Quality of life comparison between esophagogastrostomy and double tract reconstruction for proximal gastrectomy assessed by Postgastrectomy Syndrome Assessment Scale (PGSAS)‐45

Abstract Aim The current study compared the postoperative quality of life (QOL) between the esophagogastrostomy method (PGEG) and double tract method (PGDT) after proximal gastrectomy using the Postgastretomy Syndrome Assessment Scale (PGSAS)‐45. Methods Among the 2364 patients who received the PGSAS‐45 questionnaire, 300 PGEG and 172 PGDT cases responded. The main outcomes measures (MOMs) consisted of seven subscales (SS) covering symptoms, meals (amount and quality), ability to work, dissatisfaction with daily life, physical and mental component summary of the 8‐Item Short Form Health Survey (SF‐8), and change in body weight, and were compared between PGEG and PGDT. Results Overall, PGDT promoted significantly better constipation SS scores (p < 0.05), whereas PGEG tended to promote better body weight (BW) loss% (p < 0.10). A stratified analysis based on the remnant stomach size revealed that among those with a remnant stomach size of 1/2, PGDT had significantly better constipation and dumping SS scores (p < 0.05) and tended to have better working conditions (p < 0.10) compared to PGEG. Even among those with the remnant stomach size of 2/3, PGDT had significantly better diarrhea SS scores, lesser dissatisfaction with symptoms, and better dissatisfaction with daily life SS scores (p < 0.05) and tended to have better constipation SS scores and lesser dissatisfaction with work (p < 0.10) compared to PGEG. Conclusions After comparing the QOLs of PGEG and PGDT, the stratified analysis according to remnant stomach sizes of 1/2 and 2/3 revealed that PGDT was relatively superior to PGEG for several MOMs.


| INTRODUC TI ON
Advances in diagnostic and therapeutic techniques for gastric cancer have improved the early diagnosis of gastric cancer patients and prognosis of advanced gastric cancer. [1][2][3][4] As such, the long-term quality of life (QOL) after gastrectomy has also required attention.
Unfortunately, both Japan and Western countries have seen an increase in the incidence of cancers in the upper third of the stomach and gastroesophageal junction. [5][6][7] In Japan, the incidence of gastric cancer has decreased due to the decrease in the rate of H. pylori infection and the spread of H. pylori infection detection/eradication treatment in health checkups. 8 In such situations there is an increase in the rate of the upper gastric cancer. 9 Proximal gastrectomy has been a frequent treatment approach for early upper third gastric cancer. Various reconstruction methods have been used for proximal gastrectomy.
Among them, the esophagogastrostomy method (PGEG) and double tract method (PGDT) have recently been the most commonly utilized reconstruction methods in Japan. However, it remains unclear which reconstruction method is better for postoperative QOL.
A large retrospective study using the Postgastrectomy Syndrome Assessment Scale (PGSAS-45) reported that proximal gastrectomy promoted lower postgastrectomy burden than total gastrectomy with Roux-en-Y reconstruction. 10 Hence, proximal gastrectomy has become a potential option as a function-preserving surgery for early upper third gastric cancer. 11 Various reconstruction methods after proximal gastrectomy have been proposed for preventing esophageal reflux and achieving optimal food storage and outflow from the remnant stomach, which are considered crucial for maintaining postoperative QOL after proximal gastrectomy. A nationwide multi-institutional surveillance study ("PGSAS NEXT" study) was conducted to investigate the optimal gastrectomy procedures for F I G U R E 1 Structure of Postgastrectomy Syndrome Assessment Scale (PGSAS)-45 (domains/subdomains/items/subscales). In items or subscales with*; higher score indicating better condition. In items or subscales without*; higher score indicating worse 2 | ME THODS

| Patients
The patient inclusion criteria were as follows: (1) females or males aged 20 years or older; (2) cancer located at the upper third of the stomach or around the esophagogastric junction regardless of stage or histologic type; (3) achieved R0 resection; (4) no recurrence or metastasis; (5) more than 6 months after gastrectomy; (6) more than 6 months after the termination of former chemotherapy; (7) underwent gastrectomy only once; (8) performance status 0 or 1; (9) capable of understanding the questionnaire; (10) no other disease or previous surgery that may influence the results of the questionnaire aside from gastrectomy; (11) no organ failure or mental disease; (12) spontaneous agreement of the said person.
The patient exclusion criteria were as follows: (1) active dual malignancy; (2) synchronous surgery with exception of the resection or extraction of the perigastric organs to accomplish gastrectomy or lymph node dissection, as well as that equivalent to cholecystectomy.

| QOL assessment using the PGSAS-45 questionnaire
The PGSAS-45 is composed of questions pertaining to 45 items ( Figure 1), which include eight items from the existing the 8-Item Short Form Health Survey (SF-8), 12 15

| Study methods
This study utilized continuous sampling from a central registration system for participant enrollment. The questionnaire was distributed to eligible patients. Patients were instructed to return completed forms to the data center. All QOL data from questionnaires were matched with individual patient data collected via case report forms.
The methods used for measuring the distance from the dia-

| Statistics
Patient characteristics and main outcome measures were compared between PGEG and PGDT using t-tests and Fisher's exact tests. All outcome measures were further analyzed using multiple regression analyses. Ten factors-reconstruction method, age, sex, postoperative period, operative approach, preservation of the celiac branch   anti-reflux method, and three unknown cases. Reconstruction procedures were not regulated by the protocol and depended on the principle of the institution or discretion of each surgeon.

| Patient characteristics
Patient characteristic of both groups are summarized ( Table 1). The

| Comparison of postoperative QOL between PGEG and PGDT
The main outcome measures of PGSAS-45 were compared between the PGEG and PGDT groups (  (Table 3).
Subsequently, a stratified analysis based on the remnant stomach size was performed for those with a remnant stomach size of approximately 1/2 ( Table 4) and 2/3 (

| DISCUSS ION
The Japan Postgastrectomy Syndrome Working Party has created a questionnaire (i.e., PGSAS-45) to evaluate postgastrectomy disorders, utilizing the Japanese version for clinical applications. 15 According to the Japanese gastric cancer treatment guidelines, standard gastrectomy is defined as the resection of at least twothirds of the stomach, including D2 lymph node dissection. 11 The PGSAS study showed that proximal gastrectomy promoted better QOL compared to total gastrectomy with Roux-en-Y reconstruction, leading to the widespread introduction of proximal gastrectomy.
However, the optimal proximal gastrectomy reconstruction method has yet to be established. 10,17 Following the previous PGSAS study, "the PGSAS NEXT study," a study on the optimal gastrectomy procedures to improve postoperative QOL for the cancer located at the upper third of the stomach or around the esophagogastric junction using the PGSAS-45 questionnaire, was planned.
Various reconstruction methods have been utilized for proximal gastrectomy procedures. Japanese gastric cancer treatment guidelines have proposed three types of reconstruction methods for proximal gastrectomy: esophagogastrostomy, jejunal interposition, and double tract method. 11 Analysis of the proximal gastrectomy cases collected in this study revealed that PGEG and PGDT were most popular reconstruction methods utilized in Japan.
Inada et al. reported that scores for esophageal reflux and dissatisfaction with meals were higher in patients who had not undergone an anti-reflux procedure in the PGSAS study, which indicated that an appropriate anti-reflux method is strongly recommended for PGEG. 18 In the current study, 276 cases (93%) underwent anti-reflex procedures for PGEG, whereas only 21 cases (7%) did not. The types of anti-reflux methods for PGEG include the double flap method, 19,20 creation of pseudofornix and/or Hisoid angle, fundoplication, 21,22 and SOFY, 16  and an escape route using gastrojejunostomy. 24,25 The double tract method requires plural anastomosis (i.e., esophagojejunostomy, jejunogastrostomy, and jejunojejunostomy), although each anastomosis procedure is technically easy and familiar to many surgeons. Since the risk of an internal hernia is a concern, it is better to do suture closure of the mesentery gap caused by reconstruction.
From the background of both groups, the laparoscopic approach for proximal gastrectomy has been the mainstream approach for gastric cancer. In the previous PGSAS study, the laparoscopic surgery rate for proximal gastrectomy was only 17.2%, 10 whereas that for proximal gastrectomy in the current PGSAS NEXT study, which was conducted nearly 9 years after the PGSAS study, has since increased.
Currently in Japan, laparoscopic proximal gastrectomy is growing   The current study showed that the QOL of the PGDT groups was slightly superior to that of the PGEG group across several main out- Given that the procedures employed for PGEG and PGDT are still incomplete, further techniques for improving both methods and studies revaluating PGEG and PGDT in the future are required.
One limitation of the present study was its retrospective nature and the unbalanced number of patients in each group. A welldesigned prospective study should therefore be conducted in the future.

| CON CLUS ION
Our results indicated that the QOL of the PGDT group was slightly superior to that of the PGEG group for several main outcome measures of the PGSAS-45 during stratified analysis according to remnant stomach sizes of around 1/2 and 2/3, with a small effect size.
The revaluation of both reconstruction methods after compensating the shortcomings of each procedure (i.e., preventing esophageal reflux for PGEG and maintaining physiological food passage for PGDT) will be a substantial issue in the future.

ACK N OWLED G M ENT
This study was supported by a grant from the Jikei University and the Japanese Gastric Cancer Association. The authors thank all physicians who participated in this study and the patients whose cooperation made this study possible.

FU N D I N G I N FO R M ATI O N
This study was supported by a grant from the Jikei University and the Japanese Gastric Cancer Association.

Dr. H.M. is an editorial member at the Annals of Gastroenterological
Surgery. The other authors declare that they have no conflicts of interest.

E TH I C S S TATEM ENTS
This study was approved by the local ethics committees of each par-