Z Gastroenterol 2018; 56(08): e318
DOI: 10.1055/s-0038-1668964
Gastroenterologische Onkologie
Gallenblasen- und Gallengangskarzinome: Von der Epidemiologie und Pathogenese zur medikamentösen, interventionellen und operativen Therapie – Donnerstag, 13. September 2018, 08:00 – 09:44, 22a
Georg Thieme Verlag KG Stuttgart · New York

„The German- Registry” of Incidental gallbladder cancer and the GAIN- phase III trial – transformation from a registry to treatment platform due to a trial in trial concept

TO Goetze
1   Krankenhaus Nordwest, Institute of Clinical Cancer Research, Frankfurt, Deutschland
V Paolucci
2   Ketteler- Krankenhaus, Chirurgische Klinik, Offenbach, Deutschland
SE Al-Batran
1   Krankenhaus Nordwest, Institute of Clinical Cancer Research, Frankfurt, Deutschland
› Author Affiliations
Further Information

Publication History

Publication Date:
13 August 2018 (online)



The biggest biliary platform in Europe – the German- Registry (GR) shows significant survival benefit for radical resection (RR) in gallbladder carcinoma. But nevertheless results for T2 – 3 are still disappointing even after RR.


For data analysis the GR was used. Currently more than 1100 cases of incidental gallbladder carcinoma (IGBC) are prospectively registered. Based on the GR a multicenter a neoadjuvant trail (GAIN) with the support of the DFG/AIO/CALGP/ACO has been started in 20 centers in Germany. In addition a trial in trial concept is planned. GAIN is a randomized multicenter phase III study for T2 – 3 IGBC's + resectable and borderline resectable biliary tract cancers (BTC), evaluating the role of neoadjuvant CTX with Gem/Cis in a multimodal setting in front of and after surgery vs. upfront surgery alone. If screened pts. is not eligible for curative treatment, pts. will be directly included in another 1st. line trial (trial- in- trial concept) under the direction of the GR. All IGBC's in addition will be directly registered in the GR.


In the GR (n> 1100pts) in T1b- T3 cases there is a significant survival benefit for patients with IRR. Wedge resection of the liver showed good data in T1b and T2. For T3 more radical techniques showed better results. Less than 50% of T2 – 3 tumors in the GR have had RR. Due to limited abstract characters no more data can be written.


There is a significant benefit after RR in T1b- T3 IGBC but the results in T2 – 3 are disappointing. Data of current (PRODIGE 12, BILCAP) adjuvant trials are inconsistent. Therefore the multimodal concept based on a biliary network is needed. The GAIN trial is supported by the DFG EudraCT 2017 – 004444 – 38; DFG Projektnummer 316590476 and is also supported by the AIO, ACO, CALGP. Due to the trial in trial concepts patients screened for GAIN but are candidates for 1st line will be directly included in a 1st line trial without time delay so project closes a healthcare gap. The data of the GR were already able to change the current treatment standards for GBCA in Germany, reflected by the current S3- Guidelines (2018/AWMF -Register-Nr. 021/008). So GR will now transform to treatment platform and potentially create a new way how to treat biliary pts.