{"entity":{"id":"idea-gbc-t1b-simple-cholecystectomy-prospective-study","kind":"idea","name":"Test whether T1b gallbladder cancer needs the second operation at all","aka":[],"tldr":"Guidelines send everyone whose chance-found gallbladder cancer has just reached the muscle layer back for liver and lymph node surgery, yet the largest international series found 95 in 100 alive without the disease at five years whether or not they had it. A prospective study could spare thousands of operations, or confirm they are needed.","summary":"In 237 T1b patients from 14 centres in Korea, Japan, Chile and the United States, five-year disease-specific survival was 93.7 percent after simple cholecystectomy and 95.5 percent after extended cholecystectomy (p=0.496), with no difference by nodes or location (Kim 2018). Pawlik's series found no liver residual disease in T1 tumours but nodal metastasis in 12.5 percent. The evidence is retrospective and confounded by selection, and T1b itself is hard to standardise on pathology. A prospective registry with central pathology review, or a non-inferiority trial of observation with imaging surveillance against extended cholecystectomy, is the missing study.","asOf":"2026-09-24","links":[{"label":"Kim et al.: optimal surgical treatment of T1b gallbladder cancer, 14 centres (J Hepatobiliary Pancreat Sci 2018)","url":"https://europepmc.org/article/MED/30562839"}],"tags":["gallbladder-evidence"],"related":[],"cancers":["gallbladder"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":["radical-cholecystectomy","incidental-gallbladder-cancer","tnm-staging","de-escalation"],"trials":[],"people":[],"bottlenecks":["b-trial-design","b-surgery-radiation-innovation"],"keyPapers":["paper-kim-t1b-gallbladder-cancer-international-jhbps-2018","paper-pawlik-incidental-gallbladder-cancer-residual-disease-jgs-2007"],"journals":[],"dependsOn":[],"notes":[],"hypothesis":"In T1b gallbladder cancer with negative cystic duct margin and no perforation, simple cholecystectomy with surveillance is non-inferior to extended cholecystectomy for five-year disease-specific survival, with a margin of 5 percentage points.","rationale":"Observed five-year disease-specific survival above 93 percent in both arms leaves little room for benefit; extended cholecystectomy carries operative risk and cost in an elderly population.","test":"International prospective registry with central pathology and pre-specified comparison, or a randomised non-inferiority trial (about 600 patients for a 5-point margin at 94 percent baseline) with nodal sampling as a secondary randomisation.","maturity":"early-clinical","actor":"research","cost":"medium","horizonYears":8},"route":"/ideas/idea-gbc-t1b-simple-cholecystectomy-prospective-study/","neighbours":{"cancer":[{"id":"gallbladder","kind":"cancer","name":"Gallbladder cancer","route":"/cancers/gallbladder/"},{"id":"incidental-gallbladder-cancer","kind":"cancer","name":"Incidental gallbladder cancer (found after cholecystectomy)","route":"/cancers/incidental-gallbladder-cancer/"}],"term":[{"id":"de-escalation","kind":"term","name":"De-escalation, escalation and response-adapted therapy","route":"/terms/de-escalation/"},{"id":"radical-cholecystectomy","kind":"term","name":"Radical (extended) cholecystectomy","route":"/terms/radical-cholecystectomy/"},{"id":"tnm-staging","kind":"term","name":"TNM staging","route":"/terms/tnm-staging/"}],"bottleneck":[{"id":"b-surgery-radiation-innovation","kind":"bottleneck","name":"Surgery and radiotherapy cure most, get least","route":"/bottlenecks/b-surgery-radiation-innovation/"},{"id":"b-trial-design","kind":"bottleneck","name":"Trial design, endpoints and cost","route":"/bottlenecks/b-trial-design/"}],"paper":[{"id":"paper-pawlik-incidental-gallbladder-cancer-residual-disease-jgs-2007","kind":"paper","name":"Incidence of finding residual disease for incidental gallbladder carcinoma: implications for re-resection","route":"/key-papers/paper-pawlik-incidental-gallbladder-cancer-residual-disease-jgs-2007/"},{"id":"paper-kim-t1b-gallbladder-cancer-international-jhbps-2018","kind":"paper","name":"Optimal surgical treatment in patients with T1b gallbladder cancer: An international multicenter study","route":"/key-papers/paper-kim-t1b-gallbladder-cancer-international-jhbps-2018/"}],"roadmap":[{"id":"gallbladder-cancer-roadmap","kind":"roadmap","name":"Gallbladder cancer roadmap: from a chance finding at gallstone surgery to a disease with its own trials","route":"/roadmaps/gallbladder-cancer-roadmap/"}]}}