem of anastomotic tension. It is a safe, simple,
physiological and economic anastomotic method.
Criteria for eligibility:
Study pop:
All eligible patients enrolled in this study would undergo double-stapling end-to-end
gastroduodenostomy Billroth-I anastomosis in laparoscopy-assisted surgery
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- Age from 18 to years (including 18 and 85years old)
- Pathological diagnosis of primary focus is gastric adenocarcinoma made by endoscopic
biopsy (papillary, tubular, mucinous, signet ring cell, poorly differentiated)
- cT1-4a, N+/-, M0 at preoperative evaluation
- No peritoneal metastasis or other distant metastases of gastric carcinoma (affirmed
by laparoscopic surgery and related imaging examinations)
- Expected curative resection through laparoscopic distal gastrectomy with D2
lymphadenectomy (include multiple primary lower gastric adenocarcinoma)
- Performance status of 0 or 1 on Eastern Cooperative Oncology Group scale (ECOG)
- Preoperative American Society of Anesthesiology score (ASA) classⅠ, Ⅱ or Ⅲ
- Major organs are functioning normally:
blood routine test (No blood transfusions in the last 14 days): HB≥90g/L, ANC≥1.5×109/L,
PLT≥80×109/L blood biochemical examination: BIL<1.5× upper limit of normal (ULN), ALT and
AST<2.5×ULN, Crea≤1×ULN.
- The subject is willing to participate in this clinical trail
Exclusion Criteria:
- History of previous upper abdominal surgery (include ESD/EMR, except laparoscopic
cholecystectomy)
- History of acute pancreatitis
- Regional fusion of enlarged lymph nodes by preoperative imaging (maximum diameter
>3cm)
- History of other malignant disease within past five years
- History of unstable angina, myocardial infarction, cerebral infraction, or cerebral
hemorrhage within past six months
- History of continuous systematic corticosteroids therapy within past one month
- Requirement of simultaneous surgery for other disease
- Emergency surgery due to complication (bleeding, or perforation) caused by gastric
cancer
- FEV1<50% of predicted values by pulmonary function test
- Women during pregnancy or breast-feeding
- Severe mental disorder
- Participating in other clinical studies simultaneously
- Refusing to sign the informed consent for the study
- Peritoneal implant or other distant metastases by intraoperative exploration
- Unresectable due to tumor reasons by intraoperative exploration
- Distal gastric cancer surgery cannot be performed after intraoperative exploration
- Duodenal bulb has been invaded by tumor or gastroduodenostomy cannot be performed
due to additional surgical resection cause by positive intraoperative frozen margin
Gender:
All
Minimum age:
18 Years
Maximum age:
85 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
West China Hospital, Sichuan University
Address:
City:
Chengdu
Zip:
610041
Country:
China
Status:
Recruiting
Contact:
Last name:
Yong Zhou, PhD
Phone:
+8618980605773
Email:
nutritoner@hotmail.com
Start date:
September 14, 2022
Completion date:
December 31, 2023
Lead sponsor:
Agency:
West China Hospital
Agency class:
Other
Source:
West China Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05545293
